Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study
Peking Union Medical College Hospital
336 participants
Jun 29, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria1
- Women enrolled in previous RCT study
Exclusion Criteria2
- 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- Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator.
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Interventions
transvaginal mesh procedure using self-cut mesh
transvaginal mesh procedure using mesh-kit
Locations(11)
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NCT05938881