<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/NCT03248362</url>
  </required_header>
  <id_info>
    <org_study_id>15/130/73</org_study_id>
    <nct_id>NCT03248362</nct_id>
  </id_info>
  <brief_title>ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes</brief_title>
  <acronym>ELECTRIC</acronym>
  <official_title>ELECtric Tibial Nerve Stimulation to Reduce Incontinence in Care Homes: ELECTRIC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glasgow Caledonian University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Glasgow Caledonian University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine whether a programme of transcutaneous posterior tibial nerve&#xD;
      stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care&#xD;
      home residents and what the associated costs and consequences are.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary incontinence is a distressing and embarrassing condition that occurs in around 70%&#xD;
      older people who live in nursing or residential care homes. It is common in those who have&#xD;
      dementia as well as those with other medical conditions. Urinary incontinence has a major&#xD;
      impact on an older person's dignity and quality of life and is linked to other health&#xD;
      problems and relationship difficulties. It also affects a person's ability and willingness to&#xD;
      socialise. There are not many options for treatment of urinary incontinence in older people,&#xD;
      especially those with dementia. There are several drugs available but these can have&#xD;
      unpleasant side-effects. Sometimes pelvic floor muscle exercises, or going to the toilet at&#xD;
      regular intervals are tried but these can be difficult to do by those who find it hard to get&#xD;
      around or have memory problems. They are also hard to maintain in the longer term and so&#xD;
      older people who experience bladder leakage usually rely on the use of absorbent pads to hold&#xD;
      the urine, rather than trying to treat the cause of the problem. Transcutaneous posterior&#xD;
      tibial nerve stimulation (TPTNS) involves placing two sticky pads (surface electrodes) on a&#xD;
      person's ankle and connecting these to a small, pocket sized electrical stimulator. This&#xD;
      sends an electric pulse to the nerve near the ankle which also controls the bladder. Each&#xD;
      treatment lasts half an hour and a total of twelve are given over a six week period. The&#xD;
      treatment is similar to a TENS machine which is sometimes used for treating pain. It is a&#xD;
      gentle pulsing and its strength is altered to suit the person and what is comfortable for&#xD;
      them. TPTNS helps people with bladder leakage because it reduces the feeling of sudden&#xD;
      urgency and the need to rush to the toilet and so gives people more warning and more time to&#xD;
      find a toilet before they leak. TPTNS also increases the volume of urine the bladder is able&#xD;
      to hold, so people do not need to empty their bladder as often. TPTNS has been tested in ten&#xD;
      small studies but only one involved older people living in care homes and it only included 30&#xD;
      people. So far the studies have all indicated that TPTNS is safe and acceptable and that it&#xD;
      can help bladder problems. However better quality evidence is needed that it works before it&#xD;
      can be recommended for use in everyday treatment.&#xD;
&#xD;
      In this research the investigators will test TPTNS compared to dummy treatment in 500 people&#xD;
      living in care homes who have urinary incontinence and who wear absorbent pads. The amount of&#xD;
      urine they leak into participants' pads will be measured over a 24 hour period after six&#xD;
      weeks (at the end of the TPTNS treatment programme) and after three and five months. This&#xD;
      will tell the investigators if the treatment works and if it decreases leakage and if so, for&#xD;
      how long. The investigators will ask the older person whether they feel their bladder leakage&#xD;
      has changed and about any impact on their quality of life. The opinions of close family&#xD;
      members and care home staff will be sought regarding whether they think TPTNS has had any&#xD;
      effect on the participant. The investigators are also interested to learn about experiences&#xD;
      of TPTNS, from residents, family and friends and all the staff involved. Costs of providing&#xD;
      this treatment compared to the costs of providing continence care and pads will be determined&#xD;
      and. the best ways to give TPTNS treatment in a care home, long term, will be explored with&#xD;
      the care home staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 29, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>
    <intervention_model_description>A pragmatic, multicentre, placebo controlled randomised parallel group trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants &amp; primary researchers will be blinded to group allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of UI leaked</measure>
    <time_frame>6 weeks post randomisation.</time_frame>
    <description>Volume of UI leaked over a 24 hour period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pad use</measure>
    <time_frame>6, 12 and 18 weeks post randomisation</time_frame>
    <description>Number of pads used in 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PVRU volume</measure>
    <time_frame>6, 12 and 18 weeks post randomisation</time_frame>
    <description>Post-void residual volume of urine scanned in bladder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PBBC</measure>
    <time_frame>6, 12 and 18 weeks post randomisation</time_frame>
    <description>Patient Perception of Bladder Condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FC-PBC</measure>
    <time_frame>6, 12 and 18 weeks post randomisation</time_frame>
    <description>Family Carer Perception of Bladder Condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>S-PBC</measure>
    <time_frame>6, 12 and 18 weeks post randomisation</time_frame>
    <description>Staff Perception of Bladder Condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resident DEMQOL</measure>
    <time_frame>6 and 18 weeks post randomisation</time_frame>
    <description>Resident perception of quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staff DEMQOL</measure>
    <time_frame>6 and 18 weeks post randomisation</time_frame>
    <description>Staff perception of quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RUQ</measure>
    <time_frame>6 and 18 weeks post randomisation.</time_frame>
    <description>Economic evaluation via a resource use questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semi structured interviews with residents, carers and staff regarding the impact of experiences of the TPTNS intervention and any impact on quality of life</measure>
