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

Which sling is best for leakage? new trial compares One-Cut vs. Two-Cut methods

NCT ID NCT04586166

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of sling surgery for stress urinary incontinence (leaking urine with cough or sneeze) in women who are also having surgery for pelvic organ prolapse. One sling uses a single incision, the other uses two incisions. The trial will enroll 180 women and measure how bothersome their incontinence is after surgery.

What this could mean

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

Active substance
Surgical sling (device)
What this could lead to
If one sling type works better, it could improve surgical choices for women needing both prolapse and incontinence repair.
What could go wrong
This is a non-inferiority trial, so it may only show that the newer sling is not worse, not better. 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 180 people

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

Started

Dec 2020

Expected to finish

Dec 2032

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

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: * At least 21 years of age * Vaginal bulge symptoms as indicated by an affirmative response of \>1 to question 3 of the PFDI-SF20 * POP ≥ stage II according to the pelvic organ prolapse quantification (POP-Q) system45, with evidence of apical descent * Women being considered for minimally invasive sacrocolpopexy (with or without concomitant hysterectomy) * Objective SUI: positive standardized cough stress test on clinical examination or on urodynamic study with reduced prolapse * Understanding and acceptance of the need to return for all scheduled follow-up visits and willing to complete study questionnaires * Able to give informed consent Exclusion Criteria: * Prior surgery for stress urinary incontinence including mid-urethral sling; Burch/MMK; fascial pubovaginal sling (autologous, xenograft or allograft); and urethral bulking injection * Any serious disease, or chronic condition, that could interfere with the study compliance * Unwilling to have a synthetic sling * Untreated and unresolved urinary tract infection * Poorly-controlled diabetes mellitus (HgbA1c \> 9 within 3 months of surgery date) * Neurogenic bladder/ pre-operative self-catheterization * Elevated post-void residual/PVR (\>150 ml) that does not resolve with prolapse reduction testing (pessary, prolapse reduced uroflow or micturition study) * Prior pelvic radiation * Inflammatory bowel disease * Current genitourinary fistula or urethral diverticulum * Planned concomitant bowel related surgery including sphincteroplasty and perineal rectal prolapse surgery, rectovaginal fistula repair, hemorrhoidectomy * Pregnant or Planning to Conceive * Incarcerated

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

female stress incontinence Pelvic Floor Disorders pelvic organ prolapse Urinary Incontinence, Stress

As listed by the trial registrant

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

Pelvic floor disorders Stress urinary incontinence

Contacts and locations

Locations

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Florida Robotic and Minimally Invasive Urogynecology

    Coconut Creek, Florida, 33073, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27101, United States

More trials for these conditions

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