PROPEL: Pelvic Floor Repair Systems for Prolapse Repair
Sponsor
ASTORA Women's Health (Industry)
Overall Status
Completed
CT.gov ID
NCT00638235
Collaborator
(none)
725
28
76.1
25.9
0.3
Study Details
Study Description
Brief Summary
-
This is a prospective, multi-center, post market study, which will be conducted under a common protocol.
-
The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
-
The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
-
The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
-
Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
725 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
Study Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Feb 1, 2011
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Phase I (IntePro, US only) AMS Apogee™ with IntePro(Began May 2006 - Closed) |
Device: AMS Apogee™ with IntePro
Mesh implant for posterior wall pelvic organ prolapse
|
| Phase I (InteXen LP, US only) AMS Apogee™ with InteXen LP (Began May 2006 - Closed) |
Device: AMS Apogee™ with Intexen LP
Graft implant for posterior wall pelvic organ prolapse
|
| Phase II (France only) AMS Perigee™ with IntePro (Began February 2007 - Closed) |
Device: AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
|
| Phase III/IV (Perigee IntePro Lite, US only) AMS Perigee™ with IntePro Lite (Began April 2007 - Closed) |
Device: AMS Perigee™ with IntePro Lite
Mesh implant for anterior wall pelvic organ prolapse
|
| Phase III/IV (Apogee IntePro Lite, US only) AMS Apogee™ with IntePro Lite (Began April 2007 - Closed) |
Device: AMS Apogee™ with IntePro Lite
Mesh implant for posterior wall pelvic organ prolapse
|
| Phase V (Elevate Posterior IntePro Lite, US & EU) AMS Elevate™ Apical & Posteiror with IntePro Lite (Began April 2008 - Closed) |
Device: AMS Elevate™ Apical & Posteiror with IntePro Lite
Mesh implant for apical and posterior wall pelvic organ prolapse
|
| Phase V (Elevate Posterior InteXen, US only) AMS Elevate™ Apical & Posteiror with IntXen LP (Began April 2008 - Closed) |
Device: AMS Elevate™ Apical & Posteiror with IntXen LP
Graft implant for apical and posterior wall pelvic organ prolapse
|
| Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only) AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed) |
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Mesh implant for anteiror and apical wall pelvic organ prolapse
|
| Phase VII (Elevate Anterior Gen 2, US & EU) AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 2, Began April 2009 - Closed) |
Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Mesh implant for anteiror and apical wall pelvic organ prolapse
|
Outcome Measures
Primary Outcome Measures
- Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure [12-months]
Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure [12-months]
Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure [12-months]
Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Secondary Outcome Measures
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [6 Months]
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.
- Procedural Time [Approximately 30 minutes]
Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes
- Estimated Blood Loss [Approximately 30 minutes]
Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml
- Percent of Subjects Experiencing Major Device Related Complications [Through 24 months]
This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure
- Rate of Graft Extrusions [Through 24 months]
Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall
- Rates of de Novo or Worsening Urinary and/or Anal Incontinence [Through 24 months]
Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence
- Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure [baseline and 6 weeks]
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) [6 Months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
- Surgical Revision Rate [Through 24 months]
The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months [6 months]
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months [24 months]
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) [12 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) [24 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) [6 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) [12 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) [24 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
- Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) [6 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
- Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) [12 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
- Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) [24 months]
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
- Wong-Baker Faces Pain Scale at 3 Months Post Procedure [baseline and 3 months]
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [12 months]
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 [baseline and 24 months]
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M [baseline and 6 months]
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M [baseline and 12 months]
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M [baseline and 24 months]
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M [baseline and 6 months]
Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M [baseline and 12 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M [baseline and 24 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M [baseline and 6 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M [baseline and 6 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M [baseline and 12 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M [baseline and 24 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M [baseline and 12 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M [baseline and 24 months]
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure [6 months]
Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure [24 months]
Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure [6 months]
Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure [24 months]
Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Other Outcome Measures
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure [6 months]
Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
- Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure [24 months]
Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion Criteria:
-
The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse.
-
Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
-
Subject has active or latent systemic infection or signs of tissue necrosis.
-
Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
-
Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
-
Subject has had radiation therapy to the pelvic area.
-
Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
-
Subject has a known hypersensitivity to the graft material(s).
-
Subject has uncontrolled diabetes.
-
Subject is on any medication which could result in compromised immune response, such as immune modulators.
-
Subject was involved in any other research trial < 30 days of enrollment into this study.
-
Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study.
-
Subject is unwilling or unable to give valid informed consent.
-
Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
-
Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente - Dept. of Obstetrics & Gynecology | Downey | California | United States | 90242 |
| 2 | Institute for Women's Health & Body | Wellington | Florida | United States | 33414 |
| 3 | Atlanta Medical Research Institute | Alpharetta | Georgia | United States | 30005 |
| 4 | Rosemark Womencare Specialists | Idaho Falls | Idaho | United States | 83404 |
| 5 | Fore River Urology | Portland | Maine | United States | 04102 |
| 6 | Maine Medical Partners | Portland | Maine | United States | 04102 |
| 7 | Female Pelvic Health | Whitinsville | Massachusetts | United States | 01588 |
| 8 | Female Pelvic Medicine and Urogynecology Inst. of Michigan | Grand Rapids | Michigan | United States | 49503 |
| 9 | Michigan Medical P.C. | Grand Rapids | Michigan | United States | 49546 |
| 10 | Women's Health Care Specialists, PC | Paw Paw | Michigan | United States | 49079 |
| 11 | Metro Urology | Plymouth | Minnesota | United States | 55441 |
| 12 | Piedmont Urology Associates | Gastonia | North Carolina | United States | 28054 |
| 13 | Huey & Weprin Obstetrics & Gynecology | Englewood | Ohio | United States | 45322 |
| 14 | South Carolina OB/GYN | Columbia | South Carolina | United States | 29201 |
| 15 | University of Tennessee - Dept of Obstetrics & Gynecology | Memphis | Tennessee | United States | 38103 |
| 16 | Texas Tech University Health Science Center - OB/GYN Department | El Paso | Texas | United States | 79905 |
| 17 | Eastern Virginia Medical School | Norfolk | Virginia | United States | 23507 |
| 18 | UZ Leuven Dept of Urology | Leuven | Belgium | ||
| 19 | CMC Beau Soleil | Montpellier | France | 34070 | |
| 20 | Service urologie de Paris l'Hôpital Tenon | Paris | France | 75020 | |
| 21 | Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest | Paris | France | ||
| 22 | CHU de Rouen - Pavillon Derocque - Rez de Chaussée | Rouen | France | 76031 | |
| 23 | Clinique Adassa | Strasbourg | France | 67082 | |
| 24 | Dr. Rainer Lange | Alzey | Germany | 55232 | |
| 25 | Beckenbodenzentrum Munich | Munich | Germany | 81679 | |
| 26 | University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics | Amsterdam | Netherlands | 1105AZ | |
| 27 | Hospitalet General de l'Hospitalet | Barcelona | Spain | 08906 | |
| 28 | University Hospital of Leicester NHS Trust | Leicester | United Kingdom | LE5 4PW |
Sponsors and Collaborators
- ASTORA Women's Health
Investigators
- Principal Investigator: James C. Lukban, DO, Eastern Virginia Medical School
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT00638235
Other Study ID Numbers:
- 1004
- NCT00793039
First Posted:
Mar 19, 2008
Last Update Posted:
Oct 28, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by ASTORA Women's Health
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Phases duration: Phase I: May 2006 - Oct 2009 Phase II: Feb 2007 - Jun 2010 Phase III/IV: Apr 2007 - May 2010 Phase V: Apr 2008 - Jan 2011 Phase VI: Oct 2008 - Mar 2010 Phase VII: Apr 2009 - Feb 2012 |
|---|---|
| Pre-assignment Detail | Only those subjects who meet all study criteria, provide written consent and are implanted with an AMS PFR System device for prolapse repair will be considered evaluable for analysis in the study |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Period Title: Overall Study | |||||||||
| STARTED | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| COMPLETED | 110 | 23 | 63 | 46 | 42 | 113 | 23 | 34 | 124 |
| NOT COMPLETED | 31 | 3 | 18 | 10 | 13 | 26 | 0 | 1 | 18 |
Baseline Characteristics
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) | Total of all reporting groups |
| Overall Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 | 698 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||||
| Mean (Standard Deviation) [years] |
59.7
(12.2)
|
63.4
(9.0)
|
69.7
(10.9)
|
63.4
(11.1)
|
63.3
(11.8)
|
62.5
(11.6)
|
63.4
(9.6)
|
65.4
(8.4)
|
63.9
(9.8)
|
NA
(0)
|
| Sex: Female, Male (Count of Participants) | ||||||||||
| Female |
141
100%
|
26
100%
|
81
100%
|
56
100%
|
55
100%
|
139
100%
|
23
100%
|
35
100%
|
142
100%
|
698
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure |
|---|---|
