<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/NCT04484753</url>
  </required_header>
  <id_info>
    <org_study_id>Faculdade Inspirar</org_study_id>
    <nct_id>NCT04484753</nct_id>
  </id_info>
  <brief_title>Validation of iPelvis App for Female Pelvic Floor Dysfunction</brief_title>
  <official_title>Validation of the iPelvis Mobile Application for Pelvic Physiotherapy in Women With Female Pelvic Floor Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rogério de Fraga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculdade Inspirar</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor&#xD;
      related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary dysfunctions are widely discussed because they cause problems in social, emotional,&#xD;
      sexual life and the quality of life of incontinent women. The overall objective of this&#xD;
      research is to evaluate the use of the Application. Ipelvis in women with urinary&#xD;
      incontinence. This is a longitudinal study of the type randomized controlled trial. Women&#xD;
      with urinary incontinence of urgency, effort and effort will be evaluated and treated.&#xD;
      Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health&#xD;
      Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic&#xD;
      floor musculature function. As volunteers are drawn in four groups (Group I: Household&#xD;
      Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic&#xD;
      Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)</measure>
    <time_frame>3 Months</time_frame>
    <description>A tool that assesses the impact of UI on the quality of life and severity of urinary symptoms. The questionnaire is composed of four questions related to frequency, severity of urinary loss and its impact on quality of life. The ICIQ score is the sum of the scores from questions three, four and five and ranges from 0 to 21.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kings Health Questionnaire (KHQ)</measure>
    <time_frame>3 Months</time_frame>
    <description>A questionnaire that analyzes the presence of Urinary Incontinence symptoms and their impact on various aspects of individuality in quality of life. The questionnaire is composed of 30 questions subdivided into nine domains. They report, respectively, the general perception of health, the impact of incontinence, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, and severity measures. To achieve the overall KHQ score, some pre-established calculations were performed, which provided scores for subsequent correlations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Female Sexual Function Index (FSFI)</measure>
    <time_frame>3 Months</time_frame>
    <description>The questionnaire consists of 19 questions, which provide information on five domains of sexual response: desire and subjective stimulation, lubrication, orgasm, satisfaction and pain or discomfort. Individual scores are considered by the sum of items that comprise each domain (simple score), which are multiplied by the factor of that domain and can be explored or weighted. A final score (total scores: minimum of 2 and maximum of 36) is the total value of weighted scores for each domain.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Female Sexual Dysfunction</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Home Exercise Sheet</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant took the sheet with the description of the exercises to his address.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ipelvis mobile application</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The participant received the app and performs home exercises guided by the app.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home exercise sheet + Pelvic Physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant did group physical therapy and used the exercise sheet at home on other days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ipelvis mobile application + Pelvic Physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant did group physical therapy and used the mobile application on other days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Exercise Sheet</intervention_name>
    <description>Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.</description>
    <arm_group_label>Home Exercise Sheet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ipelvis mobile application</intervention_name>
    <description>Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.</description>
    <arm_group_label>Ipelvis mobile application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home exercise sheet + Pelvic Physiotherapy</intervention_name>
    <description>Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.</description>
    <arm_group_label>Home exercise sheet + Pelvic Physiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Ipelvis mobile application + Pelvic Physiotherapy</intervention_name>
    <description>Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.</description>
    <arm_group_label>Ipelvis mobile application + Pelvic Physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with urinary incontinence by urodynamics, stress and mixed urinary incontinence,&#xD;
             aged between 18 and 59 years, who have cognitive ability, have a compatible cell to&#xD;
             install the Ipelvis application and who sign the Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, women up to six months postpartum, women with prolapse greater than&#xD;
             stage III by Pelvic Organ Prolapse - Quantification (POP-Q), women with urinary tract&#xD;
             infection, women with pelvic pain Performing therapies offered or having undergone&#xD;
             pelvic surgery within a period of less than six months; With a pacemaker or&#xD;
             contraceptive device (IUD); Women with intrapelvic tumor.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rogério Fraga</last_name>
    <role>Study Director</role>
    <affiliation>Faculdade Inspirar</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Faculdade Inspirar</investigator_affiliation>
    <investigator_full_name>Rogério de Fraga</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <keyword>urinary incontinence</keyword>
  <keyword>female sexual dysfunction</keyword>
  <keyword>quality of life</keyword>
  <keyword>adherence</keyword>
  <keyword>pelvic physiotherapy</keyword>
  <keyword>post-partum</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04484753
org study id: Faculdade Inspirar
nct id: NCT04484753
lead sponsor: 
has dmc: Yes
is fda regulated device: No
The iPelvis app aims to improve adherence to pelvic physiotherapy on women with pelvic floor
      related dysfunctions, such as urinary or fecal incontinence, sexual dysfunction, etc.
