<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/NCT02190851</url>
  </required_header>
  <id_info>
    <org_study_id>13 7047 01</org_study_id>
    <secondary_id>13-0147</secondary_id>
    <nct_id>NCT02190851</nct_id>
  </id_info>
  <brief_title>Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome</brief_title>
  <acronym>UROPARKTENS</acronym>
  <official_title>Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was&#xD;
      reported at the congress of the &quot;Société Interdisciplinaire Francophone d'UroDynamique et de&#xD;
      Pelvi-Perinéologie&quot; (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients&#xD;
      with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder.&#xD;
      Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated&#xD;
      with subjective improvement of LUTD assessed with the Patient Global Impression of&#xD;
      Improvement (PGI-I) in 5 of the 6 patients.&#xD;
&#xD;
      In view of the encouraging results of this pilot study, we hypothesize that TENS treatment&#xD;
      may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and&#xD;
      multisystem atrophy (MSA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal objective is to compare the efficacy of transcutaneous electrical nerve&#xD;
      stimulation of the posterior tibial nerve with placebo stimulation, applied 20 minutes daily&#xD;
      for 3 months, in Lower Urinary Tract Disorders (LUTD) in patients with Parkinson's disease or&#xD;
      multisystem atrophy, evaluated using the PGI-I (Patient Global Impression of improvement)&#xD;
      tool.&#xD;
&#xD;
      The secondary objectives are to compare the efficacy of TENS with placebo stimulation on&#xD;
      change before/after 3 months of treatment on:&#xD;
&#xD;
        -  the intensity of urinary symptoms, evaluated using the Patient Global Impression of&#xD;
           Severity (PGI-S) scale&#xD;
&#xD;
        -  the number of voidings in 24 hours, number of episodes of urinary incontinence in 24&#xD;
           hours and maximum bladder capacity, evaluated by a voiding diary over 3 days&#xD;
&#xD;
        -  urinary symptoms, evaluated with the urinary symptom profile (USP) questionnaire&#xD;
&#xD;
        -  quality of life, assessed by the Qualiveen-SF® questionnaire&#xD;
&#xD;
        -  post-void residual volume measured by bladder ultrasound and effect on the development&#xD;
           of infectious complications, by comparing the number of urinary infections over 3 months&#xD;
           in each group.&#xD;
&#xD;
      Lastly, the safety of TENS will be compared with that of placebo stimulation by the&#xD;
      occurrence of adverse events during the 3 months of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">October 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Global Impression of Improvement Score Measure</measure>
    <time_frame>3 months</time_frame>
    <description>The score is measured after 3 months treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient global Impression of severity score measure</measure>
    <time_frame>december 1, 2014</time_frame>
    <description>the patient self-assesses the severity of his lower urinary tract disorders</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>electrical nerve stimulation (TENS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two electrodes are attached around the internal malleolus and connected to the TENS unit, by UROSTIM 2.&#xD;
The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TENS</intervention_name>
    <description>Two electrodes are attached around the internal malleolus and connected to the TENS unit.&#xD;
The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.</description>
    <arm_group_label>electrical nerve stimulation (TENS)</arm_group_label>
    <other_name>UROSTIM 2 by SchwaMedica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established diagnosis of Parkinson disease or multisystem atrophy&#xD;
&#xD;
          -  Refractory lower urinary tract disorders or contra-indications or intolerance to the&#xD;
             usual oral treatments&#xD;
&#xD;
          -  Patient capable of completing the questionnaires&#xD;
&#xD;
          -  Patient whose written informed consent has been obtained&#xD;
&#xD;
          -  Patient registered with a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and breast-feeding&#xD;
&#xD;
          -  Contra-indications to TENS (local skin problems, metal ankle joint replacement,&#xD;
             cardiac pacemaker, peripheral neuropathy, subthalamic deep brain stimulation)&#xD;
&#xD;
          -  Associated neurological disorders (stroke, dementia, multiple sclerosis, spinal cord&#xD;
             lesions, peripheral neuropathy) or urological disorders (bladder outlet obstruction,&#xD;
             cancer, pelvic organ prolapse, interstitial cystitis)&#xD;
&#xD;
          -  Unilateral neurological disability&#xD;
&#xD;
          -  Legally incompetent patient, patient under legal protection&#xD;
&#xD;
          -  Participation in another study during the present study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xavier GAME, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Saint Augustin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33074</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Chenevier</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Poincare</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huriez Hospital</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Lyon</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uiversity hospital</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dubos</name>
      <address>
        <city>Pontoise</city>
        <zip>95300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontchaillou Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHToulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Castel-Lacanal E, Game X, Clanet M, Gasq D, De Boissezon X, Guillotreau J, Bourg V, Viala F, Rischmann P, Marque P. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015 Jan;34(1):32-6. doi: 10.1002/nau.22495. Epub 2013 Sep 23.</citation>
    <PMID>24115110</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urinary disorders</keyword>
  <keyword>Parkinson's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Urologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02190851
org study id: 13 7047 01
secondary id: 13-0147
nct id: NCT02190851
lead sponsor: 
has dmc: No
Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was
      reported at the congress of the "Société Interdisciplinaire Francophone d'UroDynamique et de
      Pelvi-Perinéologie" (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients
      with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder.
      Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated
      with subjective improvement of LUTD assessed with the Patient Global Impression of
      Improvement (PGI-I) in 5 of the 6 patients.