| Description | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a "zero" is indicated, no subjects meeting this criteria were enrolled. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 117 | 24 | 0 | 0 | 44 | 120 | 23 | 0 | 0 |
| Number (95% Confidence Interval) [percentage of participant] |
93.2
|
100
|
93.2
|
92.5
|
100
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
|---|---|
| Description | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 67 | 8 | 24 | 16 | 18 | 47 | 9 | 16 | 51 |
| PISQ-12 mean score at baseline |
32.5
(7.1)
|
32.1
(5.6)
|
34.8
(5.5)
|
33.4
(5.6)
|
32.4
(6.4)
|
34.0
(5.9)
|
33.9
(4.4)
|
34.0
(4.8)
|
32.6
(8.1)
|
| PISQ-12 mean score at 6M |
37.1
(5.7)
|
36.8
(7.2)
|
36.8
(4.7)
|
35.4
(5.9)
|
35.4
(5.9)
|
36.3
(5.5)
|
35.0
(7.7)
|
38.1
(6.4)
|
36.6
(6.1)
|
| Title | Procedural Time |
|---|---|
| Description | Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes |
| Time Frame | Approximately 30 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| Mean (Standard Deviation) [minutes] |
44.8
(20.3)
|
40.8
(17.7)
|
50.2
(38.3)
|
42.4
(16.4)
|
51.7
(23.1)
|
45.8
(19.2)
|
48.6
(14.8)
|
63.5
(19.0)
|
54.6
(21.5)
|
| Title | Estimated Blood Loss |
|---|---|
| Description | Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml |
| Time Frame | Approximately 30 minutes |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 139 | 26 | 80 | 56 | 55 | 139 | 23 | 35 | 142 |
| Mean (Standard Deviation) [milliliters] |
68.6
(67.8)
|
67.7
(43.9)
|
48.8
(29.3)
|
58.4
(54.7)
|
58.9
(44.6)
|
55.4
(45.7)
|
62.4
(39.0)
|
84.4
(60.9)
|
75.5
(76.3)
|
| Title | Percent of Subjects Experiencing Major Device Related Complications |
|---|---|
| Description | This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure |
| Time Frame | Through 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total subjects experienced major complications(%) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| Perforation |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Graft erosion |
0.7
0.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Serious infe |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Death related to procedure or device |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Blood loss |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0.7
0.5%
|
| Title | Rate of Graft Extrusions |
|---|---|
| Description | Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall |
| Time Frame | Through 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Rate of subjects experiencing graft exposure through the vagina (%) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| Number [Percentage of participants] |
9.2
6.5%
|
0
0%
|
3.7
4.6%
|
5.4
9.6%
|
7.3
13.3%
|
7.9
5.7%
|
0
0%
|
5.7
16.3%
|
5.6
3.9%
|
| Title | Rates of de Novo or Worsening Urinary and/or Anal Incontinence |
|---|---|
| Description | Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence |
| Time Frame | Through 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Rate of subjects experiencing different type of incontinenece (%) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects had their 24M visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| Urinary Incontinence - de novo Stress |
0
0%
|
3.8
14.6%
|
12.3
15.2%
|
1.8
3.2%
|
0
0%
|
0
0%
|
0
0%
|
11.4
32.6%
|
4.2
3%
|
| Urinary Incontinence - worsening Stress |
0
0%
|
0
0%
|
8.6
10.6%
|
0
0%
|
0
0%
|
0.7
0.5%
|
0
0%
|
11.4
32.6%
|
0
0%
|
| Urinary Incontinence - de novo Urge |
0
0%
|
0
0%
|
1.2
1.5%
|
1.8
3.2%
|
1.8
3.3%
|
0
0%
|
0
0%
|
0
0%
|
0.7
0.5%
|
| Urinary Incontinence - Worsening Urge |
0
0%
|
0
0%
|
0
0%
|
1.8
3.2%
|
0
0%
|
0
0%
|
4.3
18.7%
|
2.9
8.3%
|
0.7
0.5%
|
| Urinary Incontinence - de novo Mixed |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2.9
8.3%
|
0
0%
|
| Urinary Incontinence - Worsening Mixed |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2.9
8.3%
|
0.7
0.5%
|
| Fecal Incontinence |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0.7
0.5%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure |
|---|---|
| Description | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure |
| Time Frame | baseline and 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 136 | 25 | 79 | 55 | 53 | 134 | 22 | 34 | 140 |
| Mean level of pain per WBPS at baseline |
1.9
(2.5)
|
2.0
(2.2)
|
1.5
(1.8)
|
1.2
(2.1)
|
1.4
(2.1)
|
1.8
(2.2)
|
2.1
(2.9)
|
1.1
(1.5)
|
1.4
(2.0)
|
| Mean level of pain per WBPS at 6 weeks post-op |
