<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/NCT03296462</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00066652</org_study_id>
    <nct_id>NCT03296462</nct_id>
  </id_info>
  <brief_title>Hip External Rotation Physical Therapy Trial</brief_title>
  <acronym>HER-Physio</acronym>
  <official_title>Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Physiotherapy Alberta - College + Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</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 RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology&#xD;
      Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the&#xD;
      study procedures and follow-up schedule for participants.&#xD;
&#xD;
      The study interventions used in the feasibility study will be training of (1) Hip Extension&#xD;
      Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle&#xD;
      (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy&#xD;
      practice for the treatment of stress urinary incontinence (SUI) despite little evidence&#xD;
      compared to the proven effective standard of care treatment, pelvic floor muscle (PFM)&#xD;
      exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise&#xD;
      alone or in combination with PFM is more or less effective than PFM exercises alone.&#xD;
&#xD;
      Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole&#xD;
      Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to&#xD;
      the proposed RCT, and to test the study procedures and follow-up schedule for participants.&#xD;
&#xD;
      Interventions: The interventions used in the feasibility study will be training of (1) HER&#xD;
      exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises&#xD;
      alone (control/usual care) in the treatment of SUI.&#xD;
&#xD;
      Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.&#xD;
&#xD;
      Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training,&#xD;
      appropriateness of outcome measures and completion rates. The design of the proposed RCT will&#xD;
      be based on these feasibility outcomes.&#xD;
&#xD;
      Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip&#xD;
      rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of&#xD;
      life, and (to test patient mobility) six minute walk test and timed up and go test.&#xD;
&#xD;
      Sample size: The proposed sample size is 30 participants. Duration of study: After&#xD;
      recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at&#xD;
      the end of that period, and a further follow up at 24 weeks from recruitment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 3, 2016</start_date>
  <completion_date type="Actual">July 10, 2019</completion_date>
  <primary_completion_date type="Actual">July 10, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Patient and research assistant are blind to next allocation. Outcome assessors (physiotherapist and exercise physiologist) and one investigator are blinded to group of allocation. Statistician will be masked to group of allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility: achieve recruitment of 30 women over 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Is recruitment feasible? &quot;Feasibility&quot; is defined as achieving recruitment target of 30 recruits within 12 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility: achieve follow-up for 60% of recruits over 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Is follow-up complete for 60% of recruits?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pelvic floor muscle strength</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>Strength will be measured using Peritron perineometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External hip rotator muscle strength</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>Strength will be measured using Microfit ET3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diary-reported urinary incontinence</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>3-day bladder diary to record amount and reason for leakage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence-related quality of life (distress)</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence-related quality of life (impact)</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient mobility (walking)</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>Six minute walk test - distance walked (metres)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient mobility</measure>
    <time_frame>12 &amp; 24 weeks</time_frame>
    <description>&quot;timed up and go&quot; test - time in sconds</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Urinary Incontinence, Stress</condition>
  <arm_group>
    <arm_group_label>Hip external rotation exercise (alone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardised hip external rotation exercise training - over 12 week period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hip external rotation + PFM exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pelvic floor muscle exercises (alone)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standardised pelvic floor muscle exercises - over 12 week period (usual care)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hip external rotation exercise</intervention_name>
    <description>Standardised HER exercise training by physiotherapist (plus video recording of exercises)</description>
    <arm_group_label>Hip external rotation + PFM exercises</arm_group_label>
    <arm_group_label>Hip external rotation exercise (alone)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pelvic floor muscle exercise</intervention_name>
    <description>Standardised PFM exercise training by physiotherapist (plus video recording of exercises)</description>
    <arm_group_label>Hip external rotation + PFM exercises</arm_group_label>
    <arm_group_label>pelvic floor muscle exercises (alone)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stress urinary incontinence&#xD;
&#xD;
          -  Attending Lois Hole Hospital for Women Urogynecology Clinic&#xD;
&#xD;
          -  Referred for physiotherapy for stress urinary incontinence&#xD;
&#xD;
          -  Able to toilet independently&#xD;
&#xD;
          -  Able to undertake hip rotation exercises&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urge urinary incontinence&#xD;
&#xD;
          -  Using a pessary&#xD;
&#xD;
          -  Neurological or cognitive impairment&#xD;
&#xD;
          -  Using other treatment for incontinence&#xD;
&#xD;
          -  Unable to complete study forms&#xD;
&#xD;
          -  Unable to understand educational instruction&#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>Sue Ross, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lois Hole Hospital for Women, Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</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/NCT03296462
org study id: Pro00066652
nct id: NCT03296462
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology
      Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the
      study procedures and follow-up schedule for participants.

