Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Sling vs injection: which works best for leakage after prolapse surgery?

NCT ID NCT06754046

Symptom relief Sponsor: University Hospitals Cleveland Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two procedures—a sling or a bulkamide injection—to treat stress urinary incontinence in women who are also having vaginal prolapse repair. About 476 participants will be randomly assigned to one of the two treatments and followed for 24 months. The goal is to see which approach better reduces bothersome incontinence symptoms and has fewer complications.

What this could mean

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

Active substance
bulkamide injection (PAHG) and retropubic midurethral sling (RP-MUS)
What this could lead to
If successful, this could show which procedure better reduces bothersome incontinence symptoms and has fewer complications, helping guide treatment choices for women undergoing prolapse repair.
What could go wrong
This is a mid-sized trial comparing two established procedures, so no breakthrough is expected. Results may not apply to all patients, and both procedures carry risks like infection or incomplete symptom relief.

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 476 people

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

Started

May 2025

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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 ≥ 18 years of age. * Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR). * Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing, * Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG) Exclusion Criteria: * Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue * Patient anticipating difficulty with completing 24-month follow-up * Anticipation of pregnancy within subsequent 24-months or \<18 months post-partum * Hemoglobin A1c \>10.0% within the past 3-months * Current smoker \> 1 pack per week * History of neurogenic bladder * Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter * Post-void residual \>150 mL felt to not be due to obstruction for prolapse * Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking * Previous history of any pelvic radiation * Patient receiving a planned concurrent procedure at the time of prolapse repair.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Pelvic organ prolapse are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

female stress incontinence pelvic organ prolapse pelvic organ prolapse, susceptibility to Urinary Incontinence, Stress Uterine Prolapse

As listed by the trial registrant

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

Stress urinary incontinence Vaginal prolapse

How to take part

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

  1. The places running it

    1 site. 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

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.