xml: <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/NCT05970796</url>
    </required_header>
    <id_info>
      <org_study_id>NSTC 112-2314-B-002-315-</org_study_id>
      <nct_id>NCT05970796</nct_id>
    </id_info>
    <brief_title>A Telehealth-delivered Physical Therapy Program for Postmenopausal Women With Urinary Incontinence</brief_title>
    <official_title>The Feasibility and Effects of a Telehealth-delivered Physical Therapy Program for Postmenopausal Women With Urinary Incontinence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University</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>
        Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal&#xD;
        dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic&#xD;
        symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety,&#xD;
        cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the&#xD;
        most common manifestations of pelvic floor dysfunction and may significantly impact on&#xD;
        women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal&#xD;
        women and is primarily attributed to the decreased level of estrogen. Other potential risk&#xD;
        factors for urinary incontinence after menopause include age, parity, genetic factors,&#xD;
        pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract&#xD;
        infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic&#xD;
        floor muscle training and bladder training as first-line treatments for urinary incontinence&#xD;
        in postmenopausal women. During the COVID-19 pandemic, access to and utilization of&#xD;
        healthcare services is reduced. As travel distance has been reported as one of the strong&#xD;
        barriers to healthcare among patients with incontinence, research has been conducted to&#xD;
        investigate the applications and effects of telehealth. While telehealth rehabilitation may&#xD;
        improve urinary incontinence symptoms, the field is still emerging and more studies are&#xD;
        needed to elucidate how physical therapists can perform telehealth pelvic floor muscle&#xD;
        training for urinary incontinence.&#xD;
  &#xD;
        The objectives of this three-year study are:&#xD;
  &#xD;
          1. to investigate the feasibility of a telehealth-delivered physical therapy program for&#xD;
             postmenopausal women with urinary incontinence&#xD;
  &#xD;
          2. to explore the effects of a telehealth-delivered physical therapy program on urinary&#xD;
             incontinence symptoms, pelvic floor muscle function and quality of life in&#xD;
             postmenopausal women with urinary incontinence&#xD;
  &#xD;
          3. to compare the effectiveness of telehealth physical therapy program with face-to-face&#xD;
             physical therapy in this population&#xD;
  &#xD;
          4. to compare body composition, physical activity levels, functional capacity, grip&#xD;
             strength, urinary incontinence symptoms, and pelvic floor muscles function in women at&#xD;
             early versus late stage of post-menopause&#xD;
  &#xD;
          5. to evaluate the relationships between duration after menopause and body composition,&#xD;
             physical activity levels, functional capacity, grip strength, urinary incontinence&#xD;
             symptoms, and pelvic floor muscles function&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a non-inferiority randomized controlled trial with a nested cross-sectional study and&#xD;
        a nested qualitative interview study. Sixty community-dwelling postmenopausal women with&#xD;
        urinary incontinence, aged &gt;40 years, will be recruited and randomly allocated to two groups,&#xD;
        telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle&#xD;
        training. The face-to-face group will be supervised by a female physical therapist who will&#xD;
        provide pelvic floor muscle training twice a week. The training will be adjusted according to&#xD;
        the performance of the participant. The telehealth group will receive eight sessions of&#xD;
        individualized pelvic floor muscle training provided by a physical therapist via telehealth&#xD;
        in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month&#xD;
        follow-up assessments will include feasibility outcomes, measurements of anthropometry, body&#xD;
        composition (body composition monitor), hand grip strength (dynamometer), functional exercise&#xD;
        capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry,&#xD;
        transperineal ultrasound and digital palpation) and two questionnaires about symptom severity&#xD;
        of urinary incontinence and physical activity levels. This study will provide evidence of&#xD;
        effectiveness of different delivery modes of physical therapy program for postmenopausal&#xD;
        women with urinary incontinence and health-care professionals working with this population in&#xD;
        clinical practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants consented to participate</measure>
      <time_frame>absolute values at baseline</time_frame>
      <description>Consent rate: number of participants enrolled will be divided by number of eligible patients approached</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of intervention sessions attended</measure>
      <time_frame>absolute values at 12 weeks</time_frame>
      <description>Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who remain in the study 3 months after baseline assessment</measure>
      <time_frame>absolute values at 3 months</time_frame>
      <description>Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants who withdrew from the trial</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of completed training sessions in relation to the scheduled sessions</measure>
      <time_frame>absolute values at 12 weeks</time_frame>
      <description>Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with intervention-related adverse events as assessed by CTCAE v4.0</measure>
      <time_frame>absolute values at 12 weeks</time_frame>
      <description>Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction scale</measure>
      <time_frame>absolute values at 12 weeks</time_frame>
      <description>Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability scale</measure>
      <time_frame>absolute values at 12 weeks</time_frame>
