Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Sep 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking to find out which of two surgical options works better for women with uterovaginal prolapse, a condition where the uterus drops into the vaginal canal. The researchers want to understand not just which surgery is more effective, but also which one has fewer complications in the short and long term from the perspective of the patients themselves.

To participate in this study, women need to be between 18 and 80 years old and have been diagnosed with symptomatic uterovaginal prolapse. They should be planning to have surgery and eligible for both types being compared: a minimally invasive procedure or a total vaginal hysterectomy with a specific support technique. Participants can expect to share their experiences and outcomes after surgery, helping to improve future treatment options for others. This trial is currently recruiting participants, so if you or someone you know fits the criteria, it could be a valuable opportunity to contribute to important research.

Gender

FEMALE

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, understand English