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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

Study acronym: BASIS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 364 wordsv9
  2. Primary completion pushed from Jan 1, 2028 to Dec 31, 2028
    • Study completion pushed from Jan 1, 2030 to Dec 31, 2030
    v8
  3. Site details revised at 1 of 7 sitesv7
  4. Primary completion date: Aug 1, 2027 to Jan 1, 2028
    • Study completion date: Aug 1, 2029 to Jan 1, 2030
    v6
  5. Primary completion date: Aug 2027 to Aug 1, 2027
    • Study completion date: Aug 2029 to Aug 1, 2029
    • Study sites revised (7)
    • Eligibility criteria expanded, about 1 word
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 2 of 7 sitesv4
  2. Site details revised at 2 of 7 sites
    • Collaborators reordered
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Jun 2027 to Aug 2027
    • Study completion date: Jun 2029 to Aug 2029
    • Start date changed from estimate of Jun 2024 to Aug 28, 2024
    • Study sites revised (7)
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).
Trial Details
NCT Number NCT06480227
Lead Sponsor NICHD Pelvic Floor Disorders Network
Collaborators: Duke University, Kaiser Permanente, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International, University of California, San Diego, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Stress Urinary Incontinence, Urinary Incontinence, Mixed Urinary Incontinence
Related terms Pelvic Floor Disorders, Urinary Incontinence, Urinary Incontinence, Stress
Enrollment 358 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov