<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/NCT03247660</url>
  </required_header>
  <id_info>
    <org_study_id>21/2013</org_study_id>
    <nct_id>NCT03247660</nct_id>
  </id_info>
  <brief_title>Perineal Physiotherapy in Postpartum</brief_title>
  <acronym>PT-POSTPARTO</acronym>
  <official_title>Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and&#xD;
      treatment of postpartum pelvic floor dysfunction caused by vaginal delivery. Design:&#xD;
      Randomized, controlled and single blinded clinical trial. Participants will be randomly&#xD;
      assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus&#xD;
      hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive&#xD;
      exercises plus training in lifestyle advice; Control group: just training in lifestyle&#xD;
      advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before&#xD;
      intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3,&#xD;
      6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery),&#xD;
      primiparous, whose vaginal delivery has occurred in the &quot;PrÍncipe de Asturias&quot; Hospital,&#xD;
      which have not been already treated for pelvic floor dysfunction, and after reading,&#xD;
      understanding and freely signing an informed consent form. Sample size: 240 subjects will be&#xD;
      included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that&#xD;
      17% of women in the intervention group may develop pelvic floor dysfunction (urinary&#xD;
      incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1&#xD;
      in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive&#xD;
      analysis will be done of all variables. A confidence level of 95% (p &lt;0,05) will be&#xD;
      established for all the cases. Effectiveness will be evaluated by comparing between the two&#xD;
      groups of the change in outcome variables between visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>
    <intervention_model_description>3 groups: 2 experimental groups and 1 control group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in life impact of pelvic floor dysfunction</measure>
    <time_frame>5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.</time_frame>
    <description>It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in symptoms and quality of life</measure>
    <time_frame>5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.</time_frame>
    <description>It will be assessed by PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pelvic floor muscle strength</measure>
    <time_frame>5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.</time_frame>
    <description>It will be measured with manometry (cm2O2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pelvic floor muscle characteristics</measure>
    <time_frame>5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.</time_frame>
    <description>Vaginal palpation will qualify PFM condition using the Levator any test (LAT) ranging from 0 to 5, according to the muscles strength and endurance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pelvic floor muscle strength</measure>
    <time_frame>5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.</time_frame>
    <description>It will be measured with dynamometry (gr)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Post Partum</condition>
  <arm_group>
    <arm_group_label>PFMT&amp;HE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A directly pelvic floor muscle (PFM) training protocol will be applied. Participants will performed PFM exercises in the way proposed by the PERFECT scheme. Biofeedback exercises will be also performed in lithotomy position. If the evolution of the women will allow it, the last two treatment biofeedback sessions will be conducted in standing position, to train PFM in more challenging and functional situation. In this group participants will be also trained hypopressive breathing and will perform five hypopressive exercises: two postures in supine, one on four-kneeling, and two in standing position. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus Educational strategy.&#xD;
The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The educational strategy will consist of instruction of printed materials and dimensional anatomical models about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, weight lifting, high impact sports, constipation, smoking, or drinking too much caffeine. They will also instruct in toilet habits, and will be taught to use the knack maneuver before and during increases of intra-abdominal pressure. The intervention will last 8 weeks, 1 session per week. Each session will last 40/50 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PFM training</intervention_name>
    <description>See information included in arm/group descriptions.</description>
    <arm_group_label>PFMT&amp;HE group</arm_group_label>
    <other_name>Pelvic floor muscle training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HE</intervention_name>
    <description>See information included in arm/group descriptions.</description>
    <arm_group_label>HE group</arm_group_label>
    <arm_group_label>PFMT&amp;HE group</arm_group_label>
    <other_name>Hypopressive exercises</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Educational strategy</intervention_name>
    <description>See information included in arm/group descriptions.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>HE group</arm_group_label>
    <arm_group_label>PFMT&amp;HE group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postnatal women (6 and 8 weeks after vaginal delivery)&#xD;
&#xD;
          -  Primiparous&#xD;
&#xD;
          -  Whose vaginal delivery has occurred in the &quot;Príncipe de Asturias&quot; Hospital&#xD;
&#xD;
          -  Women have not been already treated for pelvic floor dysfunction&#xD;
&#xD;
          -  Women reading, understanding and freely signing an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to&#xD;
             pregnancy and delivery&#xD;
&#xD;
          -  Women with a history of conservative treatment or PFD surgery&#xD;
&#xD;
          -  Women with concomitant or systemic disease that may affect the treatment&#xD;
