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Completed

NCT Number: NCT02186041

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Over Active Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sacral nerve modulation

Device

Other names: Interstim

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Collaborators

  • Medtronic France SAS

Registry information

Official study title

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

Acronym: SOUNDS

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2014
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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