      <description>Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Weight in kilograms will be measured using a Full Body Sensor Body Composition Monitor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Height in meters will be measured using a measuring tape.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Weight and height will be combined to report body mass index in kg/m^2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body fat percentage</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Body fat percentage will be measured using a Full Body Sensor Body Composition Monitor. Body fat percentage will be classified as 5.0 to 19.9% (low), 20.0 to 29.9% (normal), 30.0 to 34.9% (high), and 35.0% and above (very high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visceral fat level</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Visceral fat level will be measured using a Full Body Sensor Body Composition Monitor. Visceral fat level will be classified as 1 to 9 (normal), 10 to 14 (high), and 15 to 30 (very high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skeletal muscle percentage</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Skeletal muscle percentage will be measured using a Full Body Sensor Body Composition Monitor. Skeletal muscle percentage will be classified as 5.0 to 25.8% (low), 25.9 to 37.9% (normal), 28.0 to 29.0% (high), and 29.1 to 60.0% (very high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Handgrip strength</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>The grip strength of dominant hand will be measured in kilograms using a Jamar Plus+ Dynamometer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional exercise capacity</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Functional exercise capacity will be assessed using six-minute walk test. The distance covered over a time of 6 minutes will be recorded in meters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic floor muscle strength</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Pelvic floor muscle strength will be measured using digital palpation. The results will be recorded using the modified Oxford Grading scale, which quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bladder neck descent</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Bladder neck descent will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anteroposterior diameter of the urogenital levator hiatus</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Anteroposterior diameter of the urogenital levator hiatus will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anorectal angle</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>Anorectal angle will be measured using a transperineal ultrasound. The anorectal angle between the anal canal longitudinal axis and the posterior rectal line will be measured in degrees at rest and during maximal voluntary contraction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity of urinary incontinence</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>The severity of urinary incontinence will be measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The total score ranges from 0-21 with a higher score indicating greater severity of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity levels</measure>
      <time_frame>absolute values at 12 weeks and 3 months</time_frame>
      <description>The International Physical Activity Questionnaire - Short Form will be used to measure total physical activity levels in MET minutes a week with a higher score corresponding to a higher physical activity level.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>Telehealth group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face-to-face group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pelvic floor muscle training</intervention_name>
      <description>The pelvic floor muscle training program will be provided via an intra-vaginal biofeedback device - Smart Kegel Trainer, which will be connected to the product application installed on the mobile phone or tablet so the participants can monitor their pelvic floor contractions in real time and directly in the application. Participants will be asked to complete three sets of 8 to 12 maximal pelvic floor muscle contractions and three to ten fast contractions per training session. The home program will be tailored to each participant and include &quot;pelvic floor safe&quot; exercises recommended by the Continence Foundation of Australia.</description>
      <arm_group_label>Face-to-face group</arm_group_label>
      <arm_group_label>Telehealth group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. women aged over 40 years&#xD;
  &#xD;
            2. postmenopausal women: amenorrhea for longer than 12 months&#xD;
  &#xD;
            3. having symptomatic UI (defined as having the Questionnaire for Urinary Incontinence&#xD;
               Diagnosis score &gt; 0 point)&#xD;
  &#xD;
            4. being able to answer the questionnaire correctly (no language barrier or cognitive&#xD;
               problems)&#xD;
  &#xD;
            5. having no other physical or psychological problem that would interfere participation&#xD;
               in the study&#xD;
  &#xD;
            6. having access to a mobile video conference device with internet access&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. women aged over 85 years old&#xD;
  &#xD;
            2. receiving hormone therapy&#xD;
  &#xD;
            3. having neurological conditions, malignancy for pelvic organ, overflow incontinence or&#xD;
               voiding dysfunction&#xD;
  &#xD;
            4. had received radical surgery for pelvis, sling or prolapse surgery&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kuan-Yin Lin, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kuan-Yin Lin, Ph.D.</last_name>
      <phone>0965581178</phone>
      <email>idoruyin0808@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan University</investigator_affiliation>
      <investigator_full_name>Kuan-Yin Lin</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970796
  org study id: NSTC 112-2314-B-002-315-
  nct id: NCT05970796
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Postmenopausal women frequently report physical (hot flushes, night sweat, insomnia, vaginal
        dryness, sexual dysfunction, urinary incontinence, reduced fitness level, osteoporotic
        symptoms, sarcopenia, decreased fat free mass, etc.) and psychological (depression, anxiety,
        cognitive decline, etc.) symptoms. Among these symptoms, urinary incontinence is one of the
        most common manifestations of pelvic floor dysfunction and may significantly impact on
        women's quality of life. Urinary incontinence is highly prevalent (30%) in postmenopausal
        women and is primarily attributed to the decreased level of estrogen. Other potential risk
        factors for urinary incontinence after menopause include age, parity, genetic factors,
        pregnancy, overweight/obesity, low physical activity levels, diabetes, urinary tract
        infection, etc. International guidelines recommend lifestyle and behavioral change, pelvic
        floor muscle training and bladder training as first-line treatments for urinary incontinence
        in postmenopausal women. During the COVID-19 pandemic, access to and utilization of
        healthcare services is reduced. As travel distance has been reported as one of the strong
        barriers to healthcare among patients with incontinence, research has been conducted to
        investigate the applications and effects of telehealth. While telehealth rehabilitation may
        improve urinary incontinence symptoms, the field is still emerging and more studies are
        needed to elucidate how physical therapists can perform telehealth pelvic floor muscle
        training for urinary incontinence.