             (neurological, gynecological, urological or connective tissue), or with active or&#xD;
             recurrent urinary infection without treatment at the time of the intervention proposed&#xD;
             in this study, or hematuria&#xD;
&#xD;
          -  Postnatal women with cognitive limitations to understand 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>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>María Torres-Lacomba, PhD</last_name>
    <email>maria.torres@uah.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Beatriz Navarro-Brazález, PhD</last_name>
    <email>b.navarrobrazalez@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alcalá. FPSM research group. HUPA</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Torres-Lacomba, PhD</last_name>
      <email>maria.torres@uah.es</email>
    </contact>
    <contact_backup>
      <last_name>Beatriz Navarro-Brazález, PhD</last_name>
      <email>b.navarrobrazalez@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Maria Torres Lacomba</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03247660
org study id: 21/2013
nct id: NCT03247660
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and
      treatment of postpartum pelvic floor dysfunction caused by vaginal delivery. Design:
      Randomized, controlled and single blinded clinical trial. Participants will be randomly
      assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus
      hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive
      exercises plus training in lifestyle advice; Control group: just training in lifestyle
      advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before
      intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3,
      6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery),
      primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital,
      which have not been already treated for pelvic floor dysfunction, and after reading,
      understanding and freely signing an informed consent form. Sample size: 240 subjects will be
      included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that
      17% of women in the intervention group may develop pelvic floor dysfunction (urinary
      incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1
      in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive
      analysis will be done of all variables. A confidence level of 95% (p <0,05) will be
      established for all the cases. Effectiveness will be evaluated by comparing between the two
      groups of the change in outcome variables between visits.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 3 groups: 2 experimental groups and 1 control group
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Change in life impact of pelvic floor dysfunction
time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
description: It will be assessed by the PFIQ-7 Spanish version. The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300).
measure: Change in symptoms and quality of life
time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
description: It will be assessed by PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse quality of life. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms.
measure: Change in pelvic floor muscle strength
time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
description: It will be measured with manometry (cm2O2)
measure: Change in pelvic floor muscle characteristics
time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
description: Vaginal palpation will qualify PFM condition using the Levator any test (LAT) ranging from 0 to 5, according to the muscles strength and endurance.
measure: Change in pelvic floor muscle strength
time frame: 5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
description: It will be measured with dynamometry (gr)
arm group label: PFMT&HE group
arm group type: Experimental
description: A directly pelvic floor muscle (PFM) training protocol will be applied. Participants will performed PFM exercises in the way proposed by the PERFECT scheme. Biofeedback exercises will be also performed in lithotomy position. If the evolution of the women will allow it, the last two treatment biofeedback sessions will be conducted in standing position, to train PFM in more challenging and functional situation. In this group participants will be also trained hypopressive breathing and will perform five hypopressive exercises: two postures in supine, one on four-kneeling, and two in standing position. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.
arm group label: HE group
arm group type: Experimental
description: Women will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus Educational strategy.
The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.
arm group label: Control group
arm group type: Active Comparator
description: The educational strategy will consist of instruction of printed materials and dimensional anatomical models about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, weight lifting, high impact sports, constipation, smoking, or drinking too much caffeine. They will also instruct in toilet habits, and will be taught to use the knack maneuver before and during increases of intra-abdominal pressure. The intervention will last 8 weeks, 1 session per week. Each session will last 40/50 minutes.
intervention type: Other
intervention name: PFM training
description: See information included in arm/group descriptions.
arm group label: PFMT&HE group
other name: Pelvic floor muscle training
intervention type: Other
intervention name: HE
description: See information included in arm/group descriptions.
arm group label: HE group
arm group label: PFMT&HE group
other name: Hypopressive exercises
intervention type: Behavioral
intervention name: Educational strategy
description: See information included in arm/group descriptions.
arm group label: Control group
arm group label: HE group
arm group label: PFMT&HE group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: María Torres-Lacomba, PhD
email: maria.torres@uah.es
last name: Beatriz Navarro-Brazález, PhD
email: b.navarrobrazalez@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Maria Torres Lacomba
investigator title: Professor
sharing ipd: No