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Long-term Success Rate of Transvaginal Mesh for the Treatment of Pelvic Organ Prolapse: The Extended RCT Study

NCT05938881 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 336

Last updated 2023-07-11

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

self-cut mesh procedure

transvaginal mesh procedure using self-cut mesh

PROCEDURE

mesh-kit procedure

transvaginal mesh procedure using mesh-kit

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Eligibility

Min Age
53 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2033-01-12
Completion
2033-03-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938881 on ClinicalTrials.gov