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

MedtronicNeuro24 sites in 1 country320 target enrollmentAugust 2014

ConditionsUrinary Incontinence Over Active Bladder Urinary Retention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: MedtronicNeuro
Enrollment: 320
Locations: 24
Primary Endpoint: Safety and Performance (2 years) - Objective #1
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

March 22, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Safety and Performance (2 years) - Objective #1

Time Frame: 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.