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

July 15, 2021 updated by: MedtronicNeuro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Centre Hospitalier du Pays d'Aix
      • Alencon, France, 61000
        • CHIC Alencon Mamers
      • Angers, France, 49933
        • CHU Angers
      • Cesson Sevigné, France, 35576
        • Hôpital privé Sévigné
      • Le Mans, France, 72018
        • Clinique Chirurgicale du Pre
      • Lille, France, 59037
        • CHRU Lille
      • Lorient, France, 56324
        • Clinique Mutualiste de la Porte de l'Orient
      • Lorient, France, 56324
        • Clinique Mutualiste de la Porte de Lorient
      • Marseille, France, 13005
        • APM Hopital de La Conception
      • Marseille, France, 13385
        • APHM Hopital Nord
      • Metz, France, 57070
        • Hopital Robert Schuman
      • Nantes, France, 44093
        • CHU de Nantes - Hotel Dieu
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses Croix Saint-Simon
      • Pessac, France, 33076
        • CHU Bordeaux - Centre Universitaire Pellegrin
      • Plerin, France, 22190
        • Maison des consultations - Centre Briochin d'Urologie
      • Reims, France, 51100
        • Groupe Courlancy
      • Roubaix, France, 59056
        • CH Roubaix
      • Rouen, France, 76031
        • CHU ROUEN - Hôpital Charles Nicolle
      • Saint Herblain, France, 44800
        • Clinique Urologique Nantes Atlantis
      • Sarreguemines, France, 57211
        • CH Sarreguemines
      • Strasbourg, France, 67091
        • Hopital Civil Strasbourg
      • Tarbes, France, 65000
        • Polyclinique Ormeau
      • Toulouse, France, 31082
        • Clinique Ambroise Pare
      • Toulouse, France, 31059
        • CHU Toulouse - Hôpital Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who are eligible for Interstim® therapy for the treatment of intractable urinary voiding dysfunctions will be proposed to participate to the registry in a representative selection of French centers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • Interstim
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:
  • Interstim
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:
  • Interstim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Performance (2 years) - Objective #1
Time Frame: 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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Performance (5 years) - Objective #2
Time Frame: 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.
5 years
Concomitant treatment - Objective #3
Time Frame: Up to 5 years
To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.
Up to 5 years
NRS evaluation - Objective#4
Time Frame: 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.
Up to 5 years
Effect of Therapy in UR patients - Objective #5
Time Frame: 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.
Up to 5 years
Effect of therapy on OAB patients - Objective#6
Time Frame: 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.
Up to 5 years
Quality of Life (DITROVIE) - Objective#7
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.
Up to 5 years
Urinary symptoms (USP) - Objective#9
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
To evaluate the long term goal attainment assessed by the GAS.
Up to 5 years
Assessment of Fecal Incontinence - Objective#11
Time Frame: 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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Collaborators

Medtronic France SAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

March 22, 2021

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

July 4, 2014

First Submitted That Met QC Criteria

July 4, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 15, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.05.7008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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