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

Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial

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.

Study Overview

• Status: Completed
• Conditions: Mild Pelvic Floor Dysfunction
• Intervention / Treatment: Other: Abdominal hypopressive technique

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline, after 2 months, and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	perfomed at baseline, after 2 months, and after 4 months

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 2, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): August 8, 2014
• Last Update Submitted That Met QC Criteria: August 6, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: UValladolid_1