<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/NCT02239796</url>
  </required_header>
  <id_info>
    <org_study_id>TSA 2013/05</org_study_id>
    <nct_id>NCT02239796</nct_id>
  </id_info>
  <brief_title>Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence</brief_title>
  <acronym>TREAT-UI</acronym>
  <official_title>A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glasgow Caledonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Stroke Association, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Central Lancashire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nursing, Midwifery &amp; Allied Health Professions Research Unit</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS Greater Glasgow and Clyde</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NHS Lanarkshire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glasgow Caledonian University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To aim of this study is to establish the feasibility of undertaking a phase III trial of&#xD;
      transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate&#xD;
      stroke-related urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors.&#xD;
      It is associated with significant burden including reduced quality of life, increased&#xD;
      morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms&#xD;
      (frequency, urgency, nocturia), is most commonly experienced. Current continence care is&#xD;
      limited to lifestyle advice and behavioural interventions such as voiding programmes. There&#xD;
      is a reliance on containment approaches and a lack of available options for active treatment.&#xD;
      Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for&#xD;
      treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population.&#xD;
      This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of&#xD;
      TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be&#xD;
      randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a&#xD;
      programme of TPTNS over a six week period. Bladder function, associated healthcare costs and&#xD;
      quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation&#xD;
      will be conducted. Pilot RCT and process evaluation results will inform the design of a phase&#xD;
      III RCT of TPTNS to treat urinary incontinence in the stroke population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of reported episodes of urinary incontinence as a measure of effectiveness.</measure>
    <time_frame>Up to 16 months</time_frame>
    <description>Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF).&#xD;
This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in the severity of urinary incontinence episodes experienced.</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events as a measure of safety and tolerability.</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in severity of urinary urgency, frequency and nocturia.</measure>
    <time_frame>Up to 16 months</time_frame>
    <description>By completion of AUASI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary symptoms experienced on the American Urological Association Symptom Index</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Urgency Perception Scores recorded on a 3 day bladder diary</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Perception of Bladder Condition</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of bowel symptoms</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Perception of Bowel Condition</measure>
    <time_frame>up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in post-void residual urine volume.</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of urine leakage in 24 hours</measure>
    <time_frame>Up to 16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants perception of independence from any help with activities of daily living</measure>
    <time_frame>Up to 16 months</time_frame>
    <description>Measured by completion of the Barthel Index Score and Modified Rankin Score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Stroke</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>TPTNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator.&#xD;
Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TPTNS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator.&#xD;
The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve.&#xD;
The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuroTrac continence stimulators</intervention_name>
    <description>Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.&#xD;
Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators.</description>
    <arm_group_label>TPTNS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NeuroTrac continence stimulators</intervention_name>
    <description>We are using NeuroTrac continence stimulators.</description>
    <arm_group_label>Sham TPTNS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria&#xD;
             (WHO 1989) and stroke-related urinary incontinence of at least once weekly.&#xD;
&#xD;
          -  Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home&#xD;
             following a new stroke episode within the previous 6 months.&#xD;
&#xD;
          -  Physically, cognitively and communicatively able and willing to learn to apply TPTNS&#xD;
             or has carer who is able and willing to learn.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing urinary incontinence prior to stroke.&#xD;
&#xD;
          -  Current Urinary Tract Infection.&#xD;
&#xD;
          -  Voiding dysfunction requiring intermittent/indwelling catheterisation.&#xD;
&#xD;
          -  Cardiac pacemaker in situ.&#xD;
&#xD;
          -  Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic&#xD;
             neuropathy.&#xD;
&#xD;
          -  Reduced/absent sensation at electrode placement sites.&#xD;
&#xD;
          -  Post-void residual urine volume of &gt; 150ml.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Booth</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glasgow Caledonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NHS Ayrshire and Arran</name>
      <address>
        <city>Ayrshire</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lanarkshire</name>
      <address>
        <city>Glasgow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>May 25, 2016</last_update_submitted>
  <last_update_submitted_qc>May 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transcutaneous posterior tibial nerve stimulation</keyword>
  <keyword>Randomised controlled trial</keyword>
  <keyword>Feasibility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</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/NCT02239796
org study id: TSA 2013/05
nct id: NCT02239796
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
To aim of this study is to establish the feasibility of undertaking a phase III trial of
      transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate
      stroke-related urinary incontinence.
Stroke-related urinary incontinence (UI) persists in more than one third of stroke survivors.
      It is associated with significant burden including reduced quality of life, increased
      morbidity and disability. Urgency UI, together with overactive bladder (OAB) symptoms
      (frequency, urgency, nocturia), is most commonly experienced. Current continence care is
      limited to lifestyle advice and behavioural interventions such as voiding programmes. There
      is a reliance on containment approaches and a lack of available options for active treatment.
      Intermittent electrical stimulation of the posterior tibial nerve (TPTNS) is effective for
      treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population.
      This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of
      TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be
      randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a
      programme of TPTNS over a six week period. Bladder function, associated healthcare costs and
      quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation
      will be conducted. Pilot RCT and process evaluation results will inform the design of a phase
      III RCT of TPTNS to treat urinary incontinence in the stroke population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Frequency of reported episodes of urinary incontinence as a measure of effectiveness.
time frame: Up to 16 months
description: Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF).
This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.
measure: Changes in the severity of urinary incontinence episodes experienced.
time frame: Up to 16 months
measure: Number of participants with adverse events as a measure of safety and tolerability.
time frame: Up to 16 months
measure: Changes in severity of urinary urgency, frequency and nocturia.
time frame: Up to 16 months
description: By completion of AUASI
measure: Urinary symptoms experienced on the American Urological Association Symptom Index
time frame: Up to 16 months
measure: Mean Urgency Perception Scores recorded on a 3 day bladder diary
time frame: Up to 16 months
measure: Patient Perception of Bladder Condition
time frame: Up to 16 months
measure: Severity of bowel symptoms
time frame: Up to 16 months
measure: Patient Perception of Bowel Condition
time frame: up to 16 months
measure: Changes in post-void residual urine volume.
time frame: Up to 16 months
measure: Amount of urine leakage in 24 hours
time frame: Up to 16 months
measure: Participants perception of independence from any help with activities of daily living
time frame: Up to 16 months
description: Measured by completion of the Barthel Index Score and Modified Rankin Score.
arm group label: TPTNS
arm group type: Experimental
description: 12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator.
Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps.
arm group label: Sham TPTNS
arm group type: Sham Comparator
description: The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator.
The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve.
The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided.
intervention type: Device
intervention name: NeuroTrac continence stimulators
description: Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.
Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators.
arm group label: TPTNS
intervention type: Device
intervention name: NeuroTrac continence stimulators
description: We are using NeuroTrac continence stimulators.
arm group label: Sham TPTNS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne Booth
role: Principal Investigator
affiliation: Glasgow Caledonian University
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stroke
mesh term: Urinary Incontinence
mesh term: Enuresis