Injection vs sling: which works better for leaky bladder?

NCT ID NCT06480227

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two procedures for stress urinary incontinence (leaking urine with cough, sneeze, or exercise) in 358 women. One group gets a bulking agent injection to thicken the urethra lining; the other gets a small mesh sling to support the urethra. The goal is to see which provides more relief at 12 months.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Bulkamid Transurethral Bulking Agent (injection) and Solyx Single-Incision Sling (mesh device)
What this could lead to
If this trial succeeds, it could show which of two minimally invasive procedures works better for stress urinary incontinence, helping women choose the most effective treatment.
What could go wrong
This is a comparative effectiveness trial, not a cure. Both procedures have risks like infection, pain, or failure, and results may not apply to all women.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Pelvic Floor Disorders Urinary Incontinence Urinary Incontinence, Stress

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery

    RECRUITING

    Durham, North Carolina, 27707, United States

  • Kaiser Permanente -- San Diego

    RECRUITING

    San Diego, California, 92110, United States

  • University of California at San Diego

    RECRUITING

    La Jolla, California, 92037-0974, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

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