Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
NCT ID: NCT05063331
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
320 participants
INTERVENTIONAL
2021-12-15
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sacrocolpopexy
Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)
Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
Uterosacral Ligament Suspension
Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
Interventions
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Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP)
Minimally invasive robotic or laparoscopic supracervical hysterectomy will be done, and the vaginal apex (including cervix) will be suspended utilizing sacrocolpopexy mesh to the anterior spinous ligament.
Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
The uterus will be removed vaginally and the vaginal apex will be suspended utilizing sutures in the uterosacral ligament.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
FEMALE
No
Sponsors
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Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
The Cleveland Clinic
OTHER
Duke University
OTHER
University of Pittsburgh
OTHER
Mayo Clinic
OTHER
Northwestern Medicine
OTHER
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Adonis Hijaz, MD
Professor of Urology
Principal Investigators
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Adonis Hijaz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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Mayo Clinic
Jacksonville, Florida, United States
Northwestern Medicine
Chicago, Illinois, United States
Duke University
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh, UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20210871
Identifier Type: -
Identifier Source: org_study_id