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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
NCT06480227 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06480227
The ClinicalTrials.gov registry entry for NCT06480227 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06480227 reports 7 study locations spanning 6 distinct geographic areas — top geographies include California, Illinois, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06480227?
The interventions under investigation include: Solyx Single-incision Sling (DEVICE), Bulkamid Transurethral Bulking Agent (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06480227?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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