  
        The objectives of this three-year study are:
  
          1. to investigate the feasibility of a telehealth-delivered physical therapy program for
             postmenopausal women with urinary incontinence
  
          2. to explore the effects of a telehealth-delivered physical therapy program on urinary
             incontinence symptoms, pelvic floor muscle function and quality of life in
             postmenopausal women with urinary incontinence
  
          3. to compare the effectiveness of telehealth physical therapy program with face-to-face
             physical therapy in this population
  
          4. to compare body composition, physical activity levels, functional capacity, grip
             strength, urinary incontinence symptoms, and pelvic floor muscles function in women at
             early versus late stage of post-menopause
  
          5. to evaluate the relationships between duration after menopause and body composition,
             physical activity levels, functional capacity, grip strength, urinary incontinence
             symptoms, and pelvic floor muscles function
  This is a non-inferiority randomized controlled trial with a nested cross-sectional study and
        a nested qualitative interview study. Sixty community-dwelling postmenopausal women with
        urinary incontinence, aged >40 years, will be recruited and randomly allocated to two groups,
        telehealth group or face-to-face group. All groups will receive a 12-week pelvic floor muscle
        training. The face-to-face group will be supervised by a female physical therapist who will
        provide pelvic floor muscle training twice a week. The training will be adjusted according to
        the performance of the participant. The telehealth group will receive eight sessions of
        individualized pelvic floor muscle training provided by a physical therapist via telehealth
        in addition to a weekly telephone coaching. The baseline, post-intervention, and 3-month
        follow-up assessments will include feasibility outcomes, measurements of anthropometry, body
        composition (body composition monitor), hand grip strength (dynamometer), functional exercise
        capacity (six minute walk test), and pelvic floor muscle function (vaginal manometry,
        transperineal ultrasound and digital palpation) and two questionnaires about symptom severity
        of urinary incontinence and physical activity levels. This study will provide evidence of
        effectiveness of different delivery modes of physical therapy program for postmenopausal
        women with urinary incontinence and health-care professionals working with this population in
        clinical practice.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Number of participants consented to participate
  time frame: absolute values at baseline
  description: Consent rate: number of participants enrolled will be divided by number of eligible patients approached
  measure: Number of intervention sessions attended
  time frame: absolute values at 12 weeks
  description: Attendance rate: number of sessions attended will be divided by the total number of expected sessions within each treatment arm
  measure: Number of participants who remain in the study 3 months after baseline assessment
  time frame: absolute values at 3 months
  description: Retention rate: number of participants who remain in the study at 3-month follow-up as a proportion of the total number of participants recruited at the baseline assessment
  measure: Number of participants who withdrew from the trial
  time frame: absolute values at 12 weeks and 3 months
  description: Withdrawal rate: number of participants who withdraw from the trial after consenting divided by the number of participants who initially consent to the trial
  measure: Number of completed training sessions in relation to the scheduled sessions
  time frame: absolute values at 12 weeks
  description: Adherence rate: the total number of exercise sessions completed as a proportion of that prescribed each week from baseline to 12 week.
  measure: Number of participants with intervention-related adverse events as assessed by CTCAE v4.0
  time frame: absolute values at 12 weeks
  description: Adverse events: the number of adverse or serious adverse events throughout the 12-week intervention period. Participants will be asked about any symptoms (such as pain, bleeding or itching) at each training session.
  measure: Satisfaction scale
  time frame: absolute values at 12 weeks
  description: Satisfaction will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
  measure: Acceptability scale
  time frame: absolute values at 12 weeks
  description: Acceptability will be was assessed using a five-point Likert-scale ranging from '1 = very dissatisfied' to '5 = very satisfied'.
