Comparing two procedures for treating stress urinary incontinence during vaginal prolapse repair

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

This study is testing whether a new type of surgery or an injection is better for helping women with stress urinary incontinence during vaginal prolapse repair.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 476 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Hospitals Cleveland Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06754046 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine whether retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) is more effective for treating stress urinary incontinence (SUI) in women undergoing vaginal prolapse repair. Participants will be randomly assigned to one of the two procedures and will complete validated questionnaires at multiple time points over a 24-month period to assess their symptoms and quality of life. The study will also evaluate the complication rates and long-term outcomes associated with each procedure. Blinding will be maintained to ensure unbiased results, and qualitative interviews will be conducted with select participants to gather in-depth insights.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with a diagnosis of symptomatic stress urinary incontinence who are planning to undergo vaginal prolapse repair.

Not a fit: Patients who are undergoing pelvic organ prolapse repair using mesh or biologic augmentation, or those with certain medical conditions that may complicate the procedure, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a clearer understanding of the most effective treatment option for stress urinary incontinence during vaginal prolapse repair.

How similar studies have performed: Other studies have explored similar interventions for stress urinary incontinence, but this specific comparison of RP-MUS and PAHG is novel.

Eligibility criteria

Inclusion Criteria:

* Women ≥ 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.

Where this trial is running

Cleveland, Ohio

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: David Sheyn, MD — University Hospitals Cleveland Medical Center
• Study coordinator: Elisar Khawam

Conditions: Stress Urinary Incontinence, Vaginal Prolapse, midurethral sling, bulkamide, polyacrylamide hydrogel, urethral bulking, retropubic sling