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Mesh vs. your own tissue: which sling is safer for stress incontinence?

NCT ID NCT07276295

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study compares two surgical procedures for stress urinary incontinence in women aged 60 and older: a synthetic mesh sling (TVT) and a sling made from the patient's own tissue (autologous fascia). Researchers will track new pelvic pain at 6 months and cure rates at 5 years, along with opioid use and mental health. The goal is to find which approach offers better long-term results with fewer side effects.

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 procedure
What this could lead to
If successful, this could help doctors choose the better surgical option for stress incontinence, reducing long-term pain and improving cure rates.
What could go wrong
This is a mid-stage trial with 232 participants, so results may not apply to all patients. Both procedures carry surgical risks like infection or pain.

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 232 people

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

Started

Jan 2026

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

60 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: * Adult females at birth (female anatomy, any gender) * Greater than or equal to 60 years old * Have stress predominant urinary incontinence (spUI) eligible for both types of surgery (tension-free vaginal tape and autologous fascia sling) * Exhausted conservative management options for UI (Kegel's exercises, physiotherapy, pessary) * Completed childbearing * Able to follow up with clinic visits for up to five years after surgery Exclusion Criteria: * Clinical Frailty Score of 6 or more, as moderate frailty is likely associated with excessive postoperative deterioration * Concurrent pelvic surgery * Neurogenic bladder * Previous UI surgery * Previous pelvic radiation * Previous mesh exposure * Presence of pelvic pain for more than three months in the last five years * Likely unable to follow up * Immunocompromised individuals receiving immunosuppressive medications for at least 3 months * Chronic systemic steroid use for at least 3 months for autoimmune diseases * Unable to stop smoking for at least 3 months prior to surgery and at high risk of restart smoking post-operatively

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence

As listed by the trial registrant

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

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

  • St. Paul's Hospital

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

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