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

Study acronym: BELIEVE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Collaborators: 10 to 11v4
  2. Collaborators: 11 to 10
    • Eligibility criteria expanded, about 3 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2025 to May 1, 2025
    • Interventions: PAHG (Procedure), RP-MUS (Procedure) to PAHG (Procedure), RP-MUS (Device)
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06754046
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: Kaiser Permanente, Duke University, Patient-Centered Outcomes Research Institute, University of California, San Diego, University of California, Irvine, MetroHealth Medical Center, Ohio State University, Northwestern University, University of New Mexico, Medstar Health Research Institute, University of Michigan
Conditions
(from sponsor)		 Stress Urinary Incontinence, Vaginal Prolapse
Related terms Urinary Incontinence, Stress, Uterine Prolapse
Enrollment 476 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov