Clinical trial NCT02186041: Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
Official title: Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS):an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Over Active Bladder
Urinary Retention
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
Collaborators: name: Medtronic France SAS
First posted: 2014-07-10
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are eligible for Interstim® therapy for the treatment of intractable urinary voiding dysfunctions will be proposed to participate to the registry in a representative selection of French centers.

Brief summary: The purpose of this study is to document the safety, the effectiveness, the continued performance at mid and long term, the morbidity and the percent of surgical revisions of the Interstim® therapy for up to 5 years in a representative sample of French centers under real-life conditions of use.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years old;
* Patient signed the Patient Data Release Form;
* Patient suffering from retention or Over Active Bladder;
* Patient is eligible for Interstim® system therapy.

Exclusion Criteria:

* Difficulty of collecting follow up patient data;
* Patient not affiliated to social security.

Primary outcomes:
measure: Safety and Performance (2 years) - Objective #1
timeFrame: 24 months
Secondary outcomes:
measure: Safety and Performance (5 years) - Objective #2
timeFrame: 5 years
measure: Concomitant treatment - Objective #3
timeFrame: Up to 5 years
measure: NRS evaluation - Objective#4
timeFrame: Up to 5 years
measure: Effect of Therapy in UR patients - Objective #5
timeFrame: Up to 5 years
measure: Effect of therapy on OAB patients - Objective#6
timeFrame: Up to 5 years
measure: Quality of Life (DITROVIE) - Objective#7
timeFrame: Up to 5 years
measure: Quality of Life (EQ-5D-5L) - Objective#8
timeFrame: Up to 5 years
measure: Urinary symptoms (USP) - Objective#9
timeFrame: Up to 5 years
measure: Goal attainment assessment - Objective#10
timeFrame: Up to 5 years
measure: Assessment of Fecal Incontinence - Objective#11
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Alencon
country: France
facility: CHIC Alencon Mamers
city: Angers
country: France
facility: CHU Angers
city: Cesson Sevigné
country: France
facility: Hopital Prive Sevigné
city: Le Mans
country: France
facility: Clinique Chirurgicale du Pre
city: Lille
country: France
facility: CHRU Lille
city: Lorient
country: France
facility: Clinique Mutualiste de la porte de l'Orient
city: Lorient
country: France
facility: Clinique Mutualiste de la Porte de lOrient
city: Marseille
country: France
facility: APM Hopital de La Conception
city: Marseille
country: France
facility: APHM Hôpital Nord
city: Metz
country: France
facility: Hopital Robert Schuman
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Pessac
country: France
facility: CHU Bordeaux - Centre Universitaire Pellegrin
city: Plerin
country: France
facility: Maison des consultations - Centre Briochin d'Urologie
city: Reims
country: France
facility: Groupe Courlancy
city: Roubaix
country: France
facility: CH Roubaix
city: Rouen
country: France
facility: CHU Rouen - Hopital Charles Nicolle
city: Saint Herblain
country: France
facility: Clinique Urologique Nantes Atlantis
city: Sarreguemines
country: France
facility: CH Sarreguemines
city: Strasbourg
country: France
facility: Hopital Civil Strasbourg
city: Tarbes
country: France
facility: Polyclinique Ormeau
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Rangueil
city: Toulouse
country: France
facility: Clinique Ambroise Pare
Study officials:
References:
citation: Chartier-Kastler E, Normand LL, Ruffion A, Saussine C, Braguet R, Rabut B, Ragni E, Perrouin-Verbe MA, Pierrevelcin J, Rousseau T, Game X, Tanneau Y, Dargent F, Biardeau X, Graziana JP, Stoica G, Brassart E, Fourmarier M, Yaghi N, Capon G, Ferchaud J, Berrogain N, Peyrat L, Pecoux F, Bryckaert PE, Melotti A, Abouihia A, Keller DUJ, Cornu JN. Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study. Eur Urol Focus. 2022 Sep;8(5):1399-1407. doi: 10.1016/j.euf.2021.06.013. Epub 2021 Jul 30.
citation: Chartier-Kastler E, Le Normand L, Ruffion A, Dargent F, Braguet R, Saussine C, Tanneau Y, Graziana JP, Ragni E, Rabut B, Rousseau T, Biardeau X, Game X, Pierrevelcin J, Brassart E, Fourmarier M, Stoica G, Berrogain N, Yaghi N, Pecoux F, Capon G, Ferchaud J, Peyrat L, Bryckaert PE, Karsenty G, Melotti A, Abouihia A, Keller DUJ, Cornu JN. Sacral Neuromodulation with the InterStim System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study. Eur Urol Focus. 2021 Nov;7(6):1430-1437. doi: 10.1016/j.euf.2020.06.026. Epub 2020 Sep 7.