Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
Recruiting
Observational Study
Pelvic Organ Prolapse
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 53 – 75
- Sex
- Female
- Study type
- Observational
- Participants needed
- 336 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Other
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About This Trial
The original RCT trial is designed to compare self-tailored titanium-coated polypropylene mesh procedure with mesh-kit in the treatment of POP stage III-IV in terms of efficacy, safety and cost-effective at 1-year follow-up. This study will follow women in the original RCT study for up to 10 years from the time of the surgery to compare success and complication rates in the two groups. Recruitment…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Women enrolled in previous RCT study
Exclusion Criteria:
* Inability to provide informed consent. Informed consent will be obtained prior to each telephone interview and each in-person visit.
* Subjects who appear to have cognitive deficits during the in-person visit or site…
Contacts