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

MedtronicNeuro320 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

320

Conditions

Urinary Incontinence Over Active Bladder Urinary Retention

Interventions

Sacral Nerve ModulationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

CHIC Alencon Mamers

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 5 years

Concomitant treatment - Objective #3

To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.

Time frame: Up to 5 years

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.

Time frame: Up to 5 years

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.

Time frame: Up to 5 years

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.

Time frame: Up to 5 years

Data from ClinicalTrials.gov

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