    <time_frame>6 and 12 weeks post randomisation</time_frame>
    <description>Exploration of the experiences of the TPTNS intervention from the perspectives of residents, family carers and care home staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Semi-structured interviews and focus groups with care home staff and managers regarding the potential for integrating TPTNS into routine care within care homes, long-term</measure>
    <time_frame>6-24 weeks post randomisation</time_frame>
    <description>Exploration of the factors affecting intervention implementation in the care home context and optimisation for sustainability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>TPTNS Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcutaneous posterior tibial nerve stimulation (TPTNS) delivered in 30 minute sessions twice weekly over a 6 week period. The tibial nerve, which lies immediately posterior to the medial malleolus will be stimulated electrically using a portable TENS machine and two surface electrodes. The cathode electrode will be positioned behind the medial malleolus and the anode 10cm cephalad to it. Standardised stimulation parameters will be applied at 10 Hz frequency, 200µs-1 pulse width in continuous mode and stimulation intensity (mA-1) will be adjusted on a session-by-session basis according to individual resident comfort levels.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham stimulation comprises low intensity, sub-clinical stimulation of the lateral sub-malleolar area, positioned specifically on the lateral aspect to avoid the tibial nerve, which runs close to the skin surface behind the medial malleolus. The stimulation parameters are identical to the TPTNS stimulation other than the intensity of the current which will be set at 4mA, rather than adjusted individually as it is in the TPTNS intervention group. The current will be initially increased until the resident reports feeling some sensation following which the current will be reduced down to 4mA. All residents will be informed that they may not feel anything with this intervention and that this is quite normal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous posterior tibial nerve stimulation</intervention_name>
    <description>12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation</description>
    <arm_group_label>TPTNS Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham stimulation</intervention_name>
    <description>12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area</description>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Care home residents:&#xD;
&#xD;
               -  with self or staff reported UI of more than once/week&#xD;
&#xD;
               -  who use the toilet or toilet aid for bladder evacuation with or without&#xD;
                  assistance&#xD;
&#xD;
               -  who wear absorbent pads to contain UI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Care home residents:&#xD;
&#xD;
               -  with an indwelling urinary catheter&#xD;
&#xD;
               -  residents with UTI&#xD;
&#xD;
               -  residents with PVRU volume more than 300ml&#xD;
&#xD;
               -  residents with a cardiac pacemaker&#xD;
&#xD;
               -  residents with treated epilepsy&#xD;
&#xD;
               -  residents with bilateral leg ulcers&#xD;
&#xD;
               -  residents with pelvic cancer&#xD;
&#xD;
               -  residents on the palliative care register&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Booth, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Glasgow Caledonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glasgow Caledonian University</name>
      <address>
        <city>Glasgow</city>
        <zip>G4 0BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.</citation>
    <PMID>23206722</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03248362
org study id: 15/130/73
nct id: NCT03248362
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to determine whether a programme of transcutaneous posterior tibial nerve
      stimulation (TPTNS) is a clinically effective treatment for urinary incontinence (UI) in care
      home residents and what the associated costs and consequences are.
Urinary incontinence is a distressing and embarrassing condition that occurs in around 70%
      older people who live in nursing or residential care homes. It is common in those who have
      dementia as well as those with other medical conditions. Urinary incontinence has a major
      impact on an older person's dignity and quality of life and is linked to other health
      problems and relationship difficulties. It also affects a person's ability and willingness to
      socialise. There are not many options for treatment of urinary incontinence in older people,
      especially those with dementia. There are several drugs available but these can have
      unpleasant side-effects. Sometimes pelvic floor muscle exercises, or going to the toilet at
      regular intervals are tried but these can be difficult to do by those who find it hard to get
      around or have memory problems. They are also hard to maintain in the longer term and so
      older people who experience bladder leakage usually rely on the use of absorbent pads to hold
      the urine, rather than trying to treat the cause of the problem. Transcutaneous posterior
      tibial nerve stimulation (TPTNS) involves placing two sticky pads (surface electrodes) on a
      person's ankle and connecting these to a small, pocket sized electrical stimulator. This
      sends an electric pulse to the nerve near the ankle which also controls the bladder. Each
      treatment lasts half an hour and a total of twelve are given over a six week period. The
      treatment is similar to a TENS machine which is sometimes used for treating pain. It is a
      gentle pulsing and its strength is altered to suit the person and what is comfortable for
      them. TPTNS helps people with bladder leakage because it reduces the feeling of sudden
      urgency and the need to rush to the toilet and so gives people more warning and more time to
      find a toilet before they leak. TPTNS also increases the volume of urine the bladder is able
      to hold, so people do not need to empty their bladder as often. TPTNS has been tested in ten
      small studies but only one involved older people living in care homes and it only included 30
      people. So far the studies have all indicated that TPTNS is safe and acceptable and that it
      can help bladder problems. However better quality evidence is needed that it works before it
      can be recommended for use in everyday treatment.

      In this research the investigators will test TPTNS compared to dummy treatment in 500 people
      living in care homes who have urinary incontinence and who wear absorbent pads. The amount of
      urine they leak into participants' pads will be measured over a 24 hour period after six
      weeks (at the end of the TPTNS treatment programme) and after three and five months. This
      will tell the investigators if the treatment works and if it decreases leakage and if so, for
      how long. The investigators will ask the older person whether they feel their bladder leakage
      has changed and about any impact on their quality of life. The opinions of close family
      members and care home staff will be sought regarding whether they think TPTNS has had any
      effect on the participant. The investigators are also interested to learn about experiences
      of TPTNS, from residents, family and friends and all the staff involved. Costs of providing
      this treatment compared to the costs of providing continence care and pads will be determined
      and. the best ways to give TPTNS treatment in a care home, long term, will be explored with
      the care home staff.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A pragmatic, multicentre, placebo controlled randomised parallel group trial
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participants & primary researchers will be blinded to group allocation
measure: Volume of UI leaked
time frame: 6 weeks post randomisation.
description: Volume of UI leaked over a 24 hour period
measure: Pad use
time frame: 6, 12 and 18 weeks post randomisation
description: Number of pads used in 24 hours
measure: PVRU volume
time frame: 6, 12 and 18 weeks post randomisation
description: Post-void residual volume of urine scanned in bladder
measure: PBBC
time frame: 6, 12 and 18 weeks post randomisation
description: Patient Perception of Bladder Condition
measure: FC-PBC
time frame: 6, 12 and 18 weeks post randomisation
description: Family Carer Perception of Bladder Condition
measure: S-PBC
time frame: 6, 12 and 18 weeks post randomisation
description: Staff Perception of Bladder Condition
measure: Resident DEMQOL
time frame: 6 and 18 weeks post randomisation
description: Resident perception of quality of life
measure: Staff DEMQOL
time frame: 6 and 18 weeks post randomisation
description: Staff perception of quality of life
measure: RUQ
time frame: 6 and 18 weeks post randomisation.
description: Economic evaluation via a resource use questionnaire
measure: Semi structured interviews with residents, carers and staff regarding the impact of experiences of the TPTNS intervention and any impact on quality of life
time frame: 6 and 12 weeks post randomisation
description: Exploration of the experiences of the TPTNS intervention from the perspectives of residents, family carers and care home staff.
measure: Semi-structured interviews and focus groups with care home staff and managers regarding the potential for integrating TPTNS into routine care within care homes, long-term
time frame: 6-24 weeks post randomisation
description: Exploration of the factors affecting intervention implementation in the care home context and optimisation for sustainability
arm group label: TPTNS Intervention
arm group type: Experimental
description: Transcutaneous posterior tibial nerve stimulation (TPTNS) delivered in 30 minute sessions twice weekly over a 6 week period. The tibial nerve, which lies immediately posterior to the medial malleolus will be stimulated electrically using a portable TENS machine and two surface electrodes. The cathode electrode will be positioned behind the medial malleolus and the anode 10cm cephalad to it. Standardised stimulation parameters will be applied at 10 Hz frequency, 200µs-1 pulse width in continuous mode and stimulation intensity (mA-1) will be adjusted on a session-by-session basis according to individual resident comfort levels.
arm group label: Sham stimulation
arm group type: Sham Comparator
description: Sham stimulation comprises low intensity, sub-clinical stimulation of the lateral sub-malleolar area, positioned specifically on the lateral aspect to avoid the tibial nerve, which runs close to the skin surface behind the medial malleolus. The stimulation parameters are identical to the TPTNS stimulation other than the intensity of the current which will be set at 4mA, rather than adjusted individually as it is in the TPTNS intervention group. The current will be initially increased until the resident reports feeling some sensation following which the current will be reduced down to 4mA. All residents will be informed that they may not feel anything with this intervention and that this is quite normal.
intervention type: Device
intervention name: Transcutaneous posterior tibial nerve stimulation
description: 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation
arm group label: TPTNS Intervention
intervention type: Device
intervention name: Sham stimulation
description: 12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area
arm group label: Sham stimulation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Joanne Booth, Prof
role: Principal Investigator
affiliation: Glasgow Caledonian University
facility: 
country: United Kingdom
citation: Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.
PMID: 23206722
responsible party type: Sponsor
mesh term: Urinary Incontinence
sharing ipd: No