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Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women (UVa_1)

Primary Purpose

Mild Pelvic Floor Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Abdominal hypopressive technique
Sponsored by
Rafael J. Curbelo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Pelvic Floor Dysfunction

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month)
  • between 20 and 65 years old
  • with availability for three afternoons per week.

Exclusion Criteria:

  • hypertension
  • serious diseases
  • pregnancy
  • postpartum phase up to 2 months after delivery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Abdominal hypopressive technique

    Arm Description

    Outcomes

    Primary Outcome Measures

    change of pelvic floor tone at 2 months and after 4 months
    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

    Secondary Outcome Measures

    change of urinary incontinence at 2 months and after 4 months
    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.

    Full Information

    First Posted
    August 2, 2014
    Last Updated
    August 6, 2014
    Sponsor
    Rafael J. Curbelo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02212418
    Brief Title
    Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women
    Acronym
    UVa_1
    Official Title
    Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rafael J. Curbelo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Pelvic Floor Dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Abdominal hypopressive technique
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Abdominal hypopressive technique
    Intervention Description
    postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible
    Primary Outcome Measure Information:
    Title
    change of pelvic floor tone at 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
    Time Frame
    at baseline, after 2 months, and after 4 months
    Secondary Outcome Measure Information:
    Title
    change of urinary incontinence at 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.
    Time Frame
    perfomed at baseline, after 2 months, and after 4 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month) between 20 and 65 years old with availability for three afternoons per week. Exclusion Criteria: hypertension serious diseases pregnancy postpartum phase up to 2 months after delivery.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lidon Soriano, PhD
    Organizational Affiliation
    Alfonso X El Sabio University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Rafael J Curbelo, PhD
    Organizational Affiliation
    University of Valladolid
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Loreto Carmona, PhD
    Organizational Affiliation
    Instituto de Salud Músculo Esquelética
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women

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