Actively Recruiting
BELIEVE Trial: Bulking Versus Sling for Treating Stress Urinary Incontinence at the Time of Vaginal Prolapse Repair
Led by University Hospitals Cleveland Medical Center · Updated on 2026-06-01
476
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
K
Kaiser Permanente
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two surgical treatments for stress urinary incontinence (SUI) in women undergoing pelvic organ prolapse repair. The study aims to determine which procedure, retropubic midurethral sling (RP-MUS) or urethral bulking with polyacrylamide hydrogel (PAHG), leads to better patient-reported outcomes and fewer complications over 24 months. This is a double-blinded, randomized trial designed to evaluate patient satisfaction and long-term effects of these treatments. Participants will be randomly assigned to receive either the RP-MUS, a minimally invasive tape placement surgery through the retropubic space, or the PAHG injection, which involves injecting a bulking agent into the urethra along with sham incisions to maintain blinding. Pelvic organ prolapse will be repaired using native tissue only, and patients will remain blinded to treatment unless complications arise. The study includes six visits over two years, with symptom questionnaires and occasional interviews for selected participants. During the study, participants will complete validated symptom questionnaires before surgery and at 1, 6, 12, and 24 months afterward to assess urinary symptoms, sexual function, and quality of life. Researchers will monitor retreatment rates, pelvic organ prolapse recurrence, and surgical complications. Some participants will take part in interviews at multiple timepoints to share their experiences. The trial will collect data continuously for two years to evaluate both short- and long-term outcomes and patient satisfaction.
CONDITIONS
Brief Title
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Diagnosis of symptomatic or occult stress urinary incontinence documented in medical records
- Positive testing for stress urinary incontinence via cough stress test or urodynamic testing
- Planning and eligible for native tissue pelvic organ prolapse repair and for both retropubic midurethral sling and polyacrylamide hydrogel procedures
You will not qualify if you...
- Undergoing pelvic organ prolapse repair with mesh or biologic augmentation other than own tissue
- Expected difficulty completing 24-month follow-up
- Anticipating pregnancy within 24 months or less than 18 months postpartum
- Hemoglobin A1c greater than 10.0% in the past 3 months
- Current smoker of more than 1 pack per week
- History of neurogenic bladder
- Current use of any catheter including intermittent, indwelling Foley, or suprapubic catheter
- Post-void residual volume greater than 150 mL not caused by prolapse obstruction
- Prior anti-incontinence procedures such as synthetic sling, fascial sling, Burch colposuspension, or urethral bulking
- Previous pelvic radiation therapy
- Planned concurrent procedure at time of prolapse repair
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo either a retropubic midurethral sling procedure or urethral bulking with polyacrylamide hydrogel, both performed at the time of vaginal prolapse repair.
1 surgical visit (in-person)
Duration - Up to 24 months postoperatively
Participants complete symptom questionnaires and assessments to monitor recovery, improvement, and any retreatment needs after surgery.
Visits at 1 month, 6 months, 12 months, and 24 months post-surgery (in-person or phone)
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
E
Elisar Khawam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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