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A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
Sponsor: Coloplast A/S
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.
Official title: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
598
Start Date
2015-05-23
Completion Date
2022-06-24
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Altis Single Incision Sling
Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence
Locations (33)
UZ Leuven
Leuven, Belgium
CHRU Hotel Dieu
Angers, France
Clinique Rhône Durance
Avignon, France
Clinique Champeau Mediterranée
Béziers, France
CHU Pellegrin-Urology Departement
Bordeaux, France
CHU Pellegrin_Gyneacology Departement
Bordeaux, France
Polyclinique Jean Villars
Bruges, France
Hôpital du Pays d'Autan
Castres, France
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Hôpital Victor Jousselin
Dreux, France
CH Paul Ardier
Issoire, France
Clinique Saint-Charles
La Roche-sur-Yon, France
Centre Hospitalier Saint Louis
La Rochelle, France
Clinique du Mail La Rochelle
La Rochelle, France
Clinique Saint-Amé
Lambres-lez-Douai, France
CH Libourne
Libourne, France
Clinique Mutualiste de la Porte de l'Orient
Lorient, France
Hôpital privé Jacques Cartier
Massy, France
Armand Brillart Hospital
Nogent-sur-Marne, France
CHI Poissy Saint Germain en Laye
Poissy, France
Clinique St Hilaire
Rouen, France
Centre Clinical
Soyaux, France
Clinique Saint Jean Languedoc
Toulouse, France
Clinique Ambroise Paré
Toulouse, France
Frauenärzte im Seenland
Gunzenhausen, Germany
Klinikum Memmingen
Memmingen, Germany
Klinikum Worms gGmbH
Worms, Germany
Azienda USL Valle d'Aosta
Aosta, Italy
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Univeritario Joan XXIII
Tarragona, Spain
Hospital la Fé
Valencia, Spain
Hosital Clinico de Valladolid
Valladolid, Spain