<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/NCT02214784</url>
  </required_header>
  <id_info>
    <org_study_id>BMR-11-1002</org_study_id>
    <secondary_id>ISRCTN68358784</secondary_id>
    <nct_id>NCT02214784</nct_id>
  </id_info>
  <brief_title>Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence</brief_title>
  <official_title>A Randomised Controlled Double-Blind Clinical Study To Evaluate The Safety And Performance Of Neuromuscular Electrical Stimulation (NMES) With The Neurotech Vital Device For The Treatment Of Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atlantic Therapeutics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Atlantic Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens&#xD;
      when physical activities such as running, jumping and lifting etc are carried out or when&#xD;
      increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.&#xD;
&#xD;
      There are various treatment options available - surgical operations, pelvic floor&#xD;
      exercises/muscle training and electrical stimulation. This study aims to prove that using the&#xD;
      Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and&#xD;
      tone them and in doing so improving stress urinary incontinence. We are comparing the&#xD;
      Neurotech Vital device with an altered Neurotech Vital device that does not give the same&#xD;
      stimulation treatment. There is a 50% chance of you receiving the altered device, if you do,&#xD;
      you will be offered the non-altered Neurotech vital device after your first 12 week treatment&#xD;
      programme. Both devices are identical in looks, but give different stimulations through the&#xD;
      skin contact electrodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves wearing a device that includes a wired garment around the hip and bottom&#xD;
      area for a period of 30 minutes, 5 days out of 7, for 12 weeks. During this treatment,&#xD;
      electrical stimulation is passed through skin contact electrodes (large sticky black pads)&#xD;
      which causes the pelvic floor to contract and relax, without you having to do anything. This&#xD;
      treatment is not painful and is very similar to the workout you would get from relaxing and&#xD;
      contracting your pelvic floor muscles yourself, however the device produces a much stronger&#xD;
      contraction.&#xD;
&#xD;
      The study is open to females who have failed a 6 week exercise programme and have been&#xD;
      diagnosed with Stress Urinary Incontinence. It will take place at hospital uro-gynaecology&#xD;
      clinics/continence clinics across the United Kingdom. The study could last up to 16 months.&#xD;
&#xD;
      This study is being carried out to further prove that the Neurotech Vital device is an&#xD;
      effective way of treating stress urinary incontinence in female participants.The study will&#xD;
      look at the results of a 12 week treatment programme with the Neurotech Vital device compared&#xD;
      to the modified Neurotech Vital device. It will compare the following:&#xD;
&#xD;
        1. how much urine is lost in a standard 1 minute stress test carried out at the baseline&#xD;
           visit (start of the treatment) right through to visit 5 (end of the treatment - 12&#xD;
           weeks).&#xD;
&#xD;
        2. How much improvement is shown in the quality of life questionnaire (this is measured by&#xD;
           ticking questions which have scores attached to them and adding up the total score for&#xD;
           the questionnaire). This questionnaire asks questions on quality of life which is&#xD;
           affected by stress urinary incontinence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All participants taking part in a standardised 1-minute stress test</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All participants to complete a Quality of life questionnaire (I-QOL)</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>participants taking part in a 1 minute stress test</measure>
    <time_frame>4, 8, 12 and 26 weeks</time_frame>
    <description>We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>participants taking part in a 1-hour pad weight test</measure>
    <time_frame>Stress test done at 4, 8 and 12 weeks during treatment with the device and at 6 months, for the main and cohort part of study</time_frame>
    <description>The loss of urine in grams after this test at the above time points will be collected and using the definition of dryness (pad weight of less than 1 gram) they will be looked at to see if at any of the above timepoints the participants are classed as dry i.e. have urine loss of less than 1gram following the stres test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>particpants taking part in the stress test and then having the pad weight to show loss of urine.</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>We are looking at a significant reduction in the weight of the pad after the stress test has taken place, this improvement is defined as a greater than 50% reduction in pad weight in all particpants who took the test at baseline compared to the weight of the pad at 4, 8 and 12 weeks and at 6months for the main and cohort studies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-hour pad weight test</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months, for main and cohort part of the study</time_frame>
    <description>reduction in pad weight on the 1-hour pad weight test in relation to the mean intensity of the stimulation delivered during the 12-week treatment programme;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life questionnaire</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study</time_frame>
    <description>quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL) (except for the 12 week assessment which is one of the primary endpoints);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life questionnaire</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>quality of life questionnaire assessed using the Kings Health Questionnaire (KHQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour pad weight test</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour pad weight test</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24hour pad weight test</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24-hour pad weight test;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-day diary card</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>number of incontinence episodes/day recorded using a 3-day voiding diary;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-day voiding diary</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>number of pads used/day recorded using a 3-day voiding diary;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Oxford Score</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>pelvic floor strength and quality of contraction measured using the Modified Oxford Score;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor ultrasound</measure>
    <time_frame>4, 8 and 12 weeks and at 6 months for main and cohort part of the study</time_frame>
    <description>pelvic floor muscle function measured using sonographic/real time ultrasound imaging/recording with displacement measurement using on screen callipers on the sonogram unit to assess volitional contractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>participants taking part in a 1 minute stress test</measure>
    <time_frame>We will compare the urine loss against the urine loss after 4weeks treatment with the device and also after 8weeks treatment with the device and 12 weeks treatment</time_frame>
    <description>We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>3-day voiding diary</measure>
    <time_frame>6, 9 and 12 months</time_frame>
    <description>time to achieve dryness (i.e. no record of any leaks) on the 3-day voiding diary;</description>
  </other_outcome>
  <other_outcome>
    <measure>device compliance download</measure>
    <time_frame>6, 9 and 12 months</time_frame>
    <description>compliance with the treatment protocol during the 12-week treatment programme;</description>
  </other_outcome>
  <other_outcome>
    <measure>Device Ease of Use Questionnaire</measure>
    <time_frame>12 weeks cohort and main study</time_frame>
    <description>subject feedback on the device recorded by the Device Ease of Use Questionnaire following completion of the 12-week treatment programme;</description>
  </other_outcome>
  <other_outcome>
    <measure>We will collect from all participants the number of Adverse Events (AEs), Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs) and Uunexpected Adverse Device Events (UADE)and any Device Deficiencies.</measure>
    <time_frame>Screening to 26 weeks</time_frame>
    <description>the safety will be ascertained according to how many participants report any device related adverse events and and device related serious adverse events also we will look at device deficiencies reported by all the participants</description>
  </other_outcome>
  <other_outcome>
    <measure>Participants completing a Quality of life questionnaire</measure>
    <time_frame>scores looked at from the questionnaires completed at 9 months and 12 months</time_frame>
    <description>The scores collected on these questionnaires will be compared against the scores collected at 12 months - The Kings Health Questionnaire and Incontinence Quality of Life Questionnaire (I-QOL)both are completed at 9 months into the study and 12 months.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Active Neurotech Vital Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Neurotech Vital Device</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Neurotech Vital</intervention_name>
    <description>12 weeks treatment for 30 minutes per day, 5 days out of 7.</description>
    <arm_group_label>Active Neurotech Vital Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Modified Neurotech Vital Device</intervention_name>
    <description>12 weeks treatment for 30 minutes per day for 5 days out of 7.</description>
    <arm_group_label>Modified Neurotech Vital Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are female and at least 18 years of age.&#xD;
&#xD;
          -  Subjects who have signed informed consent form prior to any study related activity.&#xD;
&#xD;
          -  Subjects who have previously failed a 6 week volitional pelvic floor muscle training&#xD;
             programme or in the Investigators opinion an equivalent lifestyle and exercise&#xD;
             programme.&#xD;
&#xD;
          -  Subjects who have been clinically diagnosed with stress urinary incontinence and&#xD;
             demonstrate a &gt;4g urine leakage following a standardised 1-minute stress test at 1&#xD;
             hour post-bladder filling protocol (1-hour pad weight test). Stress urinary&#xD;