0.7
(1.3)
|
0.2
(0.6)
|
0.9
(1.5)
|
0.5
(1.1)
|
0.7
(1.4)
|
0.6
(1.3)
|
0.8
(1.4)
|
0.5
(1.0)
|
0.7
(1.3)
|
| Title | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US & Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 129 | 26 | 73 | 47 | 46 | 131 | 23 | 34 | 131 |
| Did not answer this question |
0.8
0.6%
|
0
0%
|
5.5
6.8%
|
0
0%
|
0
0%
|
2.3
1.7%
|
0
0%
|
2.9
8.3%
|
0.8
0.6%
|
| Worse than before surgery |
0
0%
|
0
0%
|
0
0%
|
4.3
7.7%
|
2.2
4%
|
1.5
1.1%
|
0
0%
|
2.9
8.3%
|
1.5
1.1%
|
| No improvement from before surgery |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0.8
0.6%
|
0
0%
|
0
0%
|
1.5
1.1%
|
| Some improvement from before surgery |
17.1
12.1%
|
15.4
59.2%
|
8.2
10.1%
|
21.3
38%
|
8.7
15.8%
|
21.4
15.4%
|
13.0
56.5%
|
11.8
33.7%
|
12.2
8.6%
|
| A lot of improvement from before surgery |
82.2
58.3%
|
84.6
325.4%
|
86.3
106.5%
|
74.5
133%
|
89.1
162%
|
74.0
53.2%
|
87.0
378.3%
|
82.4
235.4%
|
84.0
59.2%
|
| Title | Surgical Revision Rate |
|---|---|
| Description | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. |
| Time Frame | Through 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Percentage of total subjects experienced surgical revision (%) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 141 | 26 | 81 | 56 | 55 | 139 | 23 | 35 | 142 |
| Number [Percentage of participants] |
7.1
5%
|
0
0%
|
11.1
13.7%
|
5.4
9.6%
|
3.6
6.5%
|
8.6
6.2%
|
4.3
18.7%
|
25.7
73.4%
|
9.2
6.5%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months |
|---|---|
| Description | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 125 | 26 | 73 | 47 | 46 | 126 | 23 | 34 | 131 |
| Posterior Compartment Success |
94.4
67%
|
100
384.6%
|
NA
NaN
|
NA
NaN
|
91.3
166%
|
96.8
69.6%
|
100
434.8%
|
NA
NaN
|
NA
NaN
|
| Apical Compartment Success |
94.7
67.2%
|
100
384.6%
|
NA
NaN
|
NA
NaN
|
100
181.8%
|
92.5
66.5%
|
90.9
395.2%
|
90.0
257.1%
|
98.8
69.6%
|
| Anterior Compartment Success |
NA
NaN
|
NA
NaN
|
76.7
94.7%
|
91.5
163.4%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
61.8
176.6%
|
86.3
60.8%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months |
|---|---|
| Description | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 108 | 23 | 68 | 46 | 44 | 106 | 23 | 0 | 125 |
| Posterior Compartment Success |
93.5
66.3%
|
95.7
368.1%
|
NA
NaN
|
NA
NaN
|
90.9
165.3%
|
91.5
65.8%
|
90.9
395.2%
|
NA
NaN
|
|
| Apical Compartment Success |
84.4
59.9%
|
100
384.6%
|
NA
NaN
|
NA
NaN
|
75.0
136.4%
|
88.2
63.5%
|
100
434.8%
|
96.2
274.9%
|
|
| Anterior Compartment Success |
NA
NaN
|
NA
NaN
|
69.1
85.3%
|
87.0
155.4%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
81.6
233.1%
|
| Title | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 71 | 45 | 44 | 126 | 23 | 34 | 125 |
| Did not answer this question |
0
0%
|
4.2
16.2%
|
7.0
8.6%
|
0
0%
|
0
0%
|
1.6
1.2%
|
0
0%
|
2.9
8.3%
|
0
0%
|
| Worse than before surgery |
1.7
1.2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1.6
1.2%
|
0
0%
|
0
0%
|
0.8
0.6%
|
| No improvement from before surgery |
0
0%
|
4.2
16.2%
|
0
0%
|
0
0%
|
2.3
4.2%
|
2.4
1.7%
|
0
0%
|
0
0%
|
2.4
1.7%
|
| Some improvement from before surgery |
17.6
12.5%
|
12.5
48.1%
|
14.1
17.4%
|
13.3
23.8%
|
4.5
8.2%
|
23.0
16.5%
|
26.1
113.5%
|
8.8
25.1%
|
6.4
4.5%
|
| A lot of improvement from before surgery |
80.7
57.2%
|
79.2
304.6%
|
78.9
97.4%
|
86.7
154.8%
|
93.2
169.5%
|
71.4
51.4%
|
73.9
321.3%
|
88.2
252%
|
90.4
63.7%
|
| Title | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 110 | 23 | 63 | 46 | 42 | 113 | 23 | 0 | 124 |
| Did not answer this question |
0
0%
|
4.3
16.5%
|
11.1
13.7%
|
2.2
3.9%
|
0
0%
|
0.9
0.6%
|
0
0%
|
0.8
2.3%
|
|
| Worse than before surgery |
2.7
1.9%
|
0
0%
|
0
0%
|
4.3
7.7%
|
2.4
4.4%
|
4.4
3.2%
|
0
0%
|
0.8
2.3%
|
|
| No improvement from before surgery |
0.9
0.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
3.5
2.5%
|
0
0%
|
1.6
4.6%
|
|
| Some improvement from before surgery |
10.9
7.7%
|
4.3
16.5%
|
7.9
9.8%
|
17.4
31.1%
|
11.9
21.6%
|
20.4
14.7%
|
30.4
132.2%
|
12.1
34.6%
|
|
| A lot of improvement from before surgery |
85.5
60.6%
|
91.3
351.2%
|
81.0
100%
|
76.1
135.9%
|
85.7
155.8%
|
70.8
50.9%
|
69.6
302.6%
|
84.7
242%
|
| Title | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 129 | 26 | 73 | 47 | 46 | 131 | 23 | 34 | 131 |
| Did not answer this question |
0.8
