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Clinical Trial Summary

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.

Clinical Trial Description

This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCP+SCH) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05063331
Study type Interventional
Source University Hospitals Cleveland Medical Center
Contact Ellen Divoky
Phone 216-368-5976
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date June 30, 2026

See also
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