Actively Recruiting
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Led by University Hospitals Cleveland Medical Center · Updated on 2026-05-06
476
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
K
Kaiser Permanente
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.
CONDITIONS
Official Title
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Diagnosed with symptomatic or hidden stress urinary incontinence documented in medical records
- Positive stress urinary incontinence testing by cough stress test or urodynamic study
- Planned and eligible to undergo native tissue prolapse repair and both RP-MUS and PAHG treatments
You will not qualify if you...
- Pelvic organ prolapse repairs using mesh or biologic material other than the patient's own tissue
- Expected difficulty completing 24-month follow-up
- Pregnancy anticipated within 24 months or less than 18 months postpartum
- Hemoglobin A1c greater than 10% in past 3 months
- Current smoker of more than 1 pack per week
- History of neurogenic bladder
- Current catheter use of any kind
- Post-void residual urine greater than 150 mL not caused by prolapse obstruction
- Previous anti-incontinence surgery including synthetic or fascial slings, Burch colposuspension, or urethral bulking
- Prior pelvic radiation therapy
- Planned concurrent procedures during prolapse repair
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
E
Elisar Khawam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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