Status:

RECRUITING

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

Lead Sponsor:

University Hospitals Cleveland Medical Center

Collaborating Sponsors:

University of Pittsburgh Medical Center

Kaiser Permanente

Conditions:

Stress Urinary Incontinence

Vaginal Prolapse

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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....

Detailed Description

This will be a double-blinded, non-inferiority, controlled trial utilizing a 1:1 randomization scheme to assign patients to each treatment arm (PAHG vs. RP-MUS). Patients undergoing PAHG will be given...

Eligibility Criteria

Inclusion Criteria:

  • Women ≥ 18 years of age.
  • Have diagnosis of symptomatic 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 vaginal 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.

Key Trial Info

Start Date :

May 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2029

Estimated Enrollment :

476 Patients enrolled

Trial Details

Trial ID

NCT06754046

Start Date

May 1 2025

End Date

April 1 2029

Last Update

May 6 2025

Active Locations (1)

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University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106