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