POWER1012: Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
Study Details
Study Description
Brief Summary
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.
The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 AMS Prolapse Product (AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family) |
Device: AMS Prolapse Product
AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device [up to 2-years post-implant]
Secondary Outcome Measures
- Prolapse Efficacy Success Rate [24 months]
Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female at least 21 years old
-
Has pelvic organ prolapse requiring surgical repair
-
Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse
Exclusion Criteria:
- Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samuel Zylstra, MD | Whitinsville | Massachusetts | United States | 01588 |
Sponsors and Collaborators
- ASTORA Women's Health
Investigators
- Principal Investigator: Samuel Zylstra, MD, Whitinsville Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1012
Study Results
Participant Flow
| Recruitment Details | The first patient was registered in September 2006, The last patient data were entered in May 2010. |
|---|---|
| Pre-assignment Detail | Patients had to met all of the inclusion criteria and none of the exclusion criteria. |
| Arm/Group Title | 1 - Any AMS Prolapse Product |
|---|---|
| Arm/Group Description | at least one AMS prolapse product was used |
| Period Title: Overall Study | |
| STARTED | 1590 |
| COMPLETED | 1543 |
| NOT COMPLETED | 47 |
Baseline Characteristics
| Arm/Group Title | 1 - Any AMS Prolapse Product |
|---|---|
| Arm/Group Description | at least one AMS prolapse product was used |
| Overall Participants | 1590 |
| Age (participants) [Mean (Standard Deviation) ] | |
| Age <89 years |
62
(12)
3.9%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1590
100%
|
| Male |
0
0%
|
Outcome Measures
| Title | Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device |
|---|---|
| Description | |
| Time Frame | up to 2-years post-implant |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients that met the inclusion/exclusion criteria. |
| Arm/Group Title | 1 - Any AMS Prolapse Product |
|---|---|
| Arm/Group Description | at least one AMS prolapse product was used |
| Measure Participants | 1543 |
| Number [participants] |
194
12.2%
|
| Title | Prolapse Efficacy Success Rate |
|---|---|
| Description | Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used. |
| Time Frame | 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients returning for a visit between 19-24 months post-procedure. |
| Arm/Group Title | 1 - Any AMS Prolapse Product |
|---|---|
| Arm/Group Description | at least one AMS prolapse product was used |
| Measure Participants | 332 |
| Number (95% Confidence Interval) [percentage of participants] |
81.6
5.1%
|
Adverse Events
| Time Frame | 2 years | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | 1 - Any AMS Prolapse Product | |
| Arm/Group Description | at least one AMS prolapse product was used | |
All Cause Mortality |
||
| 1 - Any AMS Prolapse Product | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| 1 - Any AMS Prolapse Product | ||
| Affected / at Risk (%) | # Events | |
| Total | 71/1543 (4.6%) | |
| Gastrointestinal disorders | ||
| Constipation | 2/1543 (0.1%) | 2 |
| General disorders | ||
| Extrusion | 24/1543 (1.6%) | 26 |
| Other Genitourinary | 2/1543 (0.1%) | 2 |
| Pain - dyspareunia | 2/1543 (0.1%) | 2 |
| Pain - excluding dyspareunia | 3/1543 (0.2%) | 3 |
| Wound separation <3 months post-op | 3/1543 (0.2%) | 3 |
| Infections and infestations | ||
| Infection | 1/1543 (0.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Hematoma | 1/1543 (0.1%) | 1 |
| Perforation - bladder | 5/1543 (0.3%) | 5 |
| Musculoskeletal and connective tissue disorders | ||
| Adhesion | 1/1543 (0.1%) | 1 |
| Renal and urinary disorders | ||
| Incontinence | 6/1543 (0.4%) | 6 |
| Urinary retention | 1/1543 (0.1%) | 1 |
| Urinary urge, frequency, or hesistancy | 2/1543 (0.1%) | 2 |
| Reproductive system and breast disorders | ||
| Prolapse | 14/1543 (0.9%) | 14 |
| Skin and subcutaneous tissue disorders | ||
| Granuloma formation | 2/1543 (0.1%) | 2 |
| Surgical and medical procedures | ||
| Dehiscence at vaginal suture line before healing occurs | 2/1543 (0.1%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| 1 - Any AMS Prolapse Product | ||
| Affected / at Risk (%) | # Events | |
| Total | 138/1543 (8.9%) | |
| General disorders | ||
| extrusion | 30/1543 (1.9%) | 32 |
| pain (excluding dyspareunia) | 15/1543 (1%) | 15 |
| Infections and infestations | ||
| infection | 13/1543 (0.8%) | 14 |
| Renal and urinary disorders | ||
| incontinence | 12/1543 (0.8%) | 12 |
| Reproductive system and breast disorders | ||
| prolapse | 40/1543 (2.6%) | 41 |
| Skin and subcutaneous tissue disorders | ||
| granuloma formation | 11/1543 (0.7%) | 11 |
| other events below threshold | 28/1543 (1.8%) | 28 |
| Surgical and medical procedures | ||
| hematoma | 10/1543 (0.6%) | 10 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AMS (sponsor) is the sole owner of the conglomerate data inputted into the POWER database and has the right to publish such data at its sole discretion. Registry Physician will provide AMS with a copy of any data, finding, result, article, abstract, manuscripts, presentation, or other information intended for publication, at least thirty (30) days prior to submission of same for publication.
Results Point of Contact
| Name/Title | Dr Samuel Zylstra |
|---|---|
| Organization | Whitinsville Medical Center |
| Phone | 508-243-6260 |
| samuelzylstra@milreg.org |
- 1012