<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/NCT03272386</url>
  </required_header>
  <id_info>
    <org_study_id>P. GREEN 01</org_study_id>
    <nct_id>NCT03272386</nct_id>
  </id_info>
  <brief_title>Best Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction</brief_title>
  <official_title>Verbal Instruction to Obtain Voluntary Pelvic Floor Muscle Contraction: Acceptability, Understanding and Best Instruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre and Marie Curie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre and Marie Curie 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>
      The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to&#xD;
      evaluate the understanding and acceptability of the proposed instructions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic floor muscles contraction (PFMC) is usually recommended for evaluation and treatment&#xD;
      of pelvic floor disorders.&#xD;
&#xD;
      In clinical practice, many patients fail to achieve a voluntary PFMC and only about one-third&#xD;
      of women perform an ideal PFMC after brief written or verbal instruction. When no PFMC is&#xD;
      elicited, it might be explained by an anatomical or neurological issue but also by a lack of&#xD;
      understanding of the instructions and / or poor knowledge of the anatomy. Pelvic floor&#xD;
      muscles (PFM) evaluation may depends on the method used to elicit and assess the contraction&#xD;
      including verbal instructions. There is no current gold standard methodology for quantifying&#xD;
      PFM strength and the verbal instructions used to elicit the PFMC are rarely reported in the&#xD;
      studies. There is few specific works about the instructions. One recent study report that the&#xD;
      pattern of urethral movement is influenced by the instructions used to teach activation of&#xD;
      the PFM in men. Another study showed that some specific instructions are most effective in&#xD;
      eliciting a correct PFMC in women.&#xD;
&#xD;
      Thus, an appropriate verbal instruction in terms of understanding, social and cultural&#xD;
      acceptability, taking into account the anatomical knowledge of the patients, would probably&#xD;
      allow a better evaluation of the PFM and even a better efficacy of pelvic floor training.&#xD;
&#xD;
      The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to&#xD;
      evaluate the understanding and acceptability of the proposed instructions.&#xD;
&#xD;
      This is a prospective observational study lead in two phases in the Neurourology Department&#xD;
      of a University Hospital.&#xD;
&#xD;
      Phase 1: survey carry out the health professionals. Members of the scientific committees of&#xD;
      national academic societies in neuro-urology, pelvi-perineology and pelvic-floor&#xD;
      neurophysiology would be invited to answer a questionnaire by mail. It will include open&#xD;
      questions about the most frequently verbal instructions used to elicit a PFMC. These&#xD;
      instructions will be collected, analysed and selected for the second phase.&#xD;
&#xD;
      Phase 2: structured interviews with patients and with non-health professional subjects.&#xD;
&#xD;
      Patients and non-health professionals subjects will be invited to answer a 3-parts&#xD;
      questionnaire based on the gender: (i) demographic, social and medical data; (ii) evaluation&#xD;
      of the anatomical knowledge of the perineum with a picture of the perineum and a sagittal&#xD;
      section of the pelvic area of the corresponding sex. In the third part (iii), the&#xD;
      participants will assess the instructions selected in the first phase according to their&#xD;
      understanding and their acceptability (good, intermediate, poor). They finally will have to&#xD;
      choose the best instruction i.e. which seems to be the more suitable to obtain a PFMC.&#xD;
&#xD;
      Ethics: a local ethics committee approved this study. Since it is an observational study, the&#xD;
      participant will have a newsletter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">September 29, 2017</completion_date>
  <primary_completion_date type="Actual">September 18, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of the instructions used by the professionals</measure>
    <time_frame>1 day during the consultation</time_frame>
    <description>Qualitative description of the instructions and selection of the most frequent instructions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability, understanding and selection of the best instruction by the subjects</measure>
    <time_frame>1 day during the consultation</time_frame>
    <description>Description of the selected instructions by the subjects : their acceptability (poor / moderate / good), and understanding (poor / moderate / good) and the best instruction to obtain PFMC (among the selected instructions).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">33</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Observational study</arm_group_label>
    <description>Observational study with patients over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <description>Completing a questionnaire</description>
    <arm_group_label>Observational study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients consulting in a tertiary center in neuro-urology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Follow in neuro-urology&#xD;
&#xD;
          -  Lower urinary tract symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Can't speak French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gérard Amarenco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of neuro-urology, hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Gérard Amarenco</investigator_full_name>
    <investigator_title>Head of Neuro-Urology department, Tenon hospital</investigator_title>
  </responsible_party>
  <keyword>pelvic floor muscles</keyword>
  <keyword>instruction</keyword>
  <keyword>assessment</keyword>
  <keyword>acceptability</keyword>
  <keyword>understanding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT03272386
org study id: P. GREEN 01
nct id: NCT03272386
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to
      evaluate the understanding and acceptability of the proposed instructions.
Pelvic floor muscles contraction (PFMC) is usually recommended for evaluation and treatment
      of pelvic floor disorders.

      In clinical practice, many patients fail to achieve a voluntary PFMC and only about one-third
      of women perform an ideal PFMC after brief written or verbal instruction. When no PFMC is
      elicited, it might be explained by an anatomical or neurological issue but also by a lack of
      understanding of the instructions and / or poor knowledge of the anatomy. Pelvic floor
      muscles (PFM) evaluation may depends on the method used to elicit and assess the contraction
      including verbal instructions. There is no current gold standard methodology for quantifying
      PFM strength and the verbal instructions used to elicit the PFMC are rarely reported in the
      studies. There is few specific works about the instructions. One recent study report that the
      pattern of urethral movement is influenced by the instructions used to teach activation of
      the PFM in men. Another study showed that some specific instructions are most effective in
      eliciting a correct PFMC in women.

      Thus, an appropriate verbal instruction in terms of understanding, social and cultural
      acceptability, taking into account the anatomical knowledge of the patients, would probably
      allow a better evaluation of the PFM and even a better efficacy of pelvic floor training.

      The purpose of this study is to determine the best verbal instruction to obtain a PFMC and to
      evaluate the understanding and acceptability of the proposed instructions.

      This is a prospective observational study lead in two phases in the Neurourology Department
      of a University Hospital.

      Phase 1: survey carry out the health professionals. Members of the scientific committees of
      national academic societies in neuro-urology, pelvi-perineology and pelvic-floor
      neurophysiology would be invited to answer a questionnaire by mail. It will include open
      questions about the most frequently verbal instructions used to elicit a PFMC. These
      instructions will be collected, analysed and selected for the second phase.

      Phase 2: structured interviews with patients and with non-health professional subjects.

      Patients and non-health professionals subjects will be invited to answer a 3-parts
      questionnaire based on the gender: (i) demographic, social and medical data; (ii) evaluation
      of the anatomical knowledge of the perineum with a picture of the perineum and a sagittal
      section of the pelvic area of the corresponding sex. In the third part (iii), the
      participants will assess the instructions selected in the first phase according to their
      understanding and their acceptability (good, intermediate, poor). They finally will have to
      choose the best instruction i.e. which seems to be the more suitable to obtain a PFMC.

      Ethics: a local ethics committee approved this study. Since it is an observational study, the
      participant will have a newsletter.
observational model: Other
time perspective: Prospective
measure: Description of the instructions used by the professionals
time frame: 1 day during the consultation
description: Qualitative description of the instructions and selection of the most frequent instructions.
measure: Acceptability, understanding and selection of the best instruction by the subjects
time frame: 1 day during the consultation
description: Description of the selected instructions by the subjects : their acceptability (poor / moderate / good), and understanding (poor / moderate / good) and the best instruction to obtain PFMC (among the selected instructions).
arm group label: Observational study
description: Observational study with patients over 18 years old, consulting for lower urinary tract symptoms in a tertiary center are included.
intervention type: Other
intervention name: Observational study
description: Completing a questionnaire
arm group label: Observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gérard Amarenco, PhD
role: Principal Investigator
affiliation: UPMC, Sorbonne Université, Univ Paris 6, service neuro-urologie, hôpital TENON, Paris
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Gérard Amarenco
investigator title: Head of Neuro-Urology department, Tenon hospital
mesh term: Lower Urinary Tract Symptoms