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

Conditions

Over Active Bladder, Urinary Incontinence, Urinary Retention

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.

Chartier-Kastler E, Normand LL, Ruffion A, Saussine C, Braguet R, Rabut B, Ragni E, Perrouin-Verbe MA, Pierrevelcin J, Rousseau T, Gamé X, Tanneau Y, Dargent F, Biardeau X, Graziana JP, Stoica G, Brassart E, Fourmarier M, Yaghi N, Capon G, Ferchaud J, Berrogain N, Peyrat L, Pecoux F, Bryckaert PE, Melotti A, Abouihia A, Keller DUJ, Cornu JN.

2021-07-307 citations

10.1016/j.euf.2021.06.013

Sacral Neuromodulation with the InterStim™ System for Intractable Lower Urinary Tract Dysfunctions (SOUNDS): Results of Clinical Effectiveness, Quality of Life, Patient-Reported Outcomes and Safety in a French Multicenter Observational Study.

Chartier-Kastler E, Le Normand L, Ruffion A, Dargent F, Braguet R, Saussine C, Tanneau Y, Graziana JP, Ragni E, Rabut B, Rousseau T, Biardeau X, Gamé X, Pierrevelcin J, Brassart E, Fourmarier M, Stoica G, Berrogain N, Yaghi N, Pecoux F, Capon G, Ferchaud J, Peyrat L, Bryckaert PE, Karsenty G, Melotti A, Abouihia A, Keller DUJ, Cornu JN.

2020-09-0711 citations

10.1016/j.euf.2020.06.026

Interventions

DEVICESacral Nerve Modulation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
Quality of Life (DITROVIE) - Objective#7	Up to 5 years	To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.

Countries

France

Outcome results

None listed