      The study interventions used in the feasibility study will be training of (1) Hip Extension
      Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle
      (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy
      practice for the treatment of stress urinary incontinence (SUI) despite little evidence
      compared to the proven effective standard of care treatment, pelvic floor muscle (PFM)
      exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise
      alone or in combination with PFM is more or less effective than PFM exercises alone.

      Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole
      Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to
      the proposed RCT, and to test the study procedures and follow-up schedule for participants.

      Interventions: The interventions used in the feasibility study will be training of (1) HER
      exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises
      alone (control/usual care) in the treatment of SUI.

      Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.

      Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training,
      appropriateness of outcome measures and completion rates. The design of the proposed RCT will
      be based on these feasibility outcomes.

      Outcome measures for the proposed RCT will include pelvic floor muscle strength, external hip
      rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of
      life, and (to test patient mobility) six minute walk test and timed up and go test.

      Sample size: The proposed sample size is 30 participants. Duration of study: After
      recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at
      the end of that period, and a further follow up at 24 weeks from recruitment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Patient and research assistant are blind to next allocation. Outcome assessors (physiotherapist and exercise physiologist) and one investigator are blinded to group of allocation. Statistician will be masked to group of allocation.
measure: Feasibility: achieve recruitment of 30 women over 12 months
time frame: 12 months
description: Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months
measure: Feasibility: achieve follow-up for 60% of recruits over 12 months
time frame: 12 months
description: Is follow-up complete for 60% of recruits?
measure: Pelvic floor muscle strength
time frame: 12 & 24 weeks
description: Strength will be measured using Peritron perineometer
measure: External hip rotator muscle strength
time frame: 12 & 24 weeks
description: Strength will be measured using Microfit ET3
measure: Diary-reported urinary incontinence
time frame: 12 & 24 weeks
description: 3-day bladder diary to record amount and reason for leakage
measure: Incontinence-related quality of life (distress)
time frame: 12 & 24 weeks
description: UDI-6 questionnaire (measure of distress caused by incontinence, 0 minimum to 100 maximum)
measure: Incontinence-related quality of life (impact)
time frame: 12 & 24 weeks
description: IIQ-7 questionnaire (measure of impact of incontinence, 0 minimum to 100 maximum)
measure: Patient mobility (walking)
time frame: 12 & 24 weeks
description: Six minute walk test - distance walked (metres)
measure: Patient mobility
time frame: 12 & 24 weeks
description: "timed up and go" test - time in sconds
arm group label: Hip external rotation exercise (alone)
arm group type: Experimental
description: Standardised hip external rotation exercise training - over 12 week period
arm group label: Hip external rotation + PFM exercises
arm group type: Experimental
description: Standardised hip external rotation plus pelvic floor muscle exercises - over 12 week period
arm group label: pelvic floor muscle exercises (alone)
arm group type: Active Comparator
description: Standardised pelvic floor muscle exercises - over 12 week period (usual care)
intervention type: Other
intervention name: Hip external rotation exercise
description: Standardised HER exercise training by physiotherapist (plus video recording of exercises)
arm group label: Hip external rotation + PFM exercises
arm group label: Hip external rotation exercise (alone)
intervention type: Other
intervention name: Pelvic floor muscle exercise
description: Standardised PFM exercise training by physiotherapist (plus video recording of exercises)
arm group label: Hip external rotation + PFM exercises
arm group label: pelvic floor muscle exercises (alone)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sue Ross, PhD
role: Study Director
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided