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BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Sponsor: University Hospitals Cleveland Medical Center
Summary
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.
Official title: BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
476
Start Date
2025-05-01
Completion Date
2029-04
Last Updated
2025-05-06
Healthy Volunteers
No
Interventions
RP-MUS
a standard urethral sling placement for treatment of stress urinary incontinence
PAHG
A standard 2 mL dose injection of bulkamid (order and number will be at the discretion of the surgeon) will be given. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites.
Locations (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States