0.6%
|
0
0%
|
5.5
6.8%
|
0
0%
|
0
0%
|
2.3
1.7%
|
0
0%
|
0
0%
|
0.8
0.6%
|
| Not at all satisfied |
0.8
0.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1.5
1.1%
|
0
0%
|
2.9
8.3%
|
3.1
2.2%
|
| Slightly satisfied |
0.8
0.6%
|
3.8
14.6%
|
0
0%
|
2.1
3.8%
|
2.2
4%
|
4.6
3.3%
|
0
0%
|
2.9
8.3%
|
1.5
1.1%
|
| Moderately satisfied |
11.6
8.2%
|
3.8
14.6%
|
6.8
8.4%
|
6.4
11.4%
|
4.3
7.8%
|
12.2
8.8%
|
0
0%
|
5.9
16.9%
|
5.3
3.7%
|
| Very satisfied |
34.1
24.2%
|
38.5
148.1%
|
47.9
59.1%
|
46.8
83.6%
|
34.8
63.3%
|
38.2
27.5%
|
47.8
207.8%
|
61.8
176.6%
|
40.5
28.5%
|
| Extremely satisfied |
51.9
36.8%
|
53.8
206.9%
|
39.7
49%
|
44.7
79.8%
|
58.7
106.7%
|
41.2
29.6%
|
52.2
227%
|
26.5
75.7%
|
48.9
34.4%
|
| Title | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 71 | 45 | 44 | 126 | 23 | 34 | 125 |
| Did not answer this question |
0
0%
|
4.2
16.2%
|
7.0
8.6%
|
0
0%
|
0
0%
|
0.8
0.6%
|
0
0%
|
2.9
8.3%
|
0
0%
|
| Not at all satisfied |
0.8
0.6%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2.4
1.7%
|
0
0%
|
0
0%
|
0.8
0.6%
|
| Slightly satisfied |
4.2
3%
|
4.2
16.2%
|
0
0%
|
0
0%
|
2.3
4.2%
|
2.4
1.7%
|
8.7
37.8%
|
0
0%
|
4.8
3.4%
|
| Moderately satisfied |
13.4
9.5%
|
8.3
31.9%
|
9.9
12.2%
|
17.8
31.8%
|
6.8
12.4%
|
13.5
9.7%
|
4.3
18.7%
|
8.8
25.1%
|
3.2
2.3%
|
| Very satisfied |
32.8
23.3%
|
33.3
128.1%
|
45.1
55.7%
|
40
71.4%
|
40.9
74.4%
|
42.1
30.3%
|
26.1
113.5%
|
52.9
151.1%
|
32.8
23.1%
|
| Extremely satisfied |
48.7
34.5%
|
50
192.3%
|
38.0
46.9%
|
42.2
75.4%
|
50.0
90.9%
|
38.9
28%
|
60.9
264.8%
|
35.3
100.9%
|
58.4
41.1%
|
| Title | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 110 | 23 | 63 | 46 | 42 | 113 | 23 | 0 | 124 |
| Did not answer this question |
0
0%
|
4.3
16.5%
|
11.1
13.7%
|
2.2
3.9%
|
0
0%
|
0.9
0.6%
|
0
0%
|
0.8
2.3%
|
|
| Not at all satisfied |
3.6
2.6%
|
0
0%
|
0
0%
|
4.3
7.7%
|
2.4
4.4%
|
2.7
1.9%
|
0
0%
|
2.4
6.9%
|
|
| Slightly satisfied |
1.8
1.3%
|
0
0%
|
0
0%
|
2.2
3.9%
|
4.8
8.7%
|
8.0
5.8%
|
0
0%
|
3.2
9.1%
|
|
| Moderately satisfied |
11.8
8.4%
|
4.3
16.5%
|
6.3
7.8%
|
8.7
15.5%
|
9.5
17.3%
|
9.7
7%
|
8.7
37.8%
|
5.6
16%
|
|
| Very satisfied |
23.6
16.7%
|
26.1
100.4%
|
44.4
54.8%
|
41.3
73.8%
|
35.7
64.9%
|
40.7
29.3%
|
47.8
207.8%
|
29.8
85.1%
|
|
| Extremely satisfied |
59.1
41.9%
|
65.2
250.8%
|
38.1
47%
|
41.3
73.8%
|
47.6
86.5%
|
38.1
27.4%
|
43.5
189.1%
|
58.1
166%
|
| Title | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 129 | 26 | 73 | 47 | 46 | 131 | 23 | 34 | 131 |
| Did not answer this question |
2.3
1.6%
|
0
0%
|
5.5
6.8%
|
0
0%
|
0
0%
|
2.3
1.7%
|
0
0%
|
0
0%
|
0.8
0.6%
|
| Yes |
94.6
67.1%
|
100
384.6%
|
94.5
116.7%
|
95.7
170.9%
|
93.5
170%
|
96.9
69.7%
|
100
434.8%
|
97.1
277.4%
|
96.9
68.2%
|
| No |
3.1
2.2%
|
0
0%
|
0
0%
|
4.3
7.7%
|
6.5
11.8%
|
0.8
0.6%
|
0
0%
|
2.9
8.3%
|
2.3
1.6%
|
| Title | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 71 | 45 | 44 | 126 | 23 | 34 | 125 |
| Did not answer this question |
1.7
1.2%
|
4.2
16.2%
|
7.0
8.6%
|
0
0%
|
0
0%
|
2.4
1.7%
|
0
0%
|
5.9
16.9%
|
1.6
1.1%
|
| Yes |
92.4
65.5%
|
95.8
368.5%
|
93.0
114.8%
|
100
178.6%
|
97.7
177.6%
|
96.0
69.1%
|
95.7
416.1%
|
94.1
268.9%
|
96.8
68.2%
|
| No |
5.9
4.2%
|
0
0%
|
0
0%
|
0
0%
|
2.3
4.2%
|
1.6
1.2%
|
4.3
18.7%
|
0
0%
|
1.6
1.1%
|
| Title | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) |
|---|---|
| Description | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 110 | 23 | 63 | 46 | 42 | 113 | 23 | 0 | 124 |
| Did not answer this question |
0.9
0.6%
|
4.3
16.5%
|
11.1
13.7%
|
2.2
3.9%
|
0
0%
|
0.9
0.6%
|
0
0%
|
2.4
6.9%
|
|
| Yes |
90.9
64.5%
|
95.7
368.1%
|
87.3
107.8%
|
93.5
167%
|
95.2
173.1%
|
92.0
66.2%
|
95.7
416.1%
|
94.4
269.7%
|
|
| No |
8.2
5.8%
|
0
0%
|
1.6
2%
|
4.3
7.7%
|
4.8
8.7%
|
7.1
5.1%
|
4.3
18.7%
|
3.2
9.1%
|
| Title | Wong-Baker Faces Pain Scale at 3 Months Post Procedure |
|---|---|
| Description | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure |
| Time Frame | baseline and 3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 134 | 25 | 77 | 37 | 38 | 123 | 23 | 33 | 131 |
| Mean level of pain per WBPS at baseline |
1.9
(2.5)
1.3%
|
2.0
(2.2)
7.7%
|
1.5
(1.8)
1.9%
|
1.2
(2.2)
2.1%
|
1.6
(2.2)
2.9%
|
1.7
(2.0)
1.2%
|
2.2
(2.8)
9.6%
|
1.2
(1.5)
3.4%
|
1.4
(2.0)
1%
|
| Mean level of pain per WBPS at 3 months post-op |
0.5
(1.0)
0.4%
|
0.2
(0.6)
0.8%
|
0.9
(1.5)
1.1%
