Mesh check: 7-Year study tracks prolapse repair success
NCT ID NCT04829058
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study looks at how well a specific mesh (GYNEMESH PS) works for women who had surgery to fix pelvic organ prolapse. About 100 women will be checked roughly 7 years after their surgery to see if the repair is still successful. The goal is to gather long-term information on the mesh's performance and safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
64 people
The number who actually took part.
- Started
-
Nov 2021
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Female subjects ≥ 21 years of age: * with a baseline diagnosis of apical vaginal or uterine prolapse; * who had laparotomic or laparoscopic sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse within 7 years of enrolment; * where GYNEMESH PS Mesh was used as a bridging material, and; * who are willing and able to participate in prospective follow-up.
- Ages
-
21 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse 2. GYNEMESH PS Mesh was used as a bridging material according to the IFU. 3. Able and willing to participate in follow-up 4. 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: 1. Subjects \< 21 years of age at the time of informed consent 2. Subjects who had transvaginal approach for surgery 3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Pelvic organ prolapse are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, 19454, United States
-
UMPC
Pittsburgh, Pennsylvania, 15213, United States
-
Universitatsklinikum Tubingen
Tübingen, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a biological mesh improve pelvic floor surgery?
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- AI may predict which pelvic floor therapy works best
- Can a small pressure drop make prolapse surgery less painful?
- Could a simple surgical step make hysterectomies safer?