Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women (UVa_1)
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|ClinicalTrials.gov Identifier: NCT02212418|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
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|
|Mild Pelvic Floor Dysfunction||Other: Abdominal hypopressive technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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 :||March 2013|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||August 2013|
|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
- change of pelvic floor tone at 2 months and after 4 months [ Time Frame: 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
- change of urinary incontinence at 2 months and after 4 months [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212418
|Principal Investigator:||Lidon Soriano, PhD||Universidad Alfonso X el Sabio|
|Principal Investigator:||Rafael J Curbelo, PhD||University of Valladolid|
|Study Director:||Loreto Carmona, PhD||Instituto de Salud Músculo Esquelética|