<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/NCT02259712</url>
  </required_header>
  <id_info>
    <org_study_id>OE 20/2013</org_study_id>
    <secondary_id>OE 20/2013</secondary_id>
    <nct_id>NCT02259712</nct_id>
  </id_info>
  <brief_title>Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy</brief_title>
  <acronym>HEPFD</acronym>
  <official_title>Randomized Clinical Trial on the Effectiveness of Hipopressive Exercises Versus Classical Perineal Physiotherapy in Women With Pelvic Floor Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Hipopressive Exercises are included within a method of physiotherapy which was&#xD;
      created with the purpose of strengthening the deep muscles of the abdomen without damaging&#xD;
      ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic&#xD;
      floor reflexively. Although this technique has been included as treatment and a prevention&#xD;
      method of pelvic floor dysfunction, there are few studies supporting its benefits. The&#xD;
      investigators hypotthesis is that the combination of both physical therapy treatments will&#xD;
      provided the best results for women who suffer pelvic floor dysfunctions.&#xD;
&#xD;
      Objective: To determine whether Hipopressive Exercises are an option to include in the&#xD;
      physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the&#xD;
      results reported are comparable to those provided by the classical perineal physiotherapy.&#xD;
&#xD;
      Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the&#xD;
      intervention group to which subjects were assigned. Participants will be randomly assigned to&#xD;
      three groups:&#xD;
&#xD;
        1. An experimental group, where the participants will be treated by Hipopressive exercises&#xD;
           and hygienic and behavioral measures;&#xD;
&#xD;
        2. Another experimental group where classical perineal physiotherapy will join with&#xD;
           Hipopressive exercises and hygienic and behavioral advises;&#xD;
&#xD;
        3. And a third group where will be done classical perineal physiotherapy and hygienic and&#xD;
           behavioral measures.&#xD;
&#xD;
      Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made.&#xD;
      The selection criteria will be: adult women who present signs and symptoms that indicate a&#xD;
      pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must&#xD;
      understand and sign freely Informed Consent.&#xD;
&#xD;
      Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast,&#xD;
      26 subjects were required in each group to detect a difference equal to or greater than 3&#xD;
      microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the&#xD;
      rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).&#xD;
&#xD;
      Data Analysis: A descriptive analysis of all variables was performed. It establish for all&#xD;
      cases a confidence level of 95% (p &lt;0.05). The effectiveness was assessed by comparing the&#xD;
      experienced change of the three goups in outcome variables between physicaltherapy&#xD;
      examinations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>The change of signs, symptoms and impact of pelvic floor dysfunction between reviews</measure>
    <time_frame>Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.</time_frame>
    <description>- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of signs, symptoms and impact of pelvic floor dysfunction between reviews</measure>
    <time_frame>Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.</time_frame>
    <description>- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of pelvic floor muscles strenght</measure>
    <time_frame>Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.</time_frame>
    <description>- Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of pelvic floor muscles pressure force</measure>
    <time_frame>Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.</time_frame>
    <description>- Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Pelvic Floor Disorders</condition>
  <condition>Urinary Incontinence</condition>
  <condition>Fecal Incontinence</condition>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Pelviperineal physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in:&#xD;
Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity).&#xD;
Hygienic and behavioral advises preventing pelvic floor dysfunctions.&#xD;
Awareness of the pelvic floor muscles.&#xD;
Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary.&#xD;
Treatment the abdominal-pelvic cavity pain if it requires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hiporessive and Pelviperineal PT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hipopressive exercises and by specific physicaltherapy for the strengthening the pelvic floor muscles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hipopressive exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hipopressive exercises in standing, sitting, and supine fours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hipopressive exercises</intervention_name>
    <description>45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.</description>
    <arm_group_label>Hipopressive exercises</arm_group_label>
    <arm_group_label>Hiporessive and Pelviperineal PT</arm_group_label>
    <other_name>Hipopressive kinesiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapeutic education.</intervention_name>
    <description>The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions.&#xD;
In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant.</description>
    <arm_group_label>Hipopressive exercises</arm_group_label>
    <arm_group_label>Hiporessive and Pelviperineal PT</arm_group_label>
    <arm_group_label>Pelviperineal physiotherapy</arm_group_label>
    <other_name>Hygienic and behavioral advises.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pelviperineal physiotherapy</intervention_name>
    <description>45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.</description>
    <arm_group_label>Hiporessive and Pelviperineal PT</arm_group_label>
    <arm_group_label>Pelviperineal physiotherapy</arm_group_label>
    <other_name>Specific physical therapy.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy assessment</intervention_name>
    <description>Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.</description>
    <arm_group_label>Hipopressive exercises</arm_group_label>
    <arm_group_label>Hiporessive and Pelviperineal PT</arm_group_label>
    <arm_group_label>Pelviperineal physiotherapy</arm_group_label>
    <other_name>Physiotherapy evaluation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who experience signs and symptoms evidencing pelvic floor dysfunction.&#xD;
&#xD;
          -  Women with a medical diagnosis of pelvic floor dysfunction.&#xD;
&#xD;
          -  Women with signs and or symptoms of urinary incontinence, anal incontinence,&#xD;
             overactive bladder syndrome and prolapse in grade I-II.&#xD;
&#xD;
          -  All participants must understand and sign freely Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women minors.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Women who have had a vaginal delivery or cesarean in the past six months.&#xD;
&#xD;
          -  Women with pelvic floor dysfunction which is serious and the first indication is&#xD;
             surgical (prolapses grades III-IV).&#xD;
&#xD;
          -  Women who have been treated for perineal physiotherapy in the past 12 months.&#xD;
&#xD;
          -  Participants submit any pathology that may affect treatment (neurological,&#xD;
             gynecological or urological), or recurrent urinary tract infection or hematuria.&#xD;
&#xD;
          -  Women with cognitive limitations in understanding the information, respond to&#xD;
             questionnaires, consent and / or participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatriz N Navarro, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alcala</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Beatriz N Navarro, PhD student</last_name>
    <phone>+34918854828</phone>
    <email>b.navarrobrazalez@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>María T Torres, PhD</last_name>
    <phone>+34918854828</phone>
    <email>maria.torres@uah.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beatriz N Navarro, PhD student</last_name>
      <phone>+34-91-885-48-28</phone>
      <email>b.navarrobrazalez@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>María T Torres, PhD</last_name>
      <phone>+34-91-885-48-28</phone>
      <email>maria.torres@uah.es</email>
    </contact_backup>
    <investigator>
      <last_name>Beatriz N Navarro, PhD student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www2.uah.es/fisioterapia_saludmujer/</url>
    <description>Research Group Info</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Beatriz Navarro Brazález</investigator_full_name>
    <investigator_title>Physical Therapy researcher</investigator_title>
  </responsible_party>
  <keyword>Women</keyword>
  <keyword>Pelvic floor disorders</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Fecal incontinence</keyword>
  <keyword>Physical Therapy Modalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Pelvic Floor Disorders</mesh_term>
    <mesh_term>Pelvic Pain</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/NCT02259712
org study id: OE 20/2013
secondary id: OE 20/2013
nct id: NCT02259712
lead sponsor: 
has dmc: Yes
Introduction: Hipopressive Exercises are included within a method of physiotherapy which was
      created with the purpose of strengthening the deep muscles of the abdomen without damaging
      ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic
      floor reflexively. Although this technique has been included as treatment and a prevention
      method of pelvic floor dysfunction, there are few studies supporting its benefits. The
      investigators hypotthesis is that the combination of both physical therapy treatments will
      provided the best results for women who suffer pelvic floor dysfunctions.

