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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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106