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NCT06480227 · ClinicalTrials.gov registry record · NA
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
A NA study of Urinary Incontinence and Stress Urinary Incontinence, sponsored by NICHD Pelvic Floor Disorders Network.
- Recruiting
- Registry status
- NA
- Development phase
- 358
- Enrollment target
- 7
- Study locations
NCT06480227: Recruiting NA study of Urinary Incontinence and Stress Urinary Incontinence, sponsored by NICHD Pelvic Floor Disorders Network.
NCT06480227 is a NA study of Urinary Incontinence and Stress Urinary Incontinence that is actively recruiting participants, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 358 participants, above the 255-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (40% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06480227, a NA study of Urinary Incontinence and Stress Urinary Incontinence, is actively recruiting participants, sponsored by NICHD Pelvic Floor Disorders Network.
- RECRUITING
- Registry status
- NA
- Development phase
- 358 participants
- Enrollment target
- 7
- Study locations
Study 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).
Primary Outcome
The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence.
Conditions Studied
Interventions
- DEVICE Solyx Single-incision Sling
- DEVICE Bulkamid Transurethral Bulking Agent
Study Locations (7)
California
- University of California at San Diego - La Jolla
- Kaiser Permanente -- San Diego - San Diego
Illinois
- University of Chicago - Chicago
North Carolina
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery - Durham
Pennsylvania
- University of Pennsylvania - Philadelphia
Rhode Island
- Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery - Providence
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2030-01-01 |
| Phase | NA |
What NCT06480227 shows while recruiting
NCT06480227 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, above the 255-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (40% higher).
The record links to 3 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Solyx Single-incision Sling is the first listed.
NCT06480227 lists 7 locations in 6 states (California, Illinois, North Carolina).
Frequently Asked Questions
What is clinical trial NCT06480227 about?
NCT06480227 is a clinical study titled "Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence". 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...
What is the current status of trial NCT06480227?
This trial is currently recruiting. It is a NA study. The enrollment target is 358 participants. The study started on 2024-08-28. Estimated completion is 2030-01-01.
What conditions does trial NCT06480227 study?
This clinical trial studies the following conditions: Urinary Incontinence, Stress Urinary Incontinence, Mixed Urinary Incontinence.
What interventions are being tested in trial NCT06480227?
The interventions under investigation include: Solyx Single-incision Sling (DEVICE), Bulkamid Transurethral Bulking Agent (DEVICE).
Who is sponsoring clinical trial NCT06480227?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06480227 being conducted?
This trial has 7 study locations across California, Illinois, North Carolina, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06480227's enrollment target sits among peer trials
358 11th of 48 higher than 38 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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