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

Urinary Incontinence Clinical Trial

— SOUNDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186041
• Other study ID #: 1.05.7008
• Status: Completed
• Start date: August 2014
• Est. completion date: March 22, 2021

Study information

• Verified date: July 2021
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: March 22, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Over Active Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Retention

Intervention

Device:
• Sacral Nerve Modulation

Locations

Country	Name	City	State
France	Centre Hospitalier du Pays d'Aix	Aix en Provence
France	CHIC Alencon Mamers	Alencon
France	CHU Angers	Angers
France	Hopital Prive Sevigné	Cesson Sevigné
France	Clinique Chirurgicale du Pre	Le Mans
France	CHRU Lille	Lille
France	Clinique Mutualiste de la porte de l'Orient	Lorient
France	Clinique Mutualiste de la Porte de lOrient	Lorient
France	APHM Hôpital Nord	Marseille
France	APM Hopital de La Conception	Marseille
France	Hopital Robert Schuman	Metz
France	CHU de Nantes - Hôtel Dieu	Nantes
France	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris
France	CHU Bordeaux - Centre Universitaire Pellegrin	Pessac
France	Maison des consultations - Centre Briochin d'Urologie	Plerin
France	Groupe Courlancy	Reims
France	CH Roubaix	Roubaix
France	CHU Rouen - Hopital Charles Nicolle	Rouen
France	Clinique Urologique Nantes Atlantis	Saint Herblain
France	CH Sarreguemines	Sarreguemines
France	Hopital Civil Strasbourg	Strasbourg
France	Polyclinique Ormeau	Tarbes
France	CHU Toulouse - Hopital Rangueil	Toulouse
France	Clinique Ambroise Pare	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
MedtronicNeuro	Medtronic France SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and Performance (5 years) - Objective #2	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.	5 years
Secondary	Concomitant treatment - Objective #3	To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.	Up to 5 years
Secondary	NRS evaluation - Objective#4	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.	Up to 5 years
Secondary	Effect of Therapy in UR patients - Objective #5	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.	Up to 5 years
Secondary	Effect of therapy on OAB patients - Objective#6	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.	Up to 5 years
Secondary	Quality of Life (DITROVIE) - Objective#7	To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.	Up to 5 years
Secondary	Quality of Life (EQ-5D-5L) - Objective#8	To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.	Up to 5 years
Secondary	Urinary symptoms (USP) - Objective#9	To evaluate the change of urinary symptoms of all patients implanted with Interstim® using the Urinary Symptom Profile (USP) questionnaire.	Up to 5 years
Secondary	Goal attainment assessment - Objective#10	To evaluate the long term goal attainment assessed by the GAS.	Up to 5 years
Secondary	Assessment of Fecal Incontinence - Objective#11	To assess the therapy effect on fecal incontinence for subset of patients with double incontinence using the WEXNER fecal incontinence score.	Up to 5 years