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Trial record 1 of 54 for:    SOUNDS neuromodulation
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Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study (SOUNDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186041
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
Medtronic France SAS
Information provided by (Responsible Party):
MedtronicNeuro

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
Urinary Incontinence Over Active Bladder Urinary Retention Device: Sacral Nerve Modulation

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Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS):an Observational Study
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 22, 2021
Actual Study Completion Date : March 22, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Interstim




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Goal attainment assessment - Objective#10 [ Time Frame: Up to 5 years ]
    To evaluate the long term goal attainment assessed by the GAS.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186041


Locations
Show Show 24 study locations
Sponsors and Collaborators
MedtronicNeuro
Medtronic France SAS
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT02186041    
Other Study ID Numbers: 1.05.7008
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Retention
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases