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New sling offers hope for women with stress incontinence

NCT ID NCT04115605

Disease control Sponsor: Coloplast A/S 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 followed 598 women who received the Altis Single Incision Sling, a minimally invasive mesh device, to treat stress urinary incontinence. Researchers tracked how well the sling worked and monitored safety over 12 and 36 months after implantation. The goal was to see if the device improves symptoms and has an acceptable safety profile in everyday medical practice.

What this could mean

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

Active substance
Altis Single Incision Sling (a permanently implanted synthetic mesh sling)
What this could lead to
If successful, this could confirm that the Altis sling is a safe and effective long-term option for controlling stress urinary incontinence in women.
What could go wrong
The study was terminated early, so results may be incomplete. As an observational study, it cannot prove cause and effect, and individual results may vary.

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

598 people

The number who actually took part.

Started

May 2015

Finished

Jun 2022

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 implanted with Altis Single Incision Sling System to treat stress urinary incontinence

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: * Implanted with Altis Single Incision Sling System Exclusion Criteria: * Refuses to be included in the survey or that their medical data will be used for research purposes * Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.

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Conditions

The condition(s) this trial relates to.

female stress incontinence Urinary Incontinence, Stress

As listed by the trial registrant

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

Urinary incontinence,stress

Contacts and locations

Locations

  • Armand Brillart Hospital

    Nogent-sur-Marne, 94130, France

  • Azienda USL Valle d'Aosta

    Aosta, 11100, Italy

  • CH Libourne

    Libourne, 33500, France

  • CH Paul Ardier

    Issoire, 63503, France

  • CHI Poissy Saint Germain en Laye

    Poissy, 78303, France

  • CHRU Hotel Dieu

    Angers, 49933, France

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Pellegrin-Urology Departement

    Bordeaux, 33076, France

  • CHU Pellegrin_Gyneacology Departement

    Bordeaux, 33076, France

  • Centre Clinical

    Soyaux, 16800, France

  • Centre Hospitalier Saint Louis

    La Rochelle, 17019, France

  • Clinique Ambroise Paré

    Toulouse, 31082, France

  • Clinique Champeau Mediterranée

    Béziers, 34535, France

  • Clinique Mutualiste de la Porte de l'Orient

    Lorient, 56100, France

  • Clinique Rhône Durance

    Avignon, 84082, France

  • Clinique Saint Jean Languedoc

    Toulouse, 31077, France

  • Clinique Saint-Amé

    Lambres-lez-Douai, 59552, France

  • Clinique Saint-Charles

    La Roche-sur-Yon, 85106, France

  • Clinique St Hilaire

    Rouen, 76044, France

  • Clinique du Mail La Rochelle

    La Rochelle, 17087, France

  • Frauenärzte im Seenland

    Gunzenhausen, 91710, Germany

  • Hosital Clinico de Valladolid

    Valladolid, 47003, Spain

  • Hospital Univeritario Joan XXIII

    Tarragona, 43005, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital la Fé

    Valencia, 46026, Spain

  • Hôpital Victor Jousselin

    Dreux, 28102, France

  • Hôpital du Pays d'Autan

    Castres, 81108, France

  • Hôpital privé Jacques Cartier

    Massy, 91349, France

  • Klinikum Memmingen

    Memmingen, 87700, Germany

  • Klinikum Worms gGmbH

    Worms, 67550, Germany

  • Polyclinique Jean Villars

    Bruges, 33523, France

  • Pôle Santé Léonard de Vinci

    Chambray-lès-Tours, 37170, France

  • UZ Leuven

    Leuven, 3000, Belgium

More trials for these conditions

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