      In view of the encouraging results of this pilot study, we hypothesize that TENS treatment
      may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and
      multisystem atrophy (MSA).
The principal objective is to compare the efficacy of transcutaneous electrical nerve
      stimulation of the posterior tibial nerve with placebo stimulation, applied 20 minutes daily
      for 3 months, in Lower Urinary Tract Disorders (LUTD) in patients with Parkinson's disease or
      multisystem atrophy, evaluated using the PGI-I (Patient Global Impression of improvement)
      tool.

      The secondary objectives are to compare the efficacy of TENS with placebo stimulation on
      change before/after 3 months of treatment on:

        -  the intensity of urinary symptoms, evaluated using the Patient Global Impression of
           Severity (PGI-S) scale

        -  the number of voidings in 24 hours, number of episodes of urinary incontinence in 24
           hours and maximum bladder capacity, evaluated by a voiding diary over 3 days

        -  urinary symptoms, evaluated with the urinary symptom profile (USP) questionnaire

        -  quality of life, assessed by the Qualiveen-SF® questionnaire

        -  post-void residual volume measured by bladder ultrasound and effect on the development
           of infectious complications, by comparing the number of urinary infections over 3 months
           in each group.

      Lastly, the safety of TENS will be compared with that of placebo stimulation by the
      occurrence of adverse events during the 3 months of treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Patient Global Impression of Improvement Score Measure
time frame: 3 months
description: The score is measured after 3 months treatment
measure: Patient global Impression of severity score measure
time frame: december 1, 2014
description: the patient self-assesses the severity of his lower urinary tract disorders
arm group label: electrical nerve stimulation (TENS)
arm group type: Experimental
description: Two electrodes are attached around the internal malleolus and connected to the TENS unit, by UROSTIM 2.
The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.
arm group label: Control group
arm group type: Placebo Comparator
description: The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.
intervention type: Device
intervention name: TENS
description: Two electrodes are attached around the internal malleolus and connected to the TENS unit.
The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.
arm group label: electrical nerve stimulation (TENS)
other name: UROSTIM 2 by SchwaMedica
intervention type: Device
intervention name: Control
description: The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Xavier GAME, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Castel-Lacanal E, Game X, Clanet M, Gasq D, De Boissezon X, Guillotreau J, Bourg V, Viala F, Rischmann P, Marque P. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015 Jan;34(1):32-6. doi: 10.1002/nau.22495. Epub 2013 Sep 23.
PMID: 24115110
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Urologic Diseases
sharing ipd: Undecided