<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02186041</url>
  </required_header>
  <id_info>
    <org_study_id>1.05.7008</org_study_id>
    <nct_id>NCT02186041</nct_id>
  </id_info>
  <brief_title>Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS): an Observational Study</brief_title>
  <acronym>SOUNDS</acronym>
  <official_title>Sacral Neuromodulation With InterStim® Therapy for Intractable Urinary Voiding Dysfunctions (SOUNDS):an Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedtronicNeuro</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic France SAS</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>MedtronicNeuro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to document the safety, the effectiveness, the continued&#xD;
      performance at mid and long term, the morbidity and the percent of surgical revisions of the&#xD;
      Interstim® therapy for up to 5 years in a representative sample of French centers under&#xD;
      real-life conditions of use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Performance (2 years) - Objective #1</measure>
    <time_frame>24 months</time_frame>
    <description>To evaluate the safety of Interstim® therapy and the performance of the Interstim® system in the 2 years following the enrollment.&#xD;
The rate of surgical revisions/explantations of the Interstim® system or any of its parts will be measured.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and Performance (5 years) - Objective #2</measure>
    <time_frame>5 years</time_frame>
    <description>To evaluate the safety of Interstim® therapy and the performance of the Interstim® system in the 5 years following the enrollment.&#xD;
The rate of adverse device events and device deficiencies will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concomitant treatment - Objective #3</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS evaluation - Objective#4</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Therapy in UR patients - Objective #5</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of therapy on OAB patients - Objective#6</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (DITROVIE) - Objective#7</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (EQ-5D-5L) - Objective#8</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms (USP) - Objective#9</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To evaluate the change of urinary symptoms of all patients implanted with Interstim® using the Urinary Symptom Profile (USP) questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal attainment assessment - Objective#10</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To evaluate the long term goal attainment assessed by the GAS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Fecal Incontinence - Objective#11</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To assess the therapy effect on fecal incontinence for subset of patients with double incontinence using the WEXNER fecal incontinence score.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">320</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Over Active Bladder</condition>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>De-Novo patients</arm_group_label>
    <description>Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Device replacement</arm_group_label>
    <description>Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not-implanted patients</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sacral Nerve Modulation</intervention_name>
    <arm_group_label>De-Novo patients</arm_group_label>
    <arm_group_label>Device replacement</arm_group_label>
    <arm_group_label>Not-implanted patients</arm_group_label>
    <other_name>Interstim</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who are eligible for Interstim® therapy for the treatment of intractable&#xD;
        urinary voiding dysfunctions will be proposed to participate to the registry in a&#xD;
        representative selection of French centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is at least 18 years old;&#xD;
&#xD;
          -  Patient signed the Patient Data Release Form;&#xD;
&#xD;
          -  Patient suffering from retention or Over Active Bladder;&#xD;
&#xD;
          -  Patient is eligible for Interstim® system therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficulty of collecting follow up patient data;&#xD;
&#xD;
          -  Patient not affiliated to social security.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier du Pays d'Aix</name>
      <address>
        <city>Aix en Provence</city>
        <zip>13616</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHIC Alencon Mamers</name>
      <address>
        <city>Alencon</city>
        <zip>61000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Prive Sevigné</name>
      <address>
        <city>Cesson Sevigné</city>
        <zip>35576</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Chirurgicale du Pre</name>
      <address>
        <city>Le Mans</city>
        <zip>72018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste de la porte de l'Orient</name>
      <address>
        <city>Lorient</city>
        <zip>56324</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste de la Porte de lOrient</name>
      <address>
        <city>Lorient</city>
        <zip>56324</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APM Hopital de La Conception</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHM Hôpital Nord</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Robert Schuman</name>
      <address>
        <city>Metz</city>
        <zip>57070</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes - Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Diaconesses Croix Saint-Simon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Centre Universitaire Pellegrin</name>
      <address>
        <city>Pessac</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maison des consultations - Centre Briochin d'Urologie</name>
      <address>
        <city>Plerin</city>
        <zip>22190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Courlancy</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Roubaix</name>
      <address>
        <city>Roubaix</city>
        <zip>59056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rouen - Hopital Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Urologique Nantes Atlantis</name>
      <address>
        <city>Saint Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Sarreguemines</name>
      <address>
        <city>Sarreguemines</city>
        <zip>57211</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Civil Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Ormeau</name>
      <address>
        <city>Tarbes</city>
        <zip>65000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse - Hopital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Ambroise Pare</name>
      <address>
        <city>Toulouse</city>
        <zip>31082</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02186041
org study id: 1.05.7008
nct id: NCT02186041
lead sponsor: 
collaborator: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
measure: Safety and Performance (2 years) - Objective #1
time frame: 24 months
description: 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.
measure: Safety and Performance (5 years) - Objective #2
time frame: 5 years
description: 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.
measure: Concomitant treatment - Objective #3
time frame: Up to 5 years
description: To evaluate the use of concomitant treatments or interventions dedicated to intractable urinary voiding dysfunctions.
measure: NRS evaluation - Objective#4
time frame: Up to 5 years
description: 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.
measure: Effect of Therapy in UR patients - Objective #5
time frame: Up to 5 years
description: 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.
measure: Effect of therapy on OAB patients - Objective#6
time frame: Up to 5 years
description: 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.
measure: Quality of Life (DITROVIE) - Objective#7
time frame: Up to 5 years
description: To assess the therapy effect on Quality of Life using the DITROVIE questionnaire.
measure: Quality of Life (EQ-5D-5L) - Objective#8
time frame: Up to 5 years
description: To assess the therapy effect on Quality of Life using the EQ-5D-5L questionnaire.
measure: Urinary symptoms (USP) - Objective#9
time frame: Up to 5 years
description: To evaluate the change of urinary symptoms of all patients implanted with Interstim® using the Urinary Symptom Profile (USP) questionnaire.
measure: Goal attainment assessment - Objective#10
time frame: Up to 5 years
description: To evaluate the long term goal attainment assessed by the GAS.
measure: Assessment of Fecal Incontinence - Objective#11
time frame: Up to 5 years
description: To assess the therapy effect on fecal incontinence for subset of patients with double incontinence using the WEXNER fecal incontinence score.
arm group label: De-Novo patients
description: Patients tested and de novo implanted with Interstim®. These patients will be followed-up for 5 years after the implant visit.
arm group label: Device replacement
description: Patients implanted with Interstim® for a device replacement. These patients will be followed-up for 5 years after the implant visit.
arm group label: Not-implanted patients
description: 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
intervention type: Device
intervention name: Sacral Nerve Modulation
arm group label: De-Novo patients
arm group label: Device replacement
arm group label: Not-implanted patients
other name: Interstim
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Urinary Retention
mesh term: Urinary Bladder, Overactive