MedDataX Logo

A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence

NCT ID: NCT04115605

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

599 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-27

Study Completion Date

2023-09-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence

NCT02049840

Stress Urinary Incontinence
COMPLETED NA

The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

NCT01272284

Stress Urinary Incontinence
COMPLETED NA

Altis® 522 Trial - Treatment of Female Stress Urinary Incontinence

NCT02348112

Stress Urinary Incontinence
COMPLETED

Mid Term Safety and Efficacy of ALTIS® Single Incision Sling for Female Stress Urinary Incontinence (SUI).

NCT03620604

Urinary Incontinence,Stress
UNKNOWN

Retropubic vs. Single-Incision Mid-Urethral Sling for Stress Urinary Incontinence

NCT03520114

Stress Urinary Incontinence Pelvic Floor Disorders
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Incontinence, Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Altis Single Incision Sling

Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grégoire Capon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Pellegrin, Bordeaux, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Leuven

Leuven, , Belgium

Site Status

CHRU Hotel Dieu

Angers, , France

Site Status

Clinique Rhône Durance

Avignon, , France

Site Status

Clinique Champeau Mediterranée

Béziers, , France

Site Status

CHU Pellegrin-Urology Departement

Bordeaux, , France

Site Status

CHU Pellegrin_Gyneacology Departement

Bordeaux, , France

Site Status

Polyclinique Jean Villars

Bruges, , France

Site Status

Hôpital du Pays d'Autan

Castres, , France

Site Status

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, , France

Site Status

CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Hôpital Victor Jousselin

Dreux, , France

Site Status

CH Paul Ardier

Issoire, , France

Site Status

Clinique Saint-Charles

La Roche-sur-Yon, , France

Site Status

Centre Hospitalier Saint Louis

La Rochelle, , France

Site Status

Clinique du Mail La Rochelle

La Rochelle, , France

Site Status

Clinique Saint-Amé

Lambres-lez-Douai, , France

Site Status

CH Libourne

Libourne, , France

Site Status

Clinique Mutualiste de la Porte de l'Orient

Lorient, , France

Site Status

Hôpital privé Jacques Cartier

Massy, , France

Site Status

Armand Brillart Hospital

Nogent-sur-Marne, , France

Site Status

CHI Poissy Saint Germain en Laye

Poissy, , France

Site Status

Clinique St Hilaire

Rouen, , France

Site Status

Centre Clinical

Soyaux, , France

Site Status

Clinique Saint Jean Languedoc

Toulouse, , France

Site Status

Clinique Ambroise Paré

Toulouse, , France

Site Status

Frauenärzte im Seenland

Gunzenhausen, , Germany

Site Status

Klinikum Memmingen

Memmingen, , Germany

Site Status

Klinikum Worms gGmbH

Worms, , Germany

Site Status

Azienda USL Valle d'Aosta

Aosta, , Italy

Site Status

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Univeritario Joan XXIII

Tarragona, , Spain

Site Status

Hospital la Fé

Valencia, , Spain

Site Status

Hosital Clinico de Valladolid

Valladolid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium France Germany Italy Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SU017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women
NCT03515109 UNKNOWN NA
Solyx Single-Incision SlingDynamic Intraoperative Standing Sling Technique (DISST) as an Office-based Procedure
NCT03842410 ACTIVE_NOT_RECRUITING NA
Biological Sling Allograft (UVT) for the Treatment of Urinary Incontinence in Women Presenting With Synthetic Sling Complications
NCT05207189 COMPLETED PHASE2
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
NCT04098822 RECRUITING
Surgery for Male Stress Urinary Incontinence
NCT05771168 RECRUITING
5-Year Objective and Subjective Results of a Mid-Urethral Sling
NCT01657916 COMPLETED
ARTUS MONO Artificial Urinary Sphincter
NCT03703843 COMPLETED NA
Single-incision Versus Retropubic Mid-Urethral Sling (Solyx) for SUI During Minimally Invasive Sacrocolpopexy
NCT04586166 RECRUITING NA
Virtue® European Study
NCT01608789 COMPLETED NA
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
NCT00998790 COMPLETED NA
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
NCT06968741 RECRUITING NA
Clinical Evaluation of Ajust™ in Stress Urinary Incontinence
NCT01290796 COMPLETED NA
Treatment of Female Stress Urinary Incontinence: Study Comparing Two Suburethral Slings, Retropubic Approach (TVT) and Trans-Obturator (TVT-O) Approach
NCT00135616 UNKNOWN PHASE4
Virtue® Male Incontinence Sling Study
NCT00856778 COMPLETED NA
Desara ® One Single Incision Sling 522 Study
NCT04772131 RECRUITING NA
Surgical Management for Suburethral Slings
NCT02785016 RECRUITING
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.
NCT03916471 UNKNOWN NA
Laparoscopic Burch Colposuspension Versus Midurethral Sling for Treatment of Female Stress Urinary Incontinence a Randomized Controlled Trial
NCT04775186 UNKNOWN NA
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
NCT00113555 COMPLETED NA
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
NCT03195361 COMPLETED NA
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence
NCT05647070 RECRUITING NA
A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence (Urinary Leakage)
NCT00196521 COMPLETED NA
Study of Pant Type Absorbing Urinary Incontinence Products
NCT05031442 COMPLETED NA
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
NCT04827199 NOT_YET_RECRUITING NA
Clinical Investigation to Assess a New Artificial Urinary Sphincter to Treat Urinary Incontinence in Women
NCT05828979 ACTIVE_NOT_RECRUITING NA