<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/NCT03254355</url>
  </required_header>
  <id_info>
    <org_study_id>MP-31-2018-1758</org_study_id>
    <nct_id>NCT03254355</nct_id>
  </id_info>
  <brief_title>Efficacy of Physiotherapy for Urinary Incontinence in Women With a Puborectalis Avulsion</brief_title>
  <official_title>Efficacy of Physiotherapy for Urinary Incontinence in Women With a Known Avulsion Injury of the Puborectalis Muscle: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Sherbrooke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Sherbrooke</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of&#xD;
      women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the&#xD;
      muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led&#xD;
      to the discovery of this previously unknown major injury and further research now enables its&#xD;
      diagnosis with readily available techniques. Avulsion injury has alarming consequences&#xD;
      because it has been associated with a higher rate of urinary incontinence in the postpartum&#xD;
      period as well as the long-term development of other major urogynecological conditions such&#xD;
      as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from&#xD;
      severe symptoms with significant related impacts on physical activities, overall well-being&#xD;
      and quality of life, but they also present a higher rate of surgical failures. Moreover, it&#xD;
      is still unknown whether the most recommended first-line treatment for urinary incontinence&#xD;
      -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot&#xD;
      study conducted by our team supports the rationale and the efficacy of physiotherapy for&#xD;
      improving PFM function in women with avulsion, despite their major muscle injury.&#xD;
&#xD;
      Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in&#xD;
      women with avulsion at 9-months after randomization compared to a waiting-list control group.&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        1. To compare physiotherapy to the control group after treatment and at 9-months after&#xD;
           randomization in terms of: a) incontinence and prolapse (objective quantification,&#xD;
           symptoms and related impact); b) PFM morphology and function; c) sexual function; d)&#xD;
           self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.&#xD;
&#xD;
        2. To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral)&#xD;
           on the response to physiotherapy treatment on the aforementioned outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter randomized controlled trial using a parallel group design that involves&#xD;
      women with a confirmed diagnosis of avulsion and suffering from urinary incontinence.&#xD;
      Participants will be randomized into either physiotherapy or a waiting-list control group.&#xD;
      Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9&#xD;
      months after randomization. Women in the control group will receive full-body relaxation&#xD;
      massage which has shown no effect on continence but was selected to control for effects of&#xD;
      attention received by the therapist. After the 9-month assessment, women assigned to the&#xD;
      control group will receive the same physiotherapy treatment and undergo a last assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">May 10, 2023</completion_date>
  <primary_completion_date type="Actual">May 10, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent reduction in the number of urinary incontinence episodes</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>The 7-day bladder diary was selected as the primary outcome to measure urinary leakage reduction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in symptoms and impact of incontinence and other urogynecological conditions</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with ICI Modular Questionnaires (ICIQ), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ-SF) and Pelvic Organ Prolapse Symptom score (POP-SS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pelvic floor muscle morphometry and function</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with transperineal ultrasound and dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity of prolapse</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with POP-Q assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sexual function</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-SF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with Broom Pelvic Muscle Self-Efficacy Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost analysis</measure>
    <time_frame>baseline and 9 months after randomization</time_frame>
    <description>Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction and impression of change</measure>
    <time_frame>baseline, post-treatment (3 months post-randomization) and 9 months after randomization</time_frame>
    <description>Evaluated with Patient Satisfaction Questionnaire (PSQ) and Patient's Global Impression of Change (PGIC)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Postpartum</condition>
  <condition>Pelvic Floor; Perineal Rupture, Obstetric</condition>
  <condition>Physiotherapy</condition>
  <arm_group>
    <arm_group_label>Multimodal physiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of weekly multimodal physiotherapy treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting-list control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>12 weeks of weekly full-body relaxation massage</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multimodal physiotherapy</intervention_name>
    <description>12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback</description>
    <arm_group_label>Multimodal physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old&#xD;
&#xD;
          -  Postpartum women (≥ 1 vaginal delivery at term (≥ 37 weeks) and ≥ 3 months postpartum&#xD;
&#xD;
          -  ≥ 3 urinary incontinence episodes per week over the last 3 months (Symptoms of&#xD;
             incontinence must be associated predominantly or solely with stress urinary&#xD;
             incontinence (as opposed to urge incontinence) which will be determined with a&#xD;
             recommended and validated diagnosis questionnaire (Questionnaire for Urinary&#xD;
             Incontinence Diagnosis))&#xD;
&#xD;
          -  Women with diagnosis avulsion injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or postmenopausal&#xD;
&#xD;
          -  Previous pelvic irradiation, urogynecological surgery, or PFM physiotherapy after the&#xD;
             avulsion occurred&#xD;
&#xD;
          -  Significant prolapse (≥3 degree)&#xD;
&#xD;
          -  Incontinence due to other causes such as infection, neurological diseases, voiding&#xD;
             difficulties&#xD;
&#xD;
          -  Any other acute or chronic medical problems likely to interfere with treatment or&#xD;
             evaluation such as cancer, chronic constipation (Rome III criteria), obesity (body&#xD;
             mass index &gt;35), pacemaker, bladder stimulator&#xD;
&#xD;
          -  Medication or ongoing treatment likely to interfere with incontinence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Sherbrooke</investigator_affiliation>
    <investigator_full_name>Mélanie Morin</investigator_full_name>
    <investigator_title>Researcher and Associate Professor</investigator_title>
  </responsible_party>
  <keyword>avulsion injury</keyword>
  <keyword>urinary incontinence</keyword>
  <keyword>multimodal physiotherapy</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>Rupture</mesh_term>
    <mesh_term>Fractures, Avulsion</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/NCT03254355
org study id: MP-31-2018-1758
nct id: NCT03254355
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Childbirth is a major risk factor for pelvic floor muscle (PFM) trauma. In one third of
      women, stretching of the PFM will result in an avulsion injury (i.e. disconnection of the
      muscle from its insertion points on the pubic symphysis). Recent advances in imaging have led
      to the discovery of this previously unknown major injury and further research now enables its
      diagnosis with readily available techniques. Avulsion injury has alarming consequences
      because it has been associated with a higher rate of urinary incontinence in the postpartum
      period as well as the long-term development of other major urogynecological conditions such
      as pelvic organ prolapse and anal incontinence. Women with avulsion not only suffer from
      severe symptoms with significant related impacts on physical activities, overall well-being
      and quality of life, but they also present a higher rate of surgical failures. Moreover, it
      is still unknown whether the most recommended first-line treatment for urinary incontinence
      -PFM physiotherapy- is effective in women with this major trauma. Until now, only a pilot
      study conducted by our team supports the rationale and the efficacy of physiotherapy for
      improving PFM function in women with avulsion, despite their major muscle injury.

      Primary objective: To evaluate the efficacy of physiotherapy for urinary incontinence in
      women with avulsion at 9-months after randomization compared to a waiting-list control group.

      Secondary objectives:

        1. To compare physiotherapy to the control group after treatment and at 9-months after
           randomization in terms of: a) incontinence and prolapse (objective quantification,
           symptoms and related impact); b) PFM morphology and function; c) sexual function; d)
           self-efficacy; e) cost analysis; f) treatment satisfaction and impression of change.

        2. To investigate the impact of the severity of the avulsion (i.e. unilateral or bilateral)
           on the response to physiotherapy treatment on the aforementioned outcomes.
This is a multicenter randomized controlled trial using a parallel group design that involves
      women with a confirmed diagnosis of avulsion and suffering from urinary incontinence.
      Participants will be randomized into either physiotherapy or a waiting-list control group.
      Both groups will be evaluated at baseline, post-treatment (3 months post-randomization) and 9
      months after randomization. Women in the control group will receive full-body relaxation
      massage which has shown no effect on continence but was selected to control for effects of
      attention received by the therapist. After the 9-month assessment, women assigned to the
      control group will receive the same physiotherapy treatment and undergo a last assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent reduction in the number of urinary incontinence episodes
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: The 7-day bladder diary was selected as the primary outcome to measure urinary leakage reduction
measure: Change in symptoms and impact of incontinence and other urogynecological conditions
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with ICI Modular Questionnaires (ICIQ), Pelvic Floor Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire (PFIQ-SF) and Pelvic Organ Prolapse Symptom score (POP-SS)
measure: Change in pelvic floor muscle morphometry and function
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with transperineal ultrasound and dynamometry
measure: Change in severity of prolapse
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with POP-Q assessment
measure: Change in sexual function
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-SF)
measure: Change in self-efficacy
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with Broom Pelvic Muscle Self-Efficacy Scale
measure: Cost analysis
time frame: baseline and 9 months after randomization
description: Evaluated with Dowell-Bryant Incontinence Cost Index (DBICI)
measure: Treatment satisfaction and impression of change
time frame: baseline, post-treatment (3 months post-randomization) and 9 months after randomization
description: Evaluated with Patient Satisfaction Questionnaire (PSQ) and Patient's Global Impression of Change (PGIC)
arm group label: Multimodal physiotherapy
arm group type: Experimental
description: 12 weeks of weekly multimodal physiotherapy treatments
arm group label: Waiting-list control group
arm group type: No Intervention
description: 12 weeks of weekly full-body relaxation massage
intervention type: Procedure
intervention name: Multimodal physiotherapy
description: 12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
arm group label: Multimodal physiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Sherbrooke
investigator full name: Mélanie Morin
investigator title: Researcher and Associate Professor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Rupture
mesh term: Fractures, Avulsion