Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy — HEPFD  

Urinary Incontinence Clinical Trial

Official title: Effectiveness of Hypopressive Exercises Versus Pelvic- Perineal Physiotherapy in Women With Pelvic Floor Dysfunction: Randomised, Single-blinded, Clinical Trial.

Status Completed

Clinical Trial Summary

Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypothesis is that the combination of both physiotherapy treatments will provided the best results for women who suffer pelvic floor dysfunctions.

Objective: To determine whether Hypopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by pelvic-perineal physiotherapy.

Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups:

1. An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures;

2. Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises;

3. And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures.

Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent.

Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012).

Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Pelvic Floor Disorders
• Pelvic Pain
• Urinary Incontinence

• NCT number: NCT02259712
• Study type: Interventional
• Source: University of Alcala
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Completion date: March 2020