Overview

This trial is active, not recruiting.

Conditions urinary incontinence, over active bladder, urinary retention
Treatment sacral nerve modulation
Sponsor Medtronic International Trading Sarl
Collaborator Medtronic France SAS
Start date August 2014
End date August 2018
Trial size 250 participants
Trial identifier NCT02186041, 1.05.7008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.
sacral nerve modulation Interstim
Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.
sacral nerve modulation Interstim
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
sacral nerve modulation Interstim

Primary Outcomes

Measure
Safety and Performance (2 years) - Objective #1
time frame: 24 months

Secondary Outcomes

Measure
Safety and Performance (5 years) - Objective #2
time frame: 5 years
Concomitant treatment - Objective #3
time frame: Up to 5 years
NRS evaluation - Objective#4
time frame: Up to 5 years
Effect of Therapy in UR patients - Objective #5
time frame: Up to 5 years
Effect of therapy on OAB patients - Objective#6
time frame: Up to 5 years
Quality of Life (DITROVIE) - Objective#7
time frame: Up to 5 years
Quality of Life (EQ-5D-5L) - Objective#8
time frame: Up to 5 years
Urinary symptoms (USP) - Objective#9
time frame: Up to 5 years
Goal attainment assessment - Objective#10
time frame: Up to 5 years
Assessment of Fecal Incontinence - Objective#11
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS):an Observational Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic International Trading Sarl.