IRB Study Number 21-1256
Status Recruiting
Locations A Building - Crile Building, Cleveland Clinic Main Campus, Fairview Hospital, Fairview Medical Office Building, Hillcrest Hospital, Hillcrest Medical Building Atrium, Medina Hospital, Medina Medical Office Building
Institute Obstetrics and Gynecology and Women's Health Institute
Description
This is a randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse who are scheduled to undergo surgery, will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women. Participants will receive parking validation (if applicable) and study stipend for their time to complete study visits.
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
