Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Running, not enrolling · Not applicable

Conditions studied: Uterine Prolapse

In brief

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.

Key facts

Study ID

NCT05063331

Run by

University Hospitals Cleveland Medical Center

People needed

300

Starts

2021-12-15

Expected to finish

2029-05-31

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women ≥ 18 years of age and ≤ 80 years of age
• Have diagnosis of symptomatic uterovaginal prolapse
• Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
• Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

You may not qualify if…

• Patients who wish to undergo uterine sparing procedures
• Body mass index BMI) > 50
• Previous hysterectomy or prior uterovaginal surgery
• Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
• Chronic indwelling urinary catheter
• Urinary diversion of any type
• Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
• Unable to speak, read, understand English

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States
• Northwestern Medicine — Chicago, Illinois, United States
• Duke University — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh, UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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