Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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.
Conditions:
🦠 Uterine Prolapse
🗓️ Study Start (Actual) 15 December 2021
🗓️ Primary Completion (Estimated) 31 July 2030
✅ Study Completion (Estimated) 31 July 2030
👥 Enrollment (Estimated) 320
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Jacksonville, Florida, United States
📍 Durham, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 August 2021
  • First Submitted that Met QC Criteria 29 September 2021
  • First Posted 1 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 June 2024
  • Last Update Posted 1 July 2024
  • Last Verified June 2024