|
0.2
(0.6)
0.4%
|
0.2
(0.6)
0.4%
|
0.3
(0.9)
0.2%
|
0.4
(0.8)
1.7%
|
0.4
(1.0)
1.1%
|
0.5
(1.2)
0.4%
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
|---|---|
| Description | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 62 | 9 | 22 | 15 | 15 | 48 | 9 | 18 | 48 |
| PISQ-12 mean score at baseline |
33.4
(7.3)
23.7%
|
31.7
(5.4)
121.9%
|
35.3
(5.3)
43.6%
|
32.8
(5.5)
58.6%
|
33.0
(6.2)
60%
|
34.1
(6.1)
24.5%
|
34.3
(4.5)
149.1%
|
33.4
(4.8)
95.4%
|
31.9
(8.4)
22.5%
|
| PISQ-12 mean score at 12M |
37.2
(5.9)
26.4%
|
33.8
(9.3)
130%
|
36.3
(4.9)
44.8%
|
34.9
(5.6)
62.3%
|
36.4
(5.8)
66.2%
|
36.5
(5.5)
26.3%
|
35.6
(5.5)
154.8%
|
37.7
(5.8)
107.7%
|
37.4
(5.7)
26.3%
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 |
|---|---|
| Description | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 56 | 9 | 22 | 16 | 13 | 37 | 8 | 0 | 45 |
| PISQ-12 mean score at baseline |
32.4
(7.4)
23%
|
31.7
(5.4)
121.9%
|
34.5
(6.5)
42.6%
|
32.4
(5.3)
57.9%
|
31.9
(5.2)
58%
|
34.9
(5.8)
25.1%
|
33.6
(4.2)
146.1%
|
32.0
(8.4)
91.4%
|
|
| PISQ-12 mean score at 24M |
36.9
(6.4)
26.2%
|
36.6
(5.3)
140.8%
|
36.0
(4.4)
44.4%
|
35.3
(4.6)
63%
|
35.9
(4.8)
65.3%
|
36.6
(6.5)
26.3%
|
34.6
(5.5)
150.4%
|
36.3
(6.1)
103.7%
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. . |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 124 | 25 | 65 | 47 | 45 | 123 | 23 | 30 | 127 |
| PFIQ-7 mean score at baseline |
70.4
(72.2)
49.9%
|
68.2
(62.8)
262.3%
|
54.9
(55.7)
67.8%
|
61.5
(75.7)
109.8%
|
58.9
(70.1)
107.1%
|
65.4
(59.8)
47.1%
|
60.2
(40.0)
261.7%
|
71.4
(67.2)
204%
|
59.8
(61.1)
42.1%
|
| PFIQ-7 mean score at 6M |
16.3
(35.7)
11.6%
|
21.7
(44.0)
83.5%
|
9.9
(21.1)
12.2%
|
8.4
(20.5)
15%
|
9.2
(28.3)
16.7%
|
22.3
(40.8)
16%
|
6.0
(13.6)
26.1%
|
22.8
(36.5)
65.1%
|
12.9
(29.0)
9.1%
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 117 | 22 | 67 | 45 | 42 | 120 | 23 | 28 | 122 |
| PFIQ-7 mean score at baseline |
64.9
(70.5)
46%
|
59.3
(48.2)
228.1%
|
59.1
(57.4)
73%
|
61.7
(74.6)
110.2%
|
57.5
(65.0)
104.5%
|
65.6
(59.7)
47.2%
|
60.2
(40.0)
261.7%
|
73.0
(68.1)
208.6%
|
55.8
(60.5)
39.3%
|
| PFIQ-7 mean score at 12M |
13.1
(27.8)
9.3%
|
10.0
(19.8)
38.5%
|
9.1
(16.0)
11.2%
|
10.7
(21.8)
19.1%
|
8.8
(26.7)
16%
|
17.9
(39.9)
12.9%
|
8.5
(17.3)
37%
|
8.7
(13.6)
24.9%
|
14.0
(39.0)
9.9%
|
| Title | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 108 | 21 | 55 | 45 | 41 | 108 | 23 | 0 | 121 |
| PFIQ-7 mean score at baseline |
59.1
(63.8)
41.9%
|
55.6
(46.0)
213.8%
|
60.9
(59.3)
75.2%
|
56.5
(71.6)
100.9%
|
59.0
(69.5)
107.3%
|
64.3
(56.5)
46.3%
|
60.2
(40.0)
261.7%
|
54.8
(56.1)
156.6%
|
|
| PFIQ-7 mean score at 24M |
15.8
(40.9)
11.2%
|
5.0
(8.0)
19.2%
|
11.9
(27.8)
14.7%
|
10.5
(36.1)
18.8%
|
7.8
(23.4)
14.2%
|
17.9
(34.7)
12.9%
|
9.7
(15.0)
42.2%
|
9.3
(24.8)
26.6%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M |
|---|---|
| Description | Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 128 | 26 | 64 | 46 | 45 | 130 | 23 | 34 | 130 |
| PFDI- UDI mean score at baseline |
98.4
(59.6)
|
106.7
(63.4)
|
65.5
(34.5)
|
93.2
(55.1)
|
93.0
(55.0)
|
97.6
(59.8)
|
83.0
(40.4)
|
75.5
(54.2)
|
87.0
(55.5)
|
| PFDI- UDI mean score at 6M |
29.1
(37.2)
|
36.4
(38.4)
|
15.4
(19.1)
|
21.8
(22.4)
|
29.2
(37.7)
|
31.2
(35.6)
|
14.6
(23.4)
|
29.7
(33.5)
|
23.2
(27.2)
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 63 | 45 | 44 | 126 | 23 | 34 | 125 |
| PFDI- UDI mean score at baseline |
97.5
(59.1)
69.1%
|
103.6
(53.1)
398.5%
|
66.7
(33.7)
82.3%
|
92.4
(51.7)
165%
|
93.4
(54.4)
169.8%
|
97.6
(58.6)
70.2%
|
83.0
(40.4)
360.9%
|
75.5
(54.2)
215.7%
|
84.4
(50.8)
59.4%
|
| PFDI- UDI mean score at 12M |
34.8
(44.3)
24.7%
|
28.3
(40.7)
108.8%
|
14.0
(14.6)
17.3%
|
22.8
(25.4)
40.7%
|
20.3
(28.9)
36.9%
|
33.0
(36.5)
23.7%
|
19.8
(22.6)
86.1%
|
26.4
(30.8)
75.4%
|
21.0
(28.1)
14.8%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 110 | 22 | 55 | 45 | 42 | 113 | 23 | 0 | 124 |
| PFDI- UDI mean score at baseline |
96.5
(56.7)
68.4%
|
94.9
(55.8)
365%
|
69.9
(34.5)
86.3%
|
89.6
(51.5)
160%
|
95.8
(56.9)
174.2%
|
97.6
(57.1)
70.2%
|
83.0
(40.4)
360.9%
|
82.5
(50.6)
235.7%
|
|
| PFDI- UDI mean score at 24M |
28.1
(35.7)
19.9%
|
13.2
(17.1)
50.8%
|
19.8
(22.7)
24.4%
|
20.3
(21.8)
36.3%
|
29.8
(39.1)
54.2%
|
29.4
(30.9)
21.2%
|
15.1
(14.1)
65.7%
|
20.5
(25.0)
