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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Stress Urinary Incontinence, Vaginal Prolapse

In brief

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.

Key facts

Study ID

NCT06754046

Run by

University Hospitals Cleveland Medical Center

People needed

476

Starts

2025-05-01

Expected to finish

2029-04-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women ≥ 18 years of age.
• Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).
• Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing,
• Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)

You may not qualify if…

• Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue
• Patient anticipating difficulty with completing 24-month follow-up
• Anticipation of pregnancy within subsequent 24-months or <18 months post-partum
• Hemoglobin A1c >10.0% within the past 3-months
• Current smoker > 1 pack per week
• History of neurogenic bladder
• Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter
• Post-void residual >150 mL felt to not be due to obstruction for prolapse
• Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking
• Previous history of any pelvic radiation
• Patient receiving a planned concurrent procedure at the time of prolapse repair.

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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