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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse — PREMIER  

Uterine Prolapse Clinical Trial

Official title:
Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

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-SCH+SCP) 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

Clinical Trial Details
NCT number NCT05063331
Study type Interventional
Source University Hospitals Cleveland Medical Center
Contact Christiana Mares
Phone 216-286-1094
Email Christiana.Mares@uhhospitals.org
Status Recruiting
Phase N/A
Start date December 15, 2021
Completion date June 30, 2030
View Details
See also
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