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

RecruitingNAAges 18 Years - anyFemaleUniversity Hospitals Cleveland Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women โ‰ฅ 18 years of age. * Have diagnosis of symptomatic or occult 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 native tissue 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.
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What it tests

  • RP-MUS
  • PAHG
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Where

1 site
University Hospitals Cleveland Medical Center
Cleveland, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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