58.6%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 127 | 26 | 63 | 47 | 46 | 130 | 23 | 34 | 130 |
| PFDI- POPDI mean score at baseline |
137.0
(69.9)
97.2%
|
128.9
(65.9)
495.8%
|
102.3
(45.4)
126.3%
|
112.0
(67.2)
200%
|
115.7
(69.9)
210.4%
|
122.7
(64.3)
88.3%
|
115.5
(53.5)
502.2%
|
105.4
(61.3)
301.1%
|
107.8
(65.9)
75.9%
|
| PFDI- POPDI mean score at 6M |
37.5
(43.4)
26.6%
|
34.7
(48.8)
133.5%
|
27.8
(34.8)
34.3%
|
19.1
(21.9)
34.1%
|
30.3
(35.2)
55.1%
|
42.9
(50.9)
30.9%
|
21.6
(24.4)
93.9%
|
36.1
(48.3)
103.1%
|
31.8
(40.7)
22.4%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 127 | 26 | 63 | 46 | 45 | 128 | 23 | 33 | 128 |
| PFDI- CRADI mean score at baseline |
129.6
(88.1)
91.9%
|
125.8
(83.3)
483.8%
|
52.6
(48.3)
64.9%
|
82.4
(75.1)
147.1%
|
94.1
(71.8)
171.1%
|
110.0
(74.0)
79.1%
|
102.1
(65.9)
443.9%
|
70.5
(60.7)
201.4%
|
80.6
(68.1)
56.8%
|
| PFDI- CRADI mean score at 6M |
49.2
(63.1)
34.9%
|
45.3
(42.6)
174.2%
|
30.6
(38.9)
37.8%
|
23.4
(28.3)
41.8%
|
31.2
(36.5)
56.7%
|
52.9
(62.5)
38.1%
|
29.0
(35.6)
126.1%
|
41.8
(44.1)
119.4%
|
36.3
(46.5)
25.6%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 62 | 45 | 44 | 126 | 23 | 34 | 124 |
| PFDI- POPDI mean score at baseline |
135.1
(68.9)
95.8%
|
128.2
(55.4)
493.1%
|
103.3
(45.6)
127.5%
|
105.7
(58.8)
188.8%
|
116.1
(65.9)
211.1%
|
122.0
(63.7)
87.8%
|
115.5
(53.5)
502.2%
|
105.4
(61.3)
301.1%
|
104.4
(62.6)
73.5%
|
| PFDI- POPDI mean score at 12M |
45.2
(49.3)
32.1%
|
42.4
(50.5)
163.1%
|
25.8
(30.3)
31.9%
|
23.6
(30.3)
42.1%
|
19.9
(28.0)
36.2%
|
43.0
(52.5)
30.9%
|
29.9
(27.7)
130%
|
32.5
(34.2)
92.9%
|
23.8
(36.5)
16.8%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IVmodels | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 109 | 22 | 54 | 45 | 42 | 113 | 23 | 0 | 124 |
| PFDI- POPDI mean score at baseline |
132.4
(68.3)
93.9%
|
113.2
(56.6)
435.4%
|
107.4
(46.3)
132.6%
|
104.7
(60.1)
187%
|
116.1
(65.1)
211.1%
|
121.7
(63.0)
87.6%
|
115.5
(53.5)
502.2%
|
103.3
(59.1)
295.1%
|
|
| PFDI- POPDI mean score at 24M |
36.4
(48.9)
25.8%
|
13.8
(18.1)
53.1%
|
31.7
(37.6)
39.1%
|
23.8
(28.1)
42.5%
|
31.1
(36.7)
56.5%
|
37.6
(51.9)
27.1%
|
21.9
(21.6)
95.2%
|
24.8
(32.3)
70.9%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 119 | 24 | 63 | 44 | 43 | 126 | 23 | 33 | 121 |
| PFDI- CRADI mean score at baseline |
129.8
(88.9)
92.1%
|
123.5
(73.8)
475%
|
50.9
(49.3)
62.8%
|
85.1
(72.3)
152%
|
100.8
(72.8)
183.3%
|
108.2
(71.7)
77.8%
|
102.1
(65.9)
443.9%
|
70.5
(60.7)
201.4%
|
77.2
(66.9)
54.4%
|
| PFDI- CRADI mean score at 12M |
46.6
(60.5)
33%
|
47.3
(51.2)
181.9%
|
27.3
(36.2)
33.7%
|
29.9
(42.1)
53.4%
|
22.7
(30.6)
41.3%
|
49.6
(55.1)
35.7%
|
32.5
(41.0)
141.3%
|
39.4
(42.8)
112.6%
|
29.4
(44.7)
20.7%
|
| Title | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M |
|---|---|
| Description | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Time Frame | baseline and 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 109 | 22 | 54 | 45 | 42 | 112 | 23 | 0 | 122 |
| PFDI- CRADI mean score at baseline |
126.9
(84.9)
90%
|
110.6
(73.2)
425.4%
|
58.3
(50.4)
72%
|
79.8
(73.2)
142.5%
|
95.5
(74.3)
173.6%
|
105.9
(70.3)
76.2%
|
102.1
(65.9)
443.9%
|
77.2
(65.2)
220.6%
|
|
| PFDI- CRADI mean score at 24M |
40.2
(53.5)
28.5%
|
22.0
(30.6)
84.6%
|
33.7
(41.3)
41.6%
|
25.1
(38.5)
44.8%
|
27.2
(37.8)
49.5%
|
42.7
(52.7)
30.7%
|
29.4
(36.7)
127.8%
|
28.9
(35.3)
82.6%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure |
|---|---|
| Description | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with uterine descent >=stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 36 | 7 | 0 | 0 | 7 | 37 | 11 | 30 | 73 |
| Number (95% Confidence Interval) [percentage of participant] |
86.1
|
100
|
100
|
89.2
|
90.9
|
90.0
|
95.9
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure |
|---|---|
| Description | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 0 | 0 | 73 | 44 | 0 | 0 | 0 | 34 | 127 |
| Number (95% Confidence Interval) [percentage of participant] |
71.2
|
85.1
|
58.8
|
87.4
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 125 | 26 | 0 | 0 | 46 | 126 | 23 | 0 | 0 |
| Number (95% Confidence Interval) [percentage of participants] |
94.4
67%
|
100
384.6%
|
91.3
112.7%
|
96.8
172.9%
|
100
181.8%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 108 | 23 | 0 | 0 | 44 | 106 | 23 | 0 | 0 |
