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

Medtronic

Status: Completed

Conditions: Urinary Retention; Over Active Bladder; Urinary Incontinence

Treatments: Device: Sacral Nerve Modulation

Study type: Observational

Funder types: Industry

Identifiers

NCT02186041

1.05.7008

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

320 participants in 3 patient groups

De-Novo patients

Description:

Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.

Treatment:

Device: Sacral Nerve Modulation

Device replacement

Description:

Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.

Treatment:

Device: Sacral Nerve Modulation

Not-implanted patients

Description:

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

Treatment:

Device: Sacral Nerve Modulation