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
About this trial
This is an interventional treatment trial for Mild Pelvic Floor Dysfunction
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.
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
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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