<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/NCT02233608</url>
  </required_header>
  <id_info>
    <org_study_id>D2014-20</org_study_id>
    <nct_id>NCT02233608</nct_id>
  </id_info>
  <brief_title>Advanced Pelvic Floor Training Program for Prostate Cancer Surgery</brief_title>
  <acronym>AFPX</acronym>
  <official_title>A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Guelph-Humber</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Princess Margaret Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Guelph-Humber</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radical prostatectomy is a common and effective treatment for prostate cancer but is&#xD;
      associated with urinary incontinence that can persist for several months after surgery and&#xD;
      significantly reduce quality of life. Studies have shown that routine performance of pelvic&#xD;
      floor exercises after radical prostatectomy can aid in the recovery of urinary control;&#xD;
      however, conventional pelvic floor exercises do not produce consistent results. Research&#xD;
      indicates that incorporating other deep abdominal muscles can further activate the pelvic&#xD;
      floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'&#xD;
      and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises&#xD;
      with activation of supportive muscles. Our proposed study will be the first to test the&#xD;
      effect of an advanced pelvic floor exercise training program that includes Pfilates and&#xD;
      Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim&#xD;
      of this study is to assess the feasibility of conducting a full-scale RCT of an advanced&#xD;
      pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,&#xD;
      and Hypopressives techniques on urinary incontinence. Feasibility will be determined by&#xD;
      measuring recruitment success, retention, outcome capture, and intervention adherence,&#xD;
      tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate&#xD;
      cancer in the advance pelvic floor training program will report greater improvement in&#xD;
      urinary incontinence and health-related quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">September 28, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>When recruitment is complete (approximately 12 months after study initiation; October 2015)</time_frame>
    <description>Prior pelvic floor training trials in prostate cancer patients undergoing radical prostatectomy have observed recruitment rates of 21-70%. We will measure recruitment success through participant recruitment per week and record reasons for non-participation from those who inquire about the study and are eligible to participate but refuse.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to intervention group</measure>
    <time_frame>26 weeks post-operatively</time_frame>
    <description>Adherence to the two groups (standard pelvic floor exercises and advanced pelvic floor exercises) will be measured through a logbook that is included in their respective program manuals as well as a logbook completed by the research coordinator during the weekly telephone communications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study retention</measure>
    <time_frame>26 weeks post-operative</time_frame>
    <description>Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour Pad Test for Urinary Leakage</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively</time_frame>
    <description>A 24-hour pad test will be used to measure urinary incontinence by assessing the quantity of urine lost in one day. A urinary leakage pad is measured after a 24-hour period and compared to the unused pad weight and is used to most accurately assess the severity of urinary incontinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic Floor Strength</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively</time_frame>
    <description>Digital rectal examination of pelvic floor strength by a specially trained pelvic floor physiotherapist will be conducted. Pelvic floor strength will be graded on the Modified Oxford Scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative</time_frame>
    <description>Prostate specific quality of life will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-Day Bladder Diary for Urinary Incontinence</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively</time_frame>
    <description>The bladder diary is a standard instrument for self-reporting voiding patterns. Items include fluid intake, frequency of toilet voids, episode of urine loss, number of pads used, and activity during event for the three-day period. Bladder diaries are widely used in clinical trials assessing urinary incontinence after radical prostatectomy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively</time_frame>
    <description>Urological symptoms are assessed using the International Prostate Symptom Score (IPSS). Additional, a single item regarding leaking urine and bladder control from the PORPUS will be used to evaluate incontinence. Erectile function will be assessed using the 5-item International Index of Erectile Function scale (5-IIEF).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively</time_frame>
    <description>Body composition will be assessed via bioelectrical impedance analysis, height, weight, waist and hip circumference, and body mass index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively</time_frame>
    <description>Physical activity level will be measured wight he 3-item Godin Leisure Time Exercise Questionnaire - Leisure Score Index (GLTEQ-LSI).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Prostate Cancer Patients Undergoing Radical Prostatectomy</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The usual care group will receive generic pelvic floor muscle exercise (PMFX) instructions and demonstrations by the research coordinator at the initial post-operative time point. This will include instruction on how to engage the pelvic floor and specific PFMX prescription. Repetition volume will start at 20 repetitions per day during weeks 1-2; 60/day during weeks 3-4; and 90/day during weeks 5-6, and 100+/day for weeks 7-26. The total number of repetitions will be divided equally between rhythmic (contract and relaxed over one second) and sustained contractions (contract and hold for up to 10 seconds).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Advanced Pelvic Floor Exercise (APFX)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive detailed week-by-week description of the program. The program progresses participants through stages of training every two weeks, starting the introduction of basic PFMX, and slowly incorporates Pfilates and Hypopressives exercises until week 8, where patients will maintain the final stage of training until week 26 or urinary incontinence is completely resolved.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Advanced Pelvic Floor Muscle Exercise (APFX)</intervention_name>
    <arm_group_label>Advanced Pelvic Floor Exercise (APFX)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with localized prostate cancer (stage cT1-cT2) who have consented for radical&#xD;
             prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)&#xD;
&#xD;
          -  Between the the ages of 40 and 80 years&#xD;
&#xD;
          -  Proficient in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;&#xD;
&#xD;
          -  ii) Have prior experience with pelvic floor training by a healthcare provider;&#xD;
&#xD;
          -  iii) Have uncontrolled hypertension;&#xD;
&#xD;
          -  iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic&#xD;
             restrictive respiratory disease; or&#xD;
&#xD;
          -  v) Have a history of inguinal herniation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Daniel Santa Mina</investigator_full_name>
    <investigator_title>Scientist</investigator_title>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Radical prostatectomy</keyword>
  <keyword>Pelvic floor muscle exercises</keyword>
  <keyword>Pfilates</keyword>
  <keyword>Hypopressives</keyword>
  <keyword>Urinary Incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02233608
org study id: D2014-20
nct id: NCT02233608
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Radical prostatectomy is a common and effective treatment for prostate cancer but is
      associated with urinary incontinence that can persist for several months after surgery and
      significantly reduce quality of life. Studies have shown that routine performance of pelvic
      floor exercises after radical prostatectomy can aid in the recovery of urinary control;
      however, conventional pelvic floor exercises do not produce consistent results. Research
      indicates that incorporating other deep abdominal muscles can further activate the pelvic
      floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates'
      and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises
      with activation of supportive muscles. Our proposed study will be the first to test the
      effect of an advanced pelvic floor exercise training program that includes Pfilates and
      Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim
      of this study is to assess the feasibility of conducting a full-scale RCT of an advanced
      pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates,
      and Hypopressives techniques on urinary incontinence. Feasibility will be determined by
      measuring recruitment success, retention, outcome capture, and intervention adherence,
      tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate
      cancer in the advance pelvic floor training program will report greater improvement in
      urinary incontinence and health-related quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Recruitment
time frame: When recruitment is complete (approximately 12 months after study initiation; October 2015)
description: Prior pelvic floor training trials in prostate cancer patients undergoing radical prostatectomy have observed recruitment rates of 21-70%. We will measure recruitment success through participant recruitment per week and record reasons for non-participation from those who inquire about the study and are eligible to participate but refuse.
measure: Adherence to intervention group
time frame: 26 weeks post-operatively
description: Adherence to the two groups (standard pelvic floor exercises and advanced pelvic floor exercises) will be measured through a logbook that is included in their respective program manuals as well as a logbook completed by the research coordinator during the weekly telephone communications.
measure: Study retention
time frame: 26 weeks post-operative
description: Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
measure: 24-hour Pad Test for Urinary Leakage
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
description: A 24-hour pad test will be used to measure urinary incontinence by assessing the quantity of urine lost in one day. A urinary leakage pad is measured after a 24-hour period and compared to the unused pad weight and is used to most accurately assess the severity of urinary incontinence.
measure: Pelvic Floor Strength
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
description: Digital rectal examination of pelvic floor strength by a specially trained pelvic floor physiotherapist will be conducted. Pelvic floor strength will be graded on the Modified Oxford Scale.
measure: Quality of Life
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative
description: Prostate specific quality of life will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).
measure: 3-Day Bladder Diary for Urinary Incontinence
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
description: The bladder diary is a standard instrument for self-reporting voiding patterns. Items include fluid intake, frequency of toilet voids, episode of urine loss, number of pads used, and activity during event for the three-day period. Bladder diaries are widely used in clinical trials assessing urinary incontinence after radical prostatectomy.
measure: Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
description: Urological symptoms are assessed using the International Prostate Symptom Score (IPSS). Additional, a single item regarding leaking urine and bladder control from the PORPUS will be used to evaluate incontinence. Erectile function will be assessed using the 5-item International Index of Erectile Function scale (5-IIEF).
measure: Body Composition
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
description: Body composition will be assessed via bioelectrical impedance analysis, height, weight, waist and hip circumference, and body mass index.
measure: Physical Activity
time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
description: Physical activity level will be measured wight he 3-item Godin Leisure Time Exercise Questionnaire - Leisure Score Index (GLTEQ-LSI).
arm group label: Usual Care
arm group type: No Intervention
description: The usual care group will receive generic pelvic floor muscle exercise (PMFX) instructions and demonstrations by the research coordinator at the initial post-operative time point. This will include instruction on how to engage the pelvic floor and specific PFMX prescription. Repetition volume will start at 20 repetitions per day during weeks 1-2; 60/day during weeks 3-4; and 90/day during weeks 5-6, and 100+/day for weeks 7-26. The total number of repetitions will be divided equally between rhythmic (contract and relaxed over one second) and sustained contractions (contract and hold for up to 10 seconds).
arm group label: Advanced Pelvic Floor Exercise (APFX)
arm group type: Experimental
description: Participants in this group will receive detailed week-by-week description of the program. The program progresses participants through stages of training every two weeks, starting the introduction of basic PFMX, and slowly incorporates Pfilates and Hypopressives exercises until week 8, where patients will maintain the final stage of training until week 26 or urinary incontinence is completely resolved.
intervention type: Behavioral
intervention name: Advanced Pelvic Floor Muscle Exercise (APFX)
arm group label: Advanced Pelvic Floor Exercise (APFX)
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Daniel Santa Mina
investigator title: Scientist
mesh term: Prostatic Neoplasms