             incontinence is defined as complaint of involuntary leakage on effort or exertion, or&#xD;
             on sneezing and coughing' (International Continence Society).&#xD;
&#xD;
          -  Subjects who have scored at least 18 out of 27 for the Stress Incontinence Questions&#xD;
             and are confirmed as having predominant stress urinary incontinence on the Medical,&#xD;
             Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire&#xD;
             completed at the screening assessment.&#xD;
&#xD;
          -  Subjects with a Body Mass Index of ≤ 40 kg/m2&#xD;
&#xD;
          -  Subjects who are able to give voluntary, written informed consent to participate in&#xD;
             this study and from whom consent has been obtained.&#xD;
&#xD;
          -  Subjects who are able to understand this study and are willing to complete all the&#xD;
             study assessments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have an existing medical condition that would compromise their&#xD;
             participation in the study.&#xD;
&#xD;
          -  Subjects who have a physical condition that would make them unable to perform the&#xD;
             study procedures.&#xD;
&#xD;
          -  Subjects who have any respiratory condition including a chronic cough or history of&#xD;
             same.&#xD;
&#xD;
          -  Subjects with a history of an underlying neurological condition.&#xD;
&#xD;
          -  Subjects with a history of low back pain involving the spinal nerve root.&#xD;
&#xD;
          -  Subjects who are currently taking medication, or have taken medication in the last 4&#xD;
             weeks, for urinary incontinence or that effect urinary output function including&#xD;
             anti-cholinergics or anti-histamines or any anti-anxiety medications.&#xD;
&#xD;
          -  Subjects with a blood clotting disorder or who are taking anti-coagulant medications.&#xD;
&#xD;
          -  Subjects who have previously had any uro-gynaecological related surgery excluding&#xD;
             hysterectomy.&#xD;
&#xD;
          -  Subjects with a clinical diagnosis of prolapse greater than Stage 2.&#xD;
&#xD;
          -  Subjects who are pregnant or could be pregnant.&#xD;
&#xD;
          -  Subjects who are less than 6 months post-partum or who are lactating.&#xD;
&#xD;
          -  Subjects who have any intra-uterine devices or metal implants in the pelvic area,&#xD;
             including hip and lumbar spine.&#xD;
&#xD;
          -  Subjects with pelvic pain or fibromyalgia or paravaginal defect.&#xD;
&#xD;
          -  Subjects with an active implanted medical device (i.e. pacemaker, pump etc).&#xD;
&#xD;
          -  Subjects with a history of heart disease or stroke.&#xD;
&#xD;
          -  Subjects with a known cancer.&#xD;
&#xD;
          -  Subjects with an injury or disability affecting any part of their body which will be&#xD;
             in contact with the garment.&#xD;
&#xD;
          -  Subjects who are currently involved in any injury litigation claims.&#xD;
&#xD;
          -  Subjects who have participated in a clinical study in the last 3 months or any&#xD;
             previous clinical study with Bio-Medical Research Ltd.&#xD;
&#xD;
          -  Subjects who have been committed to an institution by virtue of an order issued either&#xD;
             by the courts or by an authority.&#xD;
&#xD;
          -  Any vulnerable subjects defined as individuals whose willingness to volunteer in a&#xD;
             clinical study may be unduly influenced by the expectation, whether justified or not,&#xD;
             of benefits associated with participation, or of a retaliatory response from senior&#xD;
             members of a hierarchy in case of refusal to participate. Examples are members of a&#xD;
             group with a hierarchical structure, such as medical, pharmacy, dental and nursing&#xD;
             students, subordinate hospital and laboratory personnel, employees of the&#xD;
             pharmaceutical and medical device industry, members of the armed forces, and persons&#xD;
             kept in detention. Other vulnerable subjects include patients with incurable diseases,&#xD;
             persons in nursing homes, unemployed or impoverished persons, patients in emergency&#xD;
             situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and&#xD;
             those incapable of giving consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R Tunn, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Hedwig Krankenhaus, Berlin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Hedwig Krankenhaus</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Brandenburg,</name>
      <address>
        <city>Brandenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Joesph Hospital,</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 4, 2013</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress urinary Incontinence</keyword>
  <keyword>SUI</keyword>
  <keyword>Continence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT02214784
org study id: BMR-11-1002
secondary id: ISRCTN68358784
nct id: NCT02214784
lead sponsor: 
has dmc: No
Stress Urinary Incontinence (SUI) is described as an uncontrolled loss of urine which happens
      when physical activities such as running, jumping and lifting etc are carried out or when
      increased pressure to the bladder in everyday life is applied by simply sneezing or coughing.

      There are various treatment options available - surgical operations, pelvic floor
      exercises/muscle training and electrical stimulation. This study aims to prove that using the
      Neurotech Vital device for 12 weeks can stimulate the pelvic floor muscles to strengthen and
      tone them and in doing so improving stress urinary incontinence. We are comparing the
      Neurotech Vital device with an altered Neurotech Vital device that does not give the same
      stimulation treatment. There is a 50% chance of you receiving the altered device, if you do,
      you will be offered the non-altered Neurotech vital device after your first 12 week treatment
      programme. Both devices are identical in looks, but give different stimulations through the
      skin contact electrodes.
The study involves wearing a device that includes a wired garment around the hip and bottom
      area for a period of 30 minutes, 5 days out of 7, for 12 weeks. During this treatment,
      electrical stimulation is passed through skin contact electrodes (large sticky black pads)
      which causes the pelvic floor to contract and relax, without you having to do anything. This
      treatment is not painful and is very similar to the workout you would get from relaxing and
      contracting your pelvic floor muscles yourself, however the device produces a much stronger
      contraction.

      The study is open to females who have failed a 6 week exercise programme and have been
      diagnosed with Stress Urinary Incontinence. It will take place at hospital uro-gynaecology
      clinics/continence clinics across the United Kingdom. The study could last up to 16 months.

      This study is being carried out to further prove that the Neurotech Vital device is an
      effective way of treating stress urinary incontinence in female participants.The study will
      look at the results of a 12 week treatment programme with the Neurotech Vital device compared
      to the modified Neurotech Vital device. It will compare the following:

        1. how much urine is lost in a standard 1 minute stress test carried out at the baseline
           visit (start of the treatment) right through to visit 5 (end of the treatment - 12
           weeks).

        2. How much improvement is shown in the quality of life questionnaire (this is measured by
           ticking questions which have scores attached to them and adding up the total score for
           the questionnaire). This questionnaire asks questions on quality of life which is
           affected by stress urinary incontinence.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: All participants taking part in a standardised 1-minute stress test
time frame: 12 weeks
description: We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at baseline and then what it measures at 12 weeks after the 12 weeks treatment with the device. Comparing these against one another to look at any improvement.
measure: All participants to complete a Quality of life questionnaire (I-QOL)
time frame: 12 weeks
description: We will look at the scores which are taken from these questionnaires (depending on which answer is ticked by the participant on the questionnaire) at baseline before treatment with the device commences and then again after 12 weeks of treatment with the device and compare the scores for any improvement.
measure: participants taking part in a 1 minute stress test
time frame: 4, 8, 12 and 26 weeks
description: We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.
measure: participants taking part in a 1-hour pad weight test
time frame: Stress test done at 4, 8 and 12 weeks during treatment with the device and at 6 months, for the main and cohort part of study
description: The loss of urine in grams after this test at the above time points will be collected and using the definition of dryness (pad weight of less than 1 gram) they will be looked at to see if at any of the above timepoints the participants are classed as dry i.e. have urine loss of less than 1gram following the stres test.
measure: particpants taking part in the stress test and then having the pad weight to show loss of urine.
