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

Sponsor
Rafael J. Curbelo (Other)
Overall Status
Completed
CT.gov ID
NCT02212418
Collaborator
(none)
42
1
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Abdominal hypopressive technique
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Intervention Model:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abdominal hypopressive technique

Other: Abdominal hypopressive technique
postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible

Outcome Measures

Primary Outcome Measures

  1. change of pelvic floor tone at 2 months and after 4 months [at baseline, after 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

  1. change of urinary incontinence at 2 months and after 4 months [perfomed at baseline, after 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rafael J. Curbelo

Investigators

  • Principal Investigator: Lidon Soriano, PhD, Alfonso X El Sabio University
  • Principal Investigator: Rafael J Curbelo, PhD, University of Valladolid
  • Study Director: Loreto Carmona, PhD, Instituto de Salud Músculo Esquelética

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rafael J. Curbelo, PhD, University of Valladolid
ClinicalTrials.gov Identifier:
NCT02212418
Other Study ID Numbers:
  • UValladolid_1
First Posted:
Aug 8, 2014
Last Update Posted:
Aug 8, 2014
Last Verified:
Aug 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2014