Comparing two treatments for stress urinary incontinence in women

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 multicentered, double-blind, randomized controlled trial aims to compare the effectiveness of a transurethral bulking agent (TBA) and a single-incision sling (SIS) in treating women with stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI). A total of 358 women will be randomly assigned to receive either treatment, with their outcomes assessed at multiple follow-up points over three years. The primary outcome will be measured by patient-reported improvement in symptoms at 12 months, while secondary outcomes will include retreatment rates, objective measures of improvement, and quality of life assessments. Both interventions are FDA-approved and will be administered according to their approved uses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women ≥ 21 years
* For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required.
* A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months.
* Normal PVR \< 150 mL
* Candidate for either study procedure as determined by treating surgeon
* Available for up to 3 years.
* Agrees to randomization.

Exclusion Criteria:

* Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ)
* Urge-predominant mixed UI despite stable therapy
* Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment.
* Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.
* Malignancy or history of radiation of the pelvis
* Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year
* Incomplete emptying (PVR \> 150mL)
* Prior anti-incontinence procedure
* Neurogenic bladder
* Unwilling to continue current UUI treatment until completion of primary outcome at 12 months
* Prior adverse reaction to synthetic mesh or urethral bulking material
* Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.)
* Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.

Where it's running

• University of California at San Diego
  La Jolla, California, United States Recruiting
• Kaiser Permanente -- San Diego
  San Diego, California, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
  Durham, North Carolina, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Emily Lukacz, MD — University of California, San Diego

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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.