Comparing two surgical options for uterovaginal prolapse

Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse

This study is testing two different surgeries for women with uterovaginal prolapse to see which one works better and is safer for recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 320 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: University Hospitals Cleveland Medical Center (other)
• Locations: 7 sites (Jacksonville, Florida and 6 other locations)
• Trial ID: NCT05063331 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness and safety of two surgical procedures for treating uterovaginal prolapse: a minimally invasive supracervical hysterectomy with sacrocolpopexy and a total vaginal hysterectomy with uterosacral ligament suspension. Women diagnosed with symptomatic uterovaginal prolapse will be randomly assigned to one of the two surgical approaches. Participants will be followed for three years, during which their recovery, satisfaction, and outcomes will be assessed through physical exams and validated questionnaires. Additionally, some participants will engage in interviews to provide deeper insights into their experiences and recovery.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 80 with a diagnosis of symptomatic uterovaginal prolapse who have chosen surgical management.

Not a fit: Patients who prefer uterine-sparing procedures or have certain medical conditions that disqualify them from the surgeries will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective surgical approach for treating uterovaginal prolapse, leading to improved patient outcomes and satisfaction.

How similar studies have performed: Other studies have explored surgical options for uterovaginal prolapse, but this specific comparison of these two techniques is relatively novel.

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

Where this trial is running

Jacksonville, Florida and 6 other locations

• Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
• Northwestern Medicine — Chicago, Illinois, United States (RECRUITING)
• Duke University — Durham, North Carolina, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• MetroHealth Medical Center — Cleveland, Ohio, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• University of Pittsburgh, UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Adonis Hijaz, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Grace Pelfrey

Conditions: Uterine Prolapse, Sacrocolpopexy, Uterosacral Ligament Suspension