Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Purpose
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.
Condition
- Uterine Prolapse
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The study is utilizing a 1:1 randomization scheme (by site) to assign patients to one of two treatment arms: 1) minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP, N=160) or 2) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS, N=160).
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- Masking Description
- Participants will be masked to the surgical randomization prior to surgery and will be informed of their surgical assignment (unmasked) after waking up from surgery and prior to discharge.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Sacrocolpopexy |
Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) |
|
|
Active Comparator Uterosacral Ligament Suspension |
Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) |
|
Recruiting Locations
Cleveland, Ohio 44109
More Details
- Status
- Recruiting
- Sponsor
- University Hospitals Cleveland Medical Center
Detailed Description
This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse 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.