Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
SOUNDS
1 other identifier
observational
320
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2021
CompletedJuly 16, 2021
July 1, 2021
6.6 years
July 4, 2014
July 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Performance (2 years) - Objective #1
To evaluate the safety of Interstim® therapy and the performance of the Interstim® system in the 2 years following the enrollment. The rate of surgical revisions/explantations of the Interstim® system or any of its parts will be measured.
24 months
Secondary Outcomes (10)
Safety and Performance (5 years) - Objective #2
5 years
Concomitant treatment - Objective #3
Up to 5 years
NRS evaluation - Objective#4
Up to 5 years
Effect of Therapy in UR patients - Objective #5
Up to 5 years
Effect of therapy on OAB patients - Objective#6
Up to 5 years
- +5 more secondary outcomes
Study Arms (3)
De-Novo patients
Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.
Device replacement
Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.
Not-implanted patients
Patients who are tested and are not implanted with the Interstim® system. The data of the follow up of the test will be captured up to one year after the end-test visit
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Difficulty of collecting follow up patient data;
- Patient not affiliated to social security.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
- Medtronic France SAScollaborator
Study Sites (24)
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, 13616, France
CHIC Alencon Mamers
Alençon, 61000, France
CHU Angers
Angers, 49933, France
Hopital Prive Sevigné
Cesson Sevigné, 35576, France
Clinique Chirurgicale du Pre
Le Mans, 72018, France
CHRU Lille
Lille, 59037, France
Clinique Mutualiste de la porte de l'Orient
Lorient, 56324, France
Clinique Mutualiste de la Porte de lOrient
Lorient, 56324, France
APM Hopital de La Conception
Marseille, 13005, France
APHM Hôpital Nord
Marseille, 13385, France
Hopital Robert Schuman
Metz, 57070, France
CHU de Nantes - Hôtel Dieu
Nantes, 44093, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75020, France
CHU Bordeaux - Centre Universitaire Pellegrin
Pessac, 33076, France
Maison des consultations - Centre Briochin d'Urologie
Plérin, 22190, France
Groupe Courlancy
Reims, 51100, France
CH Roubaix
Roubaix, 59056, France
CHU Rouen - Hopital Charles Nicolle
Rouen, 76031, France
Clinique Urologique Nantes Atlantis
Saint-Herblain, 44800, France
CH Sarreguemines
Sarreguemines, 57211, France
Hopital Civil Strasbourg
Strasbourg, 67091, France
Polyclinique Ormeau
Tarbes, 65000, France
CHU Toulouse - Hopital Rangueil
Toulouse, 31059, France
Clinique Ambroise Pare
Toulouse, 31082, France
Related Publications (2)
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.
PMID: 34334342DERIVEDChartier-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.
PMID: 32907782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 10, 2014
Study Start
August 1, 2014
Primary Completion
March 22, 2021
Study Completion
March 22, 2021
Last Updated
July 16, 2021
Record last verified: 2021-07