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

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Dec 23, 2024

Keywords

ClinConnect Summary

The BELIEVE Trial is studying two different procedures to treat stress urinary incontinence (SUI) in women who are also having surgery for vaginal prolapse. The main goal of the trial is to find out which method—either a retropubic midurethral sling (a type of support for the bladder) or a bulking injection—works better for patients and causes fewer complications. Researchers will look at how patients feel about their treatment by using a questionnaire 24 months after surgery.

To participate in this trial, women must be at least 18 years old and have been diagnosed with SUI. They also need to be planning to have vaginal prolapse repair surgery and be eligible for both treatments being studied. Participants will be randomly assigned to one of the two procedures and will have six visits over two years to answer questions about their health and experiences. It’s important to note that some women will have the chance to share their thoughts in interviews at different times during the study. This trial is not yet recruiting participants, but it provides an opportunity for eligible women to contribute to important research on these treatments.

Gender

FEMALE

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 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.