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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02186041
Other study ID # 1.05.7008
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2014
Est. completion date March 22, 2021

Study information

Verified date July 2021
Source MedtronicNeuro
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date March 22, 2021
Est. primary completion date March 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
Sacral Nerve Modulation


Locations

Country Name City State
France Centre Hospitalier du Pays d'Aix Aix en Provence
France CHIC Alencon Mamers Alencon
France CHU Angers Angers
France Hopital Prive Sevigné Cesson Sevigné
France Clinique Chirurgicale du Pre Le Mans
France CHRU Lille Lille
France Clinique Mutualiste de la porte de l'Orient Lorient
France Clinique Mutualiste de la Porte de lOrient Lorient
France APHM Hôpital Nord Marseille
France APM Hopital de La Conception Marseille
France Hopital Robert Schuman Metz
France CHU de Nantes - Hôtel Dieu Nantes
France Groupe Hospitalier Diaconesses Croix Saint-Simon Paris
France CHU Bordeaux - Centre Universitaire Pellegrin Pessac
France Maison des consultations - Centre Briochin d'Urologie Plerin
France Groupe Courlancy Reims
France CH Roubaix Roubaix
France CHU Rouen - Hopital Charles Nicolle Rouen
France Clinique Urologique Nantes Atlantis Saint Herblain
France CH Sarreguemines Sarreguemines
France Hopital Civil Strasbourg Strasbourg
France Polyclinique Ormeau Tarbes
France CHU Toulouse - Hopital Rangueil Toulouse
France Clinique Ambroise Pare Toulouse

Sponsors (2)

Lead Sponsor Collaborator
MedtronicNeuro Medtronic France SAS

Country where clinical trial is conducted

France, 

Outcome

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