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Pelvic mesh registry aims to track outcomes over a decade

NCT ID NCT04829175

Knowledge-focused Sponsor: Ethicon, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study is a long-term registry that will follow 1,000 women who receive pelvic mesh products for stress urinary incontinence or pelvic organ prolapse. Researchers will track how well the mesh works and any complications over 5 to 10 years. The goal is to gather real-world data on safety and effectiveness.

What this could mean

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

What this could lead to
If successful, this registry could provide reliable long-term safety and effectiveness data for pelvic mesh products, helping doctors and patients make informed decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may take years and could show complications or limited benefit.

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.

Participants

About 1,000 people

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

Started

Apr 2022

Expected to finish

Mar 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Female patients ≥ 21 years of age with: * A diagnosis of SUI, resulting from urethral hypermobility and/or intrinsic sphincter deficiency AND/OR * A diagnosis of vaginal vault or uterine prolapses where surgical treatment (sacrocolposuspension or sacrocolpopexy, laparotomic or laparoscopic approach including robotic assisted) is warranted AND * Are scheduled to have surgical treatment using an Ethicon Gynecare Pelvic Mesh Product

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: Patients who satisfy all of the following criteria will be considered eligible for enrollment in this registry: SUI 1. Stress urinary incontinence symptoms 2. Urodynamic stress incontinence confirmed with urodynamic testing 3. Female patient ≥ 21 years of age 4. Desired surgical correction of SUI using synthetic pubo-urethral vaginal sling 5. Planned surgery for primary SUI 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent POP 1\. Uterine or vaginal vault prolapse symptoms 2. Urodynamic testing (optional) 3. Female patient ≥ 21 years of age 4. Desired surgical correction of POP using synthetic mesh 5. Planned surgery for uterine or vaginal vault prolapse with or without concomitant SUI surgery 6. Patient able and willing to participate in follow-up 7. Patient or authorized representative has signed the approved Informed consent Exclusion Criteria Patients meeting any of the following criteria will be considered not eligible for enrollment in this registry: 1. Physical or psychological condition which would impair registry participation or are unwilling or unable to participate in all required registry visits and are unable to complete the questionnaires 2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of registry products 3. History of previous synthetic, biologic or fascial sub-urethral sling (SUI) or pelvic mesh (POP) 4. Pregnancy or plans for future pregnancy 5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice 6. Current genitourinary fistula or urethral diverticulum 7. Reversible cause of incontinence (i.e. drug effect) for SUI only 8. Severe vaginal atrophy 9. History of pelvic irradiation therapy 10. Contraindication to surgery

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Conditions

The condition(s) this trial relates to.

female stress incontinence pelvic organ prolapse Urinary Incontinence, Stress

As listed by the trial registrant

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

Pelvic organ prolapse Stress 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

    9 sites in 6 countries. 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

  • Bio-Medical University Rome

    RECRUITING

    Rome, Italy

  • Duke University

    RECRUITING

    Durham, North Carolina, 27707, United States

  • Herlev Hospital

    NOT_YET_RECRUITING

    Hillerød, Denmark

  • Hopital Jeanne de Flandres

    NOT_YET_RECRUITING

    Lille, France

  • Karolinska Institute

    RECRUITING

    Stockholm, Sweden

  • Krankenhaus der barmherzigen Schwestern

    RECRUITING

    Linz, Austria

  • UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Universitatsklinikum Tubingen

    ACTIVE_NOT_RECRUITING

    Tübingen, Germany

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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