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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
Exclusion Criteria
Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
Female subjects ≥ 21 years of age
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Female subjects ≥ 21 years of age:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Romanowski | Contact | 908-808-6219 | cromanow@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Martin Weisberg, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Female Pelvic Medicine | Recruiting | North Wales | Pennsylvania | 19454 | United States | |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 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 |
| UMPC |
| Recruiting |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Universitatsklinikum Tubingen | Recruiting | Tübingen | Germany |