BELIEVE Trial Comparing Bulking Injection and Retropubic Midurethral Sling for Stress Urinary Incontinence During Vaginal Prolapse Repair

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.

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