<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/NCT02212418</url>
  </required_header>
  <id_info>
    <org_study_id>UValladolid_1</org_study_id>
    <nct_id>NCT02212418</nct_id>
  </id_info>
  <brief_title>Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women</brief_title>
  <acronym>UVa_1</acronym>
  <official_title>Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rafael J. Curbelo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valladolid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic&#xD;
      floor dysfunctions in the postpartum. In the last years it has been extended out of such&#xD;
      medical context but there is a lack of scientific evidence, and the endurability of the&#xD;
      effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a&#xD;
      12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary&#xD;
      incontinence, in women out of the postpartum phase. In addition the investigators looked for&#xD;
      the endurability of its effect.&#xD;
&#xD;
      Methods: The investigators performed a cross-over blinded intervention study of 4 month&#xD;
      duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no&#xD;
      AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2&#xD;
      months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2&#xD;
      months versus AHT.&#xD;
&#xD;
      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,&#xD;
      as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired&#xD;
      as adequate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of pelvic floor tone at 2 months and after 4 months</measure>
    <time_frame>at baseline, after 2 months, and after 4 months</time_frame>
    <description>Pelvic floor tone was measured by a tonometer (PhoenixTM USB2, France) in a PelvimètreTM, and results are expressed in g/cm2. A physiotherapist specialist in urogynecology did the measurement. This measure was not available for women in their first three days of menstruation or virgins</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of urinary incontinence at 2 months and after 4 months</measure>
    <time_frame>perfomed at baseline, after 2 months, and after 4 months</time_frame>
    <description>Urinary incontinence was measured with the International Consultation on Incontinence Questionnaire - Short Form (ICIQ_SF) . The questionnaire includes three scored items about frequency, severity and perceived impact of incontinence.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Mild Pelvic Floor Dysfunction</condition>
  <arm_group>
    <arm_group_label>Abdominal hypopressive technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Abdominal hypopressive technique</intervention_name>
    <description>postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible</description>
    <arm_group_label>Abdominal hypopressive technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤&#xD;
             2 weeks per month)&#xD;
&#xD;
          -  between 20 and 65 years old&#xD;
&#xD;
          -  with availability for three afternoons per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  serious diseases&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  postpartum phase up to 2 months after delivery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lidon Soriano, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alfonso X El Sabio University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafael J Curbelo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valladolid</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Loreto Carmona, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Instituto de Salud Músculo Esquelética</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Valladolid</investigator_affiliation>
    <investigator_full_name>Rafael J. Curbelo</investigator_full_name>
    <investigator_title>PhD</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>


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/NCT02212418
org study id: UValladolid_1
nct id: NCT02212418
lead sponsor: 
has dmc: No
Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic
      floor dysfunctions in the postpartum. In the last years it has been extended out of such
      medical context but there is a lack of scientific evidence, and the endurability of the
      effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a
      12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary
      incontinence, in women out of the postpartum phase. In addition the investigators looked for
      the endurability of its effect.

      Methods: The investigators performed a cross-over blinded intervention study of 4 month
      duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no
      AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2
      months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2
      months versus AHT.

      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,
      as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired
      as adequate.
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: change of pelvic floor tone at 2 months and after 4 months
time frame: at baseline, after 2 months, and after 4 months
description: Pelvic floor tone was measured by a tonometer (PhoenixTM USB2, France) in a PelvimètreTM, and results are expressed in g/cm2. A physiotherapist specialist in urogynecology did the measurement. This measure was not available for women in their first three days of menstruation or virgins
measure: change of urinary incontinence at 2 months and after 4 months
time frame: perfomed at baseline, after 2 months, and after 4 months
description: Urinary incontinence was measured with the International Consultation on Incontinence Questionnaire - Short Form (ICIQ_SF) . The questionnaire includes three scored items about frequency, severity and perceived impact of incontinence.
arm group label: Abdominal hypopressive technique
arm group type: Experimental
intervention type: Other
intervention name: Abdominal hypopressive technique
description: postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible
arm group label: Abdominal hypopressive technique
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lidon Soriano, PhD
role: Principal Investigator
affiliation: Alfonso X El Sabio University
last name: Rafael J Curbelo, PhD
role: Principal Investigator
affiliation: University of Valladolid
last name: Loreto Carmona, PhD
role: Study Director
affiliation: Instituto de Salud Músculo Esquelética
responsible party type: Sponsor-Investigator
investigator affiliation: University of Valladolid
investigator full name: Rafael J. Curbelo
investigator title: PhD
mesh term: Urinary Incontinence
mesh term: Enuresis