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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
Sponsor:
Information provided by (Responsible Party):
Rafael J. Curbelo, University of Valladolid

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
Mild Pelvic Floor Dysfunction Other: Abdominal hypopressive technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Rafael J. Curbelo
Investigators
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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

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Responsible Party: Rafael J. Curbelo, PhD, University of Valladolid
ClinicalTrials.gov Identifier: NCT02212418     History of Changes
Other Study ID Numbers: UValladolid_1
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders