Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| De-Novo patients 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
Other Names:
|
| Device replacement 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
Other Names:
|
| Not-implanted patients 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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety and Performance (2 years) - Objective #1 [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.
Secondary Outcome Measures
- Safety and Performance (5 years) - Objective #2 [5 years]
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.
- Concomitant treatment - Objective #3 [Up to 5 years]
To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.
- NRS evaluation - Objective#4 [Up to 5 years]
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.
- Effect of Therapy in UR patients - Objective #5 [Up to 5 years]
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.
- Effect of therapy on OAB patients - Objective#6 [Up to 5 years]
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.
- Quality of Life (DITROVIE) - Objective#7 [Up to 5 years]
To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.
- Quality of Life (EQ-5D-5L) - Objective#8 [Up to 5 years]
To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.
- Urinary symptoms (USP) - Objective#9 [Up to 5 years]
To evaluate the change of urinary symptoms of all patients implanted with Interstim® using the Urinary Symptom Profile (USP) questionnaire.
- Goal attainment assessment - Objective#10 [Up to 5 years]
To evaluate the long term goal attainment assessed by the GAS.
- Assessment of Fecal Incontinence - Objective#11 [Up to 5 years]
To assess the therapy effect on fecal incontinence for subset of patients with double incontinence using the WEXNER fecal incontinence score.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is at least 18 years old;
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Patient signed the Patient Data Release Form;
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Patient suffering from retention or Over Active Bladder;
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Patient is eligible for Interstim® system therapy.
Exclusion Criteria:
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Difficulty of collecting follow up patient data;
-
Patient not affiliated to social security.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier du Pays d'Aix | Aix en Provence | France | 13616 | |
| 2 | CHIC Alencon Mamers | Alencon | France | 61000 | |
| 3 | CHU Angers | Angers | France | 49933 | |
| 4 | Hopital Prive Sevigné | Cesson Sevigné | France | 35576 | |
| 5 | Clinique Chirurgicale du Pre | Le Mans | France | 72018 | |
| 6 | CHRU Lille | Lille | France | 59037 | |
| 7 | Clinique Mutualiste de la porte de l'Orient | Lorient | France | 56324 | |
| 8 | Clinique Mutualiste de la Porte de lOrient | Lorient | France | 56324 | |
| 9 | APM Hopital de La Conception | Marseille | France | 13005 | |
| 10 | APHM Hôpital Nord | Marseille | France | 13385 | |
| 11 | Hopital Robert Schuman | Metz | France | 57070 | |
| 12 | CHU de Nantes - Hôtel Dieu | Nantes | France | 44093 | |
| 13 | Groupe Hospitalier Diaconesses Croix Saint-Simon | Paris | France | 75020 | |
| 14 | CHU Bordeaux - Centre Universitaire Pellegrin | Pessac | France | 33076 | |
| 15 | Maison des consultations - Centre Briochin d'Urologie | Plerin | France | 22190 | |
| 16 | Groupe Courlancy | Reims | France | 51100 | |
| 17 | CH Roubaix | Roubaix | France | 59056 | |
| 18 | CHU Rouen - Hopital Charles Nicolle | Rouen | France | 76031 | |
| 19 | Clinique Urologique Nantes Atlantis | Saint Herblain | France | 44800 | |
| 20 | CH Sarreguemines | Sarreguemines | France | 57211 | |
| 21 | Hopital Civil Strasbourg | Strasbourg | France | 67091 | |
| 22 | Polyclinique Ormeau | Tarbes | France | 65000 | |
| 23 | CHU Toulouse - Hopital Rangueil | Toulouse | France | 31059 | |
| 24 | Clinique Ambroise Pare | Toulouse | France | 31082 |
Sponsors and Collaborators
- MedtronicNeuro
- Medtronic France SAS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.05.7008