Clinical trial NCT04115605: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence, Stress
Keywords: Single Incision Sling
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2019-10-04
Enrollment: 599
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female implanted with Altis Single Incision Sling System to treat stress urinary incontinence

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Cough stress test (CST)
timeFrame: Baseline, 8 weeks and 12 months
measure: Post-void residual (PVR) volume
timeFrame: Baseline, 8 weeks and 12 months
measure: Pad Use
timeFrame: Baseline, 8 weeks, 12, 24 and 36 months
measure: International Consultation on Incontinence Questionnaire (ICIQ-UI)
timeFrame: Baseline, 8 weeks, 12, 24 and 36 months
measure: Subject global satisfaction questionnaire
timeFrame: 8 weeks, 12, 24, 36 months
measure: Incontinence quality of life questionnaire (I-QoL)
timeFrame: Baseline, 8 weeks, 12, 24, 36 months
measure: Impact on sexual function assessed by the Pelvic organ/urinary incontinence sexual questionnaire (PISQ 12)
timeFrame: Baseline, 8 weeks, 12, 24, 36 months
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 8 weeks, 24, 36 months
measure: Adverse events
timeFrame: 8 weeks, 24, 36 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Angers
country: France
facility: CHRU Hotel Dieu
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Bordeaux
country: France
facility: CHU Pellegrin-Urology Departement
city: Bordeaux
country: France
facility: CHU Pellegrin_Gyneacology Departement
city: Bruges
country: France
facility: Polyclinique Jean Villars
city: Béziers
country: France
facility: Clinique Champeau Mediterranée
city: Castres
country: France
facility: Hôpital du Pays d'Autan
city: Chambray-lès-Tours
country: France
facility: Pôle Santé Léonard de Vinci
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dreux
country: France
facility: Hôpital Victor Jousselin
city: Issoire
country: France
facility: CH Paul Ardier
city: La Roche sur Yon
country: France
facility: Clinique Saint-Charles
city: La Rochelle
country: France
facility: Centre Hospitalier Saint Louis
city: La Rochelle
country: France
facility: Clinique du Mail La Rochelle
city: Lambres lez douai
country: France
facility: Clinique Saint-Amé
city: Libourne
country: France
facility: CH Libourne
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de l'Orient
city: Massy
country: France
facility: Hôpital privé Jacques Cartier
city: Nogent-sur-Marne
country: France
facility: Armand Brillart Hospital
city: Poissy
country: France
facility: CHI Poissy Saint Germain en Laye
city: Rouen
country: France
facility: Clinique St Hilaire
city: Soyaux
country: France
facility: Centre Clinical
city: Toulouse
country: France
facility: Clinique Saint Jean Languedoc
city: Toulouse
country: France
facility: Clinique Ambroise Paré
city: Gunzenhausen
country: Germany
facility: Frauenärzte im Seenland
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: Worms
country: Germany
facility: Klinikum Worms gGmbH
city: Aosta
country: Italy
facility: Azienda USL Valle d'Aosta
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Tarragona
country: Spain
facility: Hospital Univeritario Joan XXIII
city: Valencia
country: Spain
facility: Hospital la Fé
city: Valladolid
country: Spain
facility: Hosital Clinico de Valladolid
Study officials:
affiliation: CHU Pellegrin, Bordeaux, France
name: Grégoire Capon, MD
role: PRINCIPAL_INVESTIGATOR
References: