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

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

Who can join

Ages 18 and older · Women

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

About the 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.

What is being tested

• RP-MUS (device)
• PAHG (procedure)

Sponsor: University Hospitals Cleveland Medical Center · Participants: 476 · Started: May 1, 2025

Contact the study team

• Elisar Khawam · Phone: 216-844-2493

Official record on ClinicalTrials.gov — NCT06754046

Locations in the U.S.

Conditions

• Pelvic Floor Disorders

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.