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

Mild Pelvic Floor Dysfunction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212418
• Other study ID #: UValladolid_1
• Status: Completed
• Phase: N/A
• First received: August 2, 2014
• Last updated: August 6, 2014
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica (CEIE)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mild Pelvic Floor Dysfunction
• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rafael J. Curbelo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No