GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Study Overview
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Brief Summary
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The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

Official Title
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A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse GYNEMESH PS Mesh was used as a bridging material according to the IFU. Able and willing to participate in follow-up Subject or authorized representative has signed the approved informed consent Exclusion Criteria Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: Subjects < 21 years of age at the time of informed consent Subjects who had transvaginal approach for surgery Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Intervention|There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange | Objective cure of vaginal or uterine prolapse approximately 7 years after surgery, defined as POP-Q stage ≤2 at point C as determined with physical exam. | Post-surgery through study completion, approximately 7 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Improvement (PGI-I) or Patient Global Impression of Change (PGI-C) Questionnaire |  | Post-surgery through study completion, approximately 7yrs | 
| Pelvic Floor Distress Inventory (PFDI-20) Questionnaire |  | Post-surgery through study completion, approximately 7yrs | 
| Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) or Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) |  | Post-surgery through study completion, approximately 7yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh, POP