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Recruiting NCT05063331

Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Trial Parameters

Condition Uterine Prolapse
Sponsor University Hospitals Cleveland Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 320
Sex FEMALE
Min Age 18 Years
Max Age 80 Years
Start Date 2021-12-15
Completion 2030-07-31
Interventions
Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Women ≥ 18 years of age and ≤ 80 years of age 2. Have diagnosis of symptomatic uterovaginal prolapse 3. Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician 4. 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: 1. Patients who wish to undergo uterine sparing procedures 2. Body mass index BMI) \> 50 3. Previous hysterectomy or prior uterovaginal surgery 4. Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident 5. Chronic indwelling urinary catheter 6. Urinary diversion of any type 7. 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 8. Unable to speak, read, unders

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