Efficacy Study of Vaginal Mesh for Prolapse (NCT00475540) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Study of Vaginal Mesh for Prolapse
United States65 participantsStarted 2007-01
Plain-language summary
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Woman \> 21 yrs
* Stage II-IV vaginal prolapse
* Desires vaginal reconstructive surgery
* Able to complete study questionnaires and assessments
* Uterus \< 12 weeks size
* Available for 12 months follow-up
Exclusion Criteria:
* Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
* Current intermittent catheterization.
* Pregnancy or desire for future fertility.
* Presence of an adnexal mass.
* Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).
* Other laparoscopic or abdominal/pelvic surgery in the past 3 months.
* Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury.
* Need for concomitant surgery requiring an abdominal incision.
* \< 12 months post-partum.
* Non-english speaking
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Anatomic Cure at 3 Years