Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study

Completed

• Conditions: Urinary Retention; Over Active Bladder; Urinary Incontinence
• Interventions: Device: Sacral Nerve Modulation

• Registration Number: NCT02186041
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-10
• Study Start: 2014-08
• Primary Completion: 2021-03-22
• Study Completion: 2021-03-22
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device replacement	Sacral Nerve Modulation	Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.
De-Novo patients	Sacral Nerve Modulation	Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.
Not-implanted patients	Sacral Nerve Modulation	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

Primary Outcome Measures

Name	Time	Method
Safety and Performance (2 years) - Objective #1	24 months	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.

Secondary Outcome Measures

Name	Time	Method
Urinary symptoms (USP) - Objective#9	Up to 5 years	To evaluate the change of urinary symptoms of all patients implanted with Interstim® using the Urinary Symptom Profile (USP) questionnaire.
Goal attainment assessment - Objective#10	Up to 5 years	To evaluate the long term goal attainment assessed by the GAS.
Safety and Performance (5 years) - Objective #2	5 years	To evaluate the safety of Interstim® therapy and the performance of the Interstim® system in the 5 years following the enrollment.; The rate of adverse device events and device deficiencies will be measured.
Quality of Life (DITROVIE) - Objective#7	Up to 5 years	To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.
Concomitant treatment - Objective #3	Up to 5 years	To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.
Effect of therapy on OAB patients - Objective#6	Up to 5 years	To assess the effect of Interstim® therapy on the subset of patients with Over Active Bladder (OAB wet and OAB dry) symptom as measured by the number of voids and leaks per day.
NRS evaluation - Objective#4	Up to 5 years	To evaluate the effect of InterStim® therapy on the perceived bother resulting from conditions as measured on Numeric Rating Scale (NRS) up to 5 years follow up.
Quality of Life (EQ-5D-5L) - Objective#8	Up to 5 years	To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.
Effect of Therapy in UR patients - Objective #5	Up to 5 years	To assess the effect of Interstim® therapy on the subset of patients with urinary retention as measured by the number of self-catheterizations per day.
Assessment of Fecal Incontinence - Objective#11	Up to 5 years	To assess the therapy effect on fecal incontinence for subset of patients with double incontinence using the WEXNER fecal incontinence score.

Trial Locations

Locations (24)

CHIC Alencon Mamers; 🇫🇷 Alencon, France

CHRU Lille; 🇫🇷 Lille, France

Clinique Mutualiste de la porte de l'Orient; 🇫🇷 Lorient, France

APHM Hôpital Nord; 🇫🇷 Marseille, France

Centre Hospitalier du Pays d'Aix; 🇫🇷 Aix en Provence, France

Hopital Civil Strasbourg; 🇫🇷 Strasbourg, France

Hopital Robert Schuman; 🇫🇷 Metz, France

Maison des consultations - Centre Briochin d'Urologie; 🇫🇷 Plerin, France

Polyclinique Ormeau; 🇫🇷 Tarbes, France

Clinique Ambroise Pare; 🇫🇷 Toulouse, France

CH Roubaix; 🇫🇷 Roubaix, France

CHU Toulouse - Hopital Rangueil; 🇫🇷 Toulouse, France

Hopital Prive Sevigné; 🇫🇷 Cesson Sevigné, France

CHU Angers; 🇫🇷 Angers, France

Clinique Chirurgicale du Pre; 🇫🇷 Le Mans, France

Clinique Mutualiste de la Porte de lOrient; 🇫🇷 Lorient, France

APM Hopital de La Conception; 🇫🇷 Marseille, France

Groupe Hospitalier Diaconesses Croix Saint-Simon; 🇫🇷 Paris, France

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

CHU Bordeaux - Centre Universitaire Pellegrin; 🇫🇷 Pessac, France

Clinique Urologique Nantes Atlantis; 🇫🇷 Saint Herblain, France

CH Sarreguemines; 🇫🇷 Sarreguemines, France

CHU Rouen - Hopital Charles Nicolle; 🇫🇷 Rouen, France

Groupe Courlancy; 🇫🇷 Reims, France