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Injection vs sling: which works better for leaky bladder?

NCT ID NCT06480227

Disease control Sponsor: NICHD Pelvic Floor Disorders Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 358 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women ≥ 21 years * For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required. * A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months. * Normal PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon * Available for up to 3 years. * Agrees to randomization. Exclusion Criteria: * Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) * Urge-predominant mixed UI despite stable therapy * Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment. * Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months. * Malignancy or history of radiation of the pelvis * Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year * Incomplete emptying (PVR \> 150mL) * Prior anti-incontinence procedure * Neurogenic bladder * Unwilling to continue current UUI treatment until completion of primary outcome at 12 months * Prior adverse reaction to synthetic mesh or urethral bulking material * Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) * Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.

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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.

Mixed urinary incontinence Stress urinary incontinence Urinary incontinence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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