      Objective: To determine whether Hipopressive Exercises are an option to include in the
      physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the
      results reported are comparable to those provided by the classical perineal physiotherapy.

      Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the
      intervention group to which subjects were assigned. Participants will be randomly assigned to
      three groups:

        1. An experimental group, where the participants will be treated by Hipopressive exercises
           and hygienic and behavioral measures;

        2. Another experimental group where classical perineal physiotherapy will join with
           Hipopressive exercises and hygienic and behavioral advises;

        3. And a third group where will be done classical perineal physiotherapy and hygienic and
           behavioral measures.

      Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made.
      The selection criteria will be: adult women who present signs and symptoms that indicate a
      pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must
      understand and sign freely Informed Consent.

      Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast,
      26 subjects were required in each group to detect a difference equal to or greater than 3
      microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the
      rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).

      Data Analysis: A descriptive analysis of all variables was performed. It establish for all
      cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the
      experienced change of the three goups in outcome variables between physicaltherapy
      examinations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
description: - Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).
measure: The change of signs, symptoms and impact of pelvic floor dysfunction between reviews
time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
description: - Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).
measure: The change of pelvic floor muscles strenght
time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
description: - Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.
measure: The change of pelvic floor muscles pressure force
time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
description: - Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.
arm group label: Pelviperineal physiotherapy
arm group type: Active Comparator
description: The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in:
Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity).
Hygienic and behavioral advises preventing pelvic floor dysfunctions.
Awareness of the pelvic floor muscles.
Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary.
Treatment the abdominal-pelvic cavity pain if it requires.
arm group label: Hiporessive and Pelviperineal PT
arm group type: Experimental
description: The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hipopressive exercises and by specific physicaltherapy for the strengthening the pelvic floor muscles.
arm group label: Hipopressive exercises
arm group type: Experimental
description: The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hipopressive exercises in standing, sitting, and supine fours.
intervention type: Other
intervention name: Hipopressive exercises
description: 45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.
arm group label: Hipopressive exercises
arm group label: Hiporessive and Pelviperineal PT
other name: Hipopressive kinesiotherapy
intervention type: Behavioral
intervention name: Therapeutic education.
description: The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions.
In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant.
arm group label: Hipopressive exercises
arm group label: Hiporessive and Pelviperineal PT
arm group label: Pelviperineal physiotherapy
other name: Hygienic and behavioral advises.
intervention type: Other
intervention name: Pelviperineal physiotherapy
description: 45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.
arm group label: Hiporessive and Pelviperineal PT
arm group label: Pelviperineal physiotherapy
other name: Specific physical therapy.
intervention type: Other
intervention name: Physical Therapy assessment
description: Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.
arm group label: Hipopressive exercises
arm group label: Hiporessive and Pelviperineal PT
arm group label: Pelviperineal physiotherapy
other name: Physiotherapy evaluation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Beatriz N Navarro, PhD student
role: Principal Investigator
affiliation: University of Alcala
last name: Beatriz N Navarro, PhD student
phone: +34918854828
email: b.navarrobrazalez@gmail.com
last name: María T Torres, PhD
phone: +34918854828
email: maria.torres@uah.es
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Spain
url: http://www2.uah.es/fisioterapia_saludmujer/
description: Research Group Info
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Beatriz Navarro Brazález
investigator title: Physical Therapy researcher
mesh term: Fecal Incontinence
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Pelvic Floor Disorders
mesh term: Pelvic Pain