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: We are looking at a significant reduction in the weight of the pad after the stress test has taken place, this improvement is defined as a greater than 50% reduction in pad weight in all particpants who took the test at baseline compared to the weight of the pad at 4, 8 and 12 weeks and at 6months for the main and cohort studies.
measure: 1-hour pad weight test
time frame: 4, 8 and 12 weeks and at 6 months, for main and cohort part of the study
description: reduction in pad weight on the 1-hour pad weight test in relation to the mean intensity of the stimulation delivered during the 12-week treatment programme;
measure: quality of life questionnaire
time frame: 4, 8 and 12 weeks and at 6 months, for main part and cohort part of the study
description: quality of life assessed using the Incontinence Quality of Life Questionnaire (I-QOL) (except for the 12 week assessment which is one of the primary endpoints);
measure: quality of life questionnaire
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: quality of life questionnaire assessed using the Kings Health Questionnaire (KHQ)
measure: 24 hour pad weight test
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: urine leakage experienced by the subject at home during a 24-hour period (24-hour pad weight test);
measure: 24 hour pad weight test
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: dryness, defined as a pad weight of less than 1.3g on the 24-hour pad weight test;
measure: 24hour pad weight test
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: significant improvement, defined as a greater than 50% reduction in pad weight from baseline on the 24-hour pad weight test;
measure: 3-day diary card
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: number of incontinence episodes/day recorded using a 3-day voiding diary;
measure: 3-day voiding diary
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: number of pads used/day recorded using a 3-day voiding diary;
measure: Modified Oxford Score
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: pelvic floor strength and quality of contraction measured using the Modified Oxford Score;
measure: Pelvic floor ultrasound
time frame: 4, 8 and 12 weeks and at 6 months for main and cohort part of the study
description: pelvic floor muscle function measured using sonographic/real time ultrasound imaging/recording with displacement measurement using on screen callipers on the sonogram unit to assess volitional contractions
measure: participants taking part in a 1 minute stress test
time frame: We will compare the urine loss against the urine loss after 4weeks treatment with the device and also after 8weeks treatment with the device and 12 weeks treatment
description: We will look at the amount of urine in grams which is lost by participants when carrying out a stress test with all participants and compare their urine loss measured at 4, 8 and 12 weeks against each other and calculate any difference to ascertain if any improvment has been gained by following the device treatment schedule.
measure: 3-day voiding diary
time frame: 6, 9 and 12 months
description: time to achieve dryness (i.e. no record of any leaks) on the 3-day voiding diary;
measure: device compliance download
time frame: 6, 9 and 12 months
description: compliance with the treatment protocol during the 12-week treatment programme;
measure: Device Ease of Use Questionnaire
time frame: 12 weeks cohort and main study
description: subject feedback on the device recorded by the Device Ease of Use Questionnaire following completion of the 12-week treatment programme;
measure: We will collect from all participants the number of Adverse Events (AEs), Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs) and Uunexpected Adverse Device Events (UADE)and any Device Deficiencies.
time frame: Screening to 26 weeks
description: the safety will be ascertained according to how many participants report any device related adverse events and and device related serious adverse events also we will look at device deficiencies reported by all the participants
measure: Participants completing a Quality of life questionnaire
time frame: scores looked at from the questionnaires completed at 9 months and 12 months
description: The scores collected on these questionnaires will be compared against the scores collected at 12 months - The Kings Health Questionnaire and Incontinence Quality of Life Questionnaire (I-QOL)both are completed at 9 months into the study and 12 months.
arm group label: Active Neurotech Vital Device
arm group type: Active Comparator
description: 50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30minutes over 12 weeks.
arm group label: Modified Neurotech Vital Device
arm group type: Placebo Comparator
description: 50% of 140 patients on a 12 week treatment programme with the device used 5 days out of 7 for 30 minutes over 12 weeks.
intervention type: Device
intervention name: Active Neurotech Vital
description: 12 weeks treatment for 30 minutes per day, 5 days out of 7.
arm group label: Active Neurotech Vital Device
intervention type: Device
intervention name: Modified Neurotech Vital Device
description: 12 weeks treatment for 30 minutes per day for 5 days out of 7.
arm group label: Modified Neurotech Vital Device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: R Tunn, Professor
role: Principal Investigator
affiliation: St Hedwig Krankenhaus, Berlin
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress