Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems

Sponsor
Agustin Sampietro (Other)
Overall Status
Completed
CT.gov ID
NCT03715803
Collaborator
(none)
217
1
14.2
15.3

Study Details

Study Description

Brief Summary

The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft).

Condition or Disease Intervention/Treatment Phase
  • Device: Calistar A mesh to treat anterior and apical POP
  • Device: Calistar S mesh to treat anterior and apical POP

Detailed Description

The main objective of this study is to compare the initial outcomes and complication of two meshes implanted through a single incision to treat anterior and apical prolapses, Calistar A and a second-generation low weight mesh called Calistar S (Soft). In such sense, objective and subjective parameters will be retrospectively tested to demonstrate the safety and effectiveness of this products. Safety will be assessed by register of complications and effectiveness will be evaluated by pelvic floor reconstruction and quality of life improvements.

Study Design

Study Type:
Observational
Actual Enrollment :
217 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Calistar A vs. Calistar S - Cohort Retrospective Analysis
Actual Study Start Date :
Oct 25, 2018
Actual Primary Completion Date :
Aug 20, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Calistar A

Calistar A mesh to treat anterior and apical POP

Device: Calistar A mesh to treat anterior and apical POP
Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses

Calistar S

Calistar S mesh to treat anterior and apical POP

Device: Calistar S mesh to treat anterior and apical POP
Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses

Outcome Measures

Primary Outcome Measures

  1. Percentage of Cured Participants According to Barber Criteria [Post-operative at 6 months]

    According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.

Secondary Outcome Measures

  1. Percentage of Participants Cured According to Objective Measure (POP-Q Quantification) [Pre-operative and post-operative at 6 months]

    Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.

  2. Quality of Life Status: Patient Global Impression Questionnaire [Post-operative at 6 months]

    Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.

  3. Adverse Events [Intra-operative and post-operative at 6 months]

    Register of adverse events. Clavien-Dindo classification

Other Outcome Measures

  1. Quality of Life: PFDI 20 [Post-operative at 6 months]

    Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).

  2. Quality of Life: PISQ-12 [Post-operative at 6 months]

    Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Female

  • Anterior and apical prolapse Stage 3 (according to POP-Q) or more with or without stress urinary incontinence (SUI)

  • Primary or recurrent treatment with Calistar S or Calistar A

  • At least 6 months follow-up

Exclusion Criteria:
  • Recurrent vaginal infections,

  • Chronic colorectal diseases (chronic nonspecific ulcerative colitis, diverticulitis, diverticulosis, Chron's disease, irritable bowel syndrome, familial polyposis).

  • Presence of any coagulopathies,

  • Impairment of the immune system or any condition that compromises recovery,

  • Prior irradiation

  • Chronic pelvic pain

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Británico Buenos Aires Argentina C1280AEB

Sponsors and Collaborators

  • Agustin Sampietro

Investigators

  • Principal Investigator: Agustín Sampietro, Dr, Faculty of Medicine, University of Buenos Aires

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Agustin Sampietro, Gynecologist, University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT03715803
Other Study ID Numbers:
  • CaSCaA
First Posted:
Oct 23, 2018
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Period Title: Overall Study
STARTED 91 126
COMPLETED 91 126
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Calistar A Calistar S Total
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses Total of all reporting groups
Overall Participants 91 126 217
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
62
(9)
62
(8)
62
(8)
Sex: Female, Male (Count of Participants)
Female
91
100%
126
100%
217
100%
Male
0
0%
0
0%
0
0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (Count of Participants)
Argentina
32
35.2%
71
56.3%
103
47.5%
Brazil
23
25.3%
19
15.1%
42
19.4%
Italy
29
31.9%
30
23.8%
59
27.2%
France
7
7.7%
6
4.8%
13
6%

Outcome Measures

1. Primary Outcome
Title Percentage of Cured Participants According to Barber Criteria
Description According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.
Time Frame Post-operative at 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 91 126
Number [percentage of cured patients]
82.42
90.48
2. Secondary Outcome
Title Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)
Description Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.
Time Frame Pre-operative and post-operative at 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 91 126
Number [percentage of cured patients]
82.42
88.88
3. Secondary Outcome
Title Quality of Life Status: Patient Global Impression Questionnaire
Description Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.
Time Frame Post-operative at 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 91 126
Median (Full Range) [units on a scale]
5
5
4. Secondary Outcome
Title Adverse Events
Description Register of adverse events. Clavien-Dindo classification
Time Frame Intra-operative and post-operative at 6 months

Outcome Measure Data

Analysis Population Description
Adverse events were presented in a separate section.
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 0 0
5. Other Pre-specified Outcome
Title Quality of Life: PFDI 20
Description Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).
Time Frame Post-operative at 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 91 126
Median (Full Range) [score on a scale]
30.85
19.4
6. Other Pre-specified Outcome
Title Quality of Life: PISQ-12
Description Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.
Time Frame Post-operative at 6 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Measure Participants 91 126
Median (Full Range) [score on a scale]
0
0

Adverse Events

Time Frame All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
Adverse Event Reporting Description
Arm/Group Title Calistar A Calistar S
Arm/Group Description Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
All Cause Mortality
Calistar A Calistar S
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/91 (0%) 0/126 (0%)
Serious Adverse Events
Calistar A Calistar S
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/91 (0%) 0/126 (0%)
Other (Not Including Serious) Adverse Events
Calistar A Calistar S
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 30/91 (33%) 14/126 (11.1%)
Renal and urinary disorders
Urinary tract infection 12/91 (13.2%) 12 1/126 (0.8%) 1
Surgical and medical procedures
Pain 6/91 (6.6%) 6 6/126 (4.8%) 6
Reoperation for prolapse 2/91 (2.2%) 2 2/126 (1.6%) 2
Mesh erosion 10/91 (11%) 10 5/126 (4%) 5

Limitations/Caveats

Retrospective study; CaA procedures started a long time before the first CaS cases (Ca S level of surgeon training more experienced). Available data only enables mid-term follow-ups of differing duration's between the two groups.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Agustín Sampietro
Organization Universidad de Buenos Aires
Phone +5491158336327
Email asampietro@live.com.ar
Responsible Party:
Agustin Sampietro, Gynecologist, University of Buenos Aires
ClinicalTrials.gov Identifier:
NCT03715803
Other Study ID Numbers:
  • CaSCaA
First Posted:
Oct 23, 2018
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020