Urinary dysfunctions are widely discussed because they cause problems in social, emotional,
      sexual life and the quality of life of incontinent women. The overall objective of this
      research is to evaluate the use of the Application. Ipelvis in women with urinary
      incontinence. This is a longitudinal study of the type randomized controlled trial. Women
      with urinary incontinence of urgency, effort and effort will be evaluated and treated.
      Frequently asked questions, questions and answers, Quality of Life Questionnaires, Health
      Requirements, ICIQ-SF, ICIQ-OAB, FSFI and evaluation of pelvic, manual and electromyographic
      floor musculature function. As volunteers are drawn in four groups (Group I: Household
      Exercise Sheet / Group II: Ipelvis application / Group III: Household Exercise Sheet + Pelvic
      Physiotherapy / Group IV Ipelvis Application + Pelvic Physiotherapy).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
time frame: 3 Months
description: A tool that assesses the impact of UI on the quality of life and severity of urinary symptoms. The questionnaire is composed of four questions related to frequency, severity of urinary loss and its impact on quality of life. The ICIQ score is the sum of the scores from questions three, four and five and ranges from 0 to 21.
measure: Kings Health Questionnaire (KHQ)
time frame: 3 Months
description: A questionnaire that analyzes the presence of Urinary Incontinence symptoms and their impact on various aspects of individuality in quality of life. The questionnaire is composed of 30 questions subdivided into nine domains. They report, respectively, the general perception of health, the impact of incontinence, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, and severity measures. To achieve the overall KHQ score, some pre-established calculations were performed, which provided scores for subsequent correlations.
measure: The Female Sexual Function Index (FSFI)
time frame: 3 Months
description: The questionnaire consists of 19 questions, which provide information on five domains of sexual response: desire and subjective stimulation, lubrication, orgasm, satisfaction and pain or discomfort. Individual scores are considered by the sum of items that comprise each domain (simple score), which are multiplied by the factor of that domain and can be explored or weighted. A final score (total scores: minimum of 2 and maximum of 36) is the total value of weighted scores for each domain.
arm group label: Home Exercise Sheet
arm group type: Other
description: The participant took the sheet with the description of the exercises to his address.
arm group label: Ipelvis mobile application
arm group type: Other
description: The participant received the app and performs home exercises guided by the app.
arm group label: Home exercise sheet + Pelvic Physiotherapy
arm group type: Active Comparator
description: The participant did group physical therapy and used the exercise sheet at home on other days.
arm group label: Ipelvis mobile application + Pelvic Physiotherapy
arm group type: Active Comparator
description: The participant did group physical therapy and used the mobile application on other days.
intervention type: Other
intervention name: Home Exercise Sheet
description: Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
arm group label: Home Exercise Sheet
intervention type: Other
intervention name: Ipelvis mobile application
description: Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
arm group label: Ipelvis mobile application
intervention type: Behavioral
intervention name: Home exercise sheet + Pelvic Physiotherapy
description: Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
arm group label: Home exercise sheet + Pelvic Physiotherapy
intervention type: Behavioral
intervention name: Ipelvis mobile application + Pelvic Physiotherapy
description: Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
arm group label: Ipelvis mobile application + Pelvic Physiotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Rogério Fraga
role: Study Director
affiliation: Faculdade Inspirar
responsible party type: Sponsor-Investigator
investigator affiliation: Faculdade Inspirar
investigator full name: Rogério de Fraga
investigator title: director
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No