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

NCT04115605 | Terminated Results

• 1 other identifier: SU017
• Study Type: observational
• Target: 598
• Locations: 5 countries
• Sites: 33

Brief Summary

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.

Conditions

Urinary Incontinence, Stress

Keywords

Single Incision Sling

Outcome Measures

Primary Outcomes (3)

• Treatment Success

  Treatment success is a composite criterion defined in the protocol as condition improvement by Patient Global Impression of Improvement (PGI-I) reported as "a little better", "much better" or "very much better" and absence of serious or severe related Adverse Events (AEs) one year after implantation. As this definition of success was not restrictive enough, the Scientific Committee proposed a new definition for the treatment success for the statistical analysis, which was defined by PGI-I reported as "very much better" or "much better" and absence of any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs one year after implantation.

  12 months

• Patient Global Impression of Improvement (PGI-I)

  PGI-I is one of the two outcome measures of the composite primary endpoint. It is a validated question that collects the patients' impression of improvement after the surgery. Among this 7 point-scale ("very much better", "much better", "a little better", "no change", "a little worse", "much worse" and "very much worse"), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describes "very much better" or "much better" or "little better" and the percentage of patients who describes "very much better" or "much better" were measured.

  12 months

• Related Adverse Events

  Related Adverse Events (AEs) are one of the two outcome measures of the composite primary endpoint. All AEs related or judged related to the procedure or the device were reported. The percentage of patients without any severe or serious related AEs and the percentage of patients without any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs were measured.

  12 months

Secondary Outcomes (9)

• Treatment Success

  8 weeks, 24, 36 months

• Cough Stress Test (CST)

  Baseline, 8 weeks and 12 months

• Post-void Residual (PVR) Volume

  Baseline, 8 weeks and 12 months

• Pad Use

  Baseline, 8 weeks, 12, 24 and 36 months

• International Consultation on Incontinence Questionnaire (ICIQ-UI)

  Baseline, 8 weeks, 12, 24 and 36 months

Interventions

Altis Single Incision Sling DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Implanted with Altis Single Incision Sling System

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (33)

UZ Leuven

Leuven, 3000, Belgium

Location

CHRU Hotel Dieu

Angers, 49933, France

Location

Clinique Rhône Durance

Avignon, 84082, France

Location

Clinique Champeau Mediterranée

Béziers, 34535, France

Location

CHU Pellegrin-Urology Departement

Bordeaux, 33076, France

Location

CHU Pellegrin_Gyneacology Departement

Bordeaux, 33076, France

Location

Polyclinique Jean Villars

Bruges, 33523, France

Location

Hôpital du Pays d'Autan

Castres, 81108, France

Location

Pôle Santé Léonard de Vinci

Chambray-lès-Tours, 37170, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Victor Jousselin

Dreux, 28102, France

Location

CH Paul Ardier

Issoire, 63503, France

Location

Clinique Saint-Charles

La Roche-sur-Yon, 85106, France

Location

Centre Hospitalier Saint Louis

La Rochelle, 17019, France

Location

Clinique du Mail La Rochelle

La Rochelle, 17087, France

Location

Clinique Saint-Amé

Lambres-lez-Douai, 59552, France

Location

CH Libourne

Libourne, 33500, France

Location

Clinique Mutualiste de la Porte de l'Orient

Lorient, 56100, France

Location

Hôpital privé Jacques Cartier

Massy, 91349, France

Location

Armand Brillart Hospital

Nogent-sur-Marne, 94130, France

Location

CHI Poissy Saint Germain en Laye

Poissy, 78303, France

Location

Clinique St Hilaire

Rouen, 76044, France

Location

Centre Clinical

Soyaux, 16800, France

Location

Clinique Saint Jean Languedoc

Toulouse, 31077, France

Location

Clinique Ambroise Paré

Toulouse, 31082, France

Location

Frauenärzte im Seenland

Gunzenhausen, 91710, Germany

Location

Klinikum Memmingen

Memmingen, 87700, Germany

Location

Klinikum Worms gGmbH

Worms, 67550, Germany

Location

Azienda USL Valle d'Aosta

Aosta, 11100, Italy

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Univeritario Joan XXIII

Tarragona, 43005, Spain

Location

Hospital la Fé

Valencia, 46026, Spain

Location

Hosital Clinico de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The major concern of this study is the number of patients which decreased over time: over the 564 patients in the ITT population, 545 completed a 2-month assessment, 427 completed a 1-year assessment, 362 completed a 2-year assessment and 307 completed a 3-year assessment.

Results Point of Contact

• Title: Mrs Martine Dehez, Manager, Clinical Quality & EU Clinical Research
• Organization: Coloplast Manufacturing France

frmdeh@coloplast.com

+33634408340

Study Officials

• Grégoire Capon, MD

  CHU Pellegrin, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: October 4, 2019
• Study Start: May 23, 2015
• Primary Completion: September 22, 2021
• Study Completion: June 24, 2022
• Last Updated: May 26, 2026
• Results First Posted: May 26, 2026

Record last verified: 2026-05

Locations

IT (1); DE (3); FR (24); ES (4); BE (1)