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

Study 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.

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

Conditions
-----------------
Urinary Incontinence, Over Active Bladder, Urinary Retention

Intervention / Treatment
-----------------
* Device: Sacral Nerve Modulation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| De-Novo patients<br>Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit. | Device: Sacral Nerve Modulation<br> <br> * Other names: Interstim;|
| Device replacement<br>Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit. | Device: Sacral Nerve Modulation<br> <br> * Other names: Interstim;|
| Not-implanted patients<br>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 | Device: Sacral Nerve Modulation<br> <br> * Other names: Interstim;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Concomitant treatment - Objective #3 | To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions. | 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. | 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. | 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. | Up to 5 years | 
| Quality of Life (DITROVIE) - Objective#7 | To assess the therapy effect on Quality of Life using the DITROVIE questionnaire. | Up to 5 years | 
| 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 | 
| 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 | 
| Goal attainment assessment - Objective#10 | To evaluate the long term goal attainment assessed by the GAS. | Up to 5 years | 
| 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 |