NCT05938881 Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
| NCT ID | NCT05938881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Pelvic Organ Prolapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 336 participants |
| Start Date | 2023-06-29 |
| Primary Completion | 2033-01-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 336 participants in total. It began in 2023-06-29 with a primary completion date of 2033-01-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 into this study is open only to women that already participated in previous RCT, no new treatment interventions will be given. Recruitment into the previous RCT is closed. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed.
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 * Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05938881 clinical trial?
This trial is open to female participants only, aged 53 Years or older, up to 75 Years, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05938881 currently recruiting?
Yes, NCT05938881 is actively recruiting participants. Contact the research team at zhu_julie@sina.com for enrollment information.
Where is the NCT05938881 trial being conducted?
This trial is being conducted at Foshan, China, Guangzhou, China, Changsha, China, Changsha, China and 7 additional locations.
Who is sponsoring the NCT05938881 clinical trial?
NCT05938881 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 336 participants.