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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Elisar.Khawam@UHhospitals.org
• Phone: 216-844-2493

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.