| Number (95% Confidence Interval) [percentage of participants] |
93.5
66.3%
|
95.7
368.1%
|
90.9
112.2%
|
91.5
163.4%
|
100
181.8%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with uterine descent >=stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 38 | 7 | 0 | 0 | 9 | 40 | 11 | 30 | 82 |
| Number (95% Confidence Interval) [Percentage of participants] |
94.7
67.2%
|
100
384.6%
|
100
123.5%
|
92.5
165.2%
|
90.9
165.3%
|
90.0
64.7%
|
98.8
429.6%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with uterine descent >=stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 32 | 6 | 0 | 0 | 7 | 34 | 11 | 0 | 79 |
| Number (95% Confidence Interval) [Percentage of participants] |
84.4
59.9%
|
100
384.6%
|
85.4
105.4%
|
88.2
157.5%
|
90.9
165.3%
|
96.2
69.2%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 0 | 0 | 73 | 47 | 0 | 0 | 0 | 34 | 131 |
| Number (95% Confidence Interval) [percentage of participants] |
76.7
54.4%
|
91.5
351.9%
|
61.8
76.3%
|
86.3
154.1%
|
| Title | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure |
|---|---|
| Description | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline |
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Measure Participants | 0 | 0 | 68 | 46 | 0 | 0 | 0 | 0 | 125 |
| Number (95% Confidence Interval) [Percentage of participants] |
69.1
49%
|
87.0
334.6%
|
81.6
100.7%
|
Adverse Events
| Time Frame | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel. | |||||||||||||||||
| Arm/Group Title | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | |||||||||
| Arm/Group Description | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) | |||||||||
All Cause Mortality |
||||||||||||||||||
| Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||||
Serious Adverse Events |
||||||||||||||||||
| Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/141 (7.1%) | 1/26 (3.8%) | 11/81 (13.6%) | 3/56 (5.4%) | 3/55 (5.5%) | 8/139 (5.8%) | 1/23 (4.3%) | 8/35 (22.9%) | 11/142 (7.7%) | |||||||||
| General disorders | ||||||||||||||||||
| any Serious Adverse Event | 10/141 (7.1%) | 10 | 1/26 (3.8%) | 1 | 11/81 (13.6%) | 11 | 3/56 (5.4%) | 3 | 3/55 (5.5%) | 3 | 8/139 (5.8%) | 8 | 1/23 (4.3%) | 1 | 8/35 (22.9%) | 8 | 11/142 (7.7%) | 11 |
Other (Not Including Serious) Adverse Events |
||||||||||||||||||
| Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | ||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/141 (21.3%) | 3/26 (11.5%) | 30/81 (37%) | 20/56 (35.7%) | 20/55 (36.4%) | 30/139 (21.6%) | 3/23 (13%) | 7/35 (20%) | 62/142 (43.7%) | |||||||||
| General disorders | ||||||||||||||||||
| Any non-serious adverse events | 30/141 (21.3%) | 3/26 (11.5%) | 30/81 (37%) | 20/56 (35.7%) | 20/55 (36.4%) | 30/139 (21.6%) | 3/23 (13%) | 7/35 (20%) | 62/142 (43.7%) | |||||||||
| Infections and infestations | ||||||||||||||||||
| Urinary Tract Infection | 2/141 (1.4%) | 2 | 0/26 (0%) | 0 | 5/81 (6.2%) | 5 | 4/56 (7.1%) | 4 | 3/55 (5.5%) | 3 | 2/139 (1.4%) | 2 | 1/23 (4.3%) | 1 | 0/35 (0%) | 0 | 8/142 (5.6%) | 9 |
| Infection- Vaginal | 1/141 (0.7%) | 1 | 0/26 (0%) | 0 | 0/81 (0%) | 0 | 2/56 (3.6%) | 2 | 4/55 (7.3%) | 4 | 2/139 (1.4%) | 2 | 0/23 (0%) | 0 | 0/35 (0%) | 0 | 1/142 (0.7%) | 1 |
| Nervous system disorders | ||||||||||||||||||
| Dyspareunia | 1/141 (0.7%) | 1 | 1/26 (3.8%) | 1 | 1/81 (1.2%) | 1 | 0/56 (0%) | 0 | 1/55 (1.8%) | 1 | 0/139 (0%) | 0 | 0/23 (0%) | 0 | 1/35 (2.9%) | 1 | 7/142 (4.9%) | 7 |
| Surgical and medical procedures | ||||||||||||||||||
| Device Malfunction | 2/141 (1.4%) | 2 | 0/26 (0%) | 0 | 0/81 (0%) | 0 | 3/56 (5.4%) | 3 | 1/55 (1.8%) | 1 | 0/139 (0%) | 0 | 0/23 (0%) | 0 | 0/35 (0%) | 0 | 0/142 (0%) | 0 |
Limitations/Caveats
Ph- II ended before all subjects reached 24M visit b/c the next generation of Perigee was already under trial, Ph-III/IV
Ph-VI ended after 12M visit because the next generation of study device was already under clinical evaluation in Phase VII
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. James C Lukban, Professor & Director Division of urogynecology |
|---|---|
| Organization | Eastern Virginia Medical School |
| Phone | 7574467900 |
| lukbanjc@evms.edu |
Responsible Party:
ASTORA Women's Health
ClinicalTrials.gov Identifier:
NCT00638235
Other Study ID Numbers:
- 1004
- NCT00793039
First Posted:
Mar 19, 2008
Last Update Posted:
Oct 28, 2016
Last Verified:
Sep 1, 2016