  measure: Weight
  time frame: absolute values at 12 weeks and 3 months
  description: Weight in kilograms will be measured using a Full Body Sensor Body Composition Monitor.
  measure: Height
  time frame: absolute values at 12 weeks and 3 months
  description: Height in meters will be measured using a measuring tape.
  measure: Body mass index
  time frame: absolute values at 12 weeks and 3 months
  description: Weight and height will be combined to report body mass index in kg/m^2
  measure: Body fat percentage
  time frame: absolute values at 12 weeks and 3 months
  description: Body fat percentage will be measured using a Full Body Sensor Body Composition Monitor. Body fat percentage will be classified as 5.0 to 19.9% (low), 20.0 to 29.9% (normal), 30.0 to 34.9% (high), and 35.0% and above (very high).
  measure: Visceral fat level
  time frame: absolute values at 12 weeks and 3 months
  description: Visceral fat level will be measured using a Full Body Sensor Body Composition Monitor. Visceral fat level will be classified as 1 to 9 (normal), 10 to 14 (high), and 15 to 30 (very high).
  measure: Skeletal muscle percentage
  time frame: absolute values at 12 weeks and 3 months
  description: Skeletal muscle percentage will be measured using a Full Body Sensor Body Composition Monitor. Skeletal muscle percentage will be classified as 5.0 to 25.8% (low), 25.9 to 37.9% (normal), 28.0 to 29.0% (high), and 29.1 to 60.0% (very high).
  measure: Handgrip strength
  time frame: absolute values at 12 weeks and 3 months
  description: The grip strength of dominant hand will be measured in kilograms using a Jamar Plus+ Dynamometer.
  measure: Functional exercise capacity
  time frame: absolute values at 12 weeks and 3 months
  description: Functional exercise capacity will be assessed using six-minute walk test. The distance covered over a time of 6 minutes will be recorded in meters.
  measure: Pelvic floor muscle strength
  time frame: absolute values at 12 weeks and 3 months
  description: Pelvic floor muscle strength will be measured using digital palpation. The results will be recorded using the modified Oxford Grading scale, which quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
  measure: Bladder neck descent
  time frame: absolute values at 12 weeks and 3 months
  description: Bladder neck descent will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.
  measure: Anteroposterior diameter of the urogenital levator hiatus
  time frame: absolute values at 12 weeks and 3 months
  description: Anteroposterior diameter of the urogenital levator hiatus will be measured in centimeters using a transperineal ultrasound at rest and during maximal voluntary contraction.
  measure: Anorectal angle
  time frame: absolute values at 12 weeks and 3 months
  description: Anorectal angle will be measured using a transperineal ultrasound. The anorectal angle between the anal canal longitudinal axis and the posterior rectal line will be measured in degrees at rest and during maximal voluntary contraction.
  measure: Severity of urinary incontinence
  time frame: absolute values at 12 weeks and 3 months
  description: The severity of urinary incontinence will be measured using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. The total score ranges from 0-21 with a higher score indicating greater severity of symptoms.
  measure: Physical activity levels
  time frame: absolute values at 12 weeks and 3 months
  description: The International Physical Activity Questionnaire - Short Form will be used to measure total physical activity levels in MET minutes a week with a higher score corresponding to a higher physical activity level.
  arm group label: Telehealth group
  arm group type: Experimental
  description: The telehealth group will receive eight sessions of individualized pelvic floor muscle training provided by a physical therapist via telehealth in 12 weeks.
  arm group label: Face-to-face group
  arm group type: Active Comparator
  description: The face-to-face group will be supervised by a female physical therapist who will provide pelvic floor muscle training twice a week for 12 weeks.
  intervention type: Behavioral
  intervention name: Pelvic floor muscle training
  description: The pelvic floor muscle training program will be provided via an intra-vaginal biofeedback device - Smart Kegel Trainer, which will be connected to the product application installed on the mobile phone or tablet so the participants can monitor their pelvic floor contractions in real time and directly in the application. Participants will be asked to complete three sets of 8 to 12 maximal pelvic floor muscle contractions and three to ten fast contractions per training session. The home program will be tailored to each participant and include "pelvic floor safe" exercises recommended by the Continence Foundation of Australia.
  arm group label: Face-to-face group
  arm group label: Telehealth group
  criteria: 
  gender: Female
  minimum age: 40 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Kuan-Yin Lin, Ph.D.
  role: Principal Investigator
  affiliation: National Taiwan University
  last name: Kuan-Yin Lin, Ph.D.
  phone: 0965581178
  email: idoruyin0808@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University
  investigator full name: Kuan-Yin Lin
  investigator title: Assistant Professor
  mesh term: Urinary Incontinence
  mesh term: Enuresis