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Study identifier: NCT06754046 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)

Condition: Stress Urinary Incontinence · Vaginal Prolapse  ·  Sponsor: University Hospitals Cleveland Medical Center

PhaseNA
Planned participants476
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Elisar Khawam  ·  216-844-2493  ·  Elisar.Khawam@UHhospitals.org

Always discuss trial participation with your own doctor first.

Locations (1)

University Hospitals Cleveland Medical CenterCleveland, Ohio, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06754046