NCT06480227

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (estimated)
• Sponsor: NICHD Pelvic Floor Disorders Network · Network
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The BASIS trial is a multicentered, double-blind, randomized controlled, surgical trial with two active interventions, 1) a transurethral bulking agent (TBA) or 2) a single-incision sling (SIS). Both interventions are FDA-approved treatment options for urinary incontinence and will be used in line with their approved use. Participants will be randomly assigned to one of the interventions. A total of 358 women will be randomized 1:1 to TBA or SIS. All participants will have data including demographics, medical history, and quality of life assessments as they relate to urinary incontinence collected at baseline. After undergoing treatment (either transurethral bulking agent or single-incision sling), participants will be asked to return to the clinic at 2-4 weeks, 3 months, and 12 months with additional follow-ups at 6 months, 24 months, and 36 months done over the phone. The primary outcome of the BASIS trial is subjective success measured by PGI-I for TBA vs. SIS at 12 months. Secondary outcomes include assessments of 1) retreatment rates within 12 months; 2) validated, objective measures of condition improvement through 36 months; 3) objective success at 3 and 12 months as measured by standardized cough stress test; 4) functional outcomes (activity level, perceived recover, sexual function, etc.); 5) quality of life assessments; 6) operative procedure data and adverse events; 7) pain and functional activity, need for sedation and anesthesia, de novo or worsening symptoms; 8) medical resource use (additional medications, procedures, or therapies); and 9) healthy utility measures.

Conditions

• Stress Urinary Incontinence
• Urinary Incontinence
• Mixed Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Solyx Single-incision Sling	Minimally invasive mesh device placed to treat stress urinary incontinence.
DEVICE	Bulkamid Transurethral Bulking Agent	Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed

Timeline

• Start date: 2024-08-28
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2024-06-28
• Last updated: 2025-12-31

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study