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Urinary IncontinenceSOUNDSNCT02186041

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

An observational study of Urinary Incontinence and Over Active Bladder, run by MedtronicNeuro at 24 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacral Nerve Modulation
Type of treatment
Medical device
How many people
320 participants
Where
24 sitesFrance
Study dates
Aug 2014to 22 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Difficulty of collecting follow up patient data;
  • Patient not affiliated to social security.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13616

  • CHIC Alencon Mamers

    Alençon, 61000

  • CHU Angers

    Angers, 49933

  • Hopital Prive Sevigné

    Cesson Sevigné, 35576

  • Clinique Chirurgicale du Pre

    Le Mans, 72018

  • CHRU Lille

    Lille, 59037

  • Clinique Mutualiste de la porte de l'Orient

    Lorient, 56324

  • Clinique Mutualiste de la Porte de lOrient

    Lorient, 56324

  • APM Hopital de La Conception

    Marseille, 13005

  • APHM Hôpital Nord

    Marseille, 13385

  • Hopital Robert Schuman

    Metz, 57070

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75020

  • CHU Bordeaux - Centre Universitaire Pellegrin

    Pessac, 33076

  • Maison des consultations - Centre Briochin d'Urologie

    Plérin, 22190

  • Groupe Courlancy

    Reims, 51100

  • CH Roubaix

    Roubaix, 59056

  • CHU Rouen - Hopital Charles Nicolle

    Rouen, 76031

  • Clinique Urologique Nantes Atlantis

    Saint-Herblain, 44800

  • CH Sarreguemines

    Sarreguemines, 57211

  • Hopital Civil Strasbourg

    Strasbourg, 67091

  • Polyclinique Ormeau

    Tarbes, 65000

  • CHU Toulouse - Hopital Rangueil

    Toulouse, 31059

  • Clinique Ambroise Pare

    Toulouse, 31082

Other trials in France

About this study

Official title: 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.

Being tested
Sacral Nerve Modulation
Medical subject headings
Urinary Incontinence, Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacral Nerve ModulationDevice

    Also called Interstim

Study groups in NCT02186041
Study groupRoleWhat they receive
De-Novo patientsPatients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.
Receives: Device: Sacral Nerve Modulation
Device replacementPatients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.
Receives: Device: Sacral Nerve Modulation
Not-implanted patientsPatients 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
Receives: Device: Sacral Nerve Modulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months

Secondary outcomes (10)

  1. 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.

    Measured: 5 years

  2. Concomitant treatment - Objective #3

    To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.

    Measured: Up to 5 years

  3. 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.

    Measured: Up to 5 years

  4. 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.

    Measured: Up to 5 years

  5. 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.

    Measured: Up to 5 years

  6. Quality of Life (DITROVIE) - Objective#7

    To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.

    Measured: Up to 5 years

  7. Quality of Life (EQ-5D-5L) - Objective#8

    To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.

    Measured: Up to 5 years

  8. 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.

    Measured: Up to 5 years

  9. Goal attainment assessment - Objective#10

    To evaluate the long term goal attainment assessed by the GAS.

    Measured: Up to 5 years

  10. 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion22 Mar 2021
  4. Study completion22 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186041
Sponsor's protocol ID
1.05.7008
Acronym
SOUNDS
Status last verified
Jul 2021
First submitted
4 Jul 2014
Last updated
16 Jul 2021
Results posted
No
Data monitoring committee
No

Publications

  • Chartier-Kastler E, Normand LL, Ruffion A, Saussine C, Braguet R, Rabut B, Ragni E, Perrouin-Verbe MA, Pierrevelcin J, Rousseau T, Game 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. Sacral Neuromodulation with the InterStim System for Overactive Bladder: 3-Year Results from the French Prospective, Multicenter, Observational SOUNDS Study. Eur Urol Focus. 2022 Sep;8(5):1399-1407. doi: 10.1016/j.euf.2021.06.013. Epub 2021 Jul 30.

    PubMed 34334342

  • 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, Game 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. 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. Eur Urol Focus. 2021 Nov;7(6):1430-1437. doi: 10.1016/j.euf.2020.06.026. Epub 2020 Sep 7.

    PubMed 32907782

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Incontinence and Over Active Bladder, run by MedtronicNeuro at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Performance (2 years) - Objective #1 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186041, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.

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SOUNDS Clinical Trial NCT02186041 | AzTrials