Active — Not RecruitingNot Applicable

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

United States300 participantsStarted 2021-12-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Treatment failure

Timeframe: 36 months post-surgery

Trial details

NCT IDNCT05063331

SponsorUniversity Hospitals Cleveland Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2038-05-31

View on ClinicalTrials.gov More Uterine Prolapse trials