Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy

Urinary Incontinence Clinical Trial

— HEPFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259712
• Other study ID #: OE 20/2013
• Secondary ID: OE 20/2013
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: March 2020

Study information

• Verified date: December 2023
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2020
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women who experience signs and symptoms evidencing pelvic floor dysfunction.

• Women with a medical diagnosis of pelvic floor dysfunction.

• Women with signs and or symptoms of urinary incontinence, anal incontinence, overactive bladder syndrome and prolapse in grade I-II.

• All participants must understand and sign freely Informed Consent.

Exclusion Criteria:

• Women minors.

• Pregnant women.

• Women who have had a vaginal delivery or cesarean in the past six months.

• Women with pelvic floor dysfunction which is serious and the first indication is surgical (prolapses grades III-IV).

• Women who have been treated for perineal physiotherapy in the past 12 months.

• Participants submit any pathology that may affect treatment (neurological, gynecological or urological), or recurrent urinary tract infection or hematuria.

• Women with cognitive limitations in understanding the information, respond to questionnaires, consent and / or participate in the study.

Related Conditions & MeSH terms

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

Intervention

Other:
• Hypopressive exercises
45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.

Behavioral:
• Therapeutic education.
The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions. In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant.

Other:
• Pelvic-perineal physiotherapy
45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.
• Physical Therapy assessment
Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.

Locations

Country	Name	City	State
Spain	Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of signs, symptoms and impact of pelvic floor dysfunction between reviews	- Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).	Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Primary	The change of signs, symptoms and impact of pelvic floor dysfunction between reviews	- Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).	Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Secondary	The change of pelvic floor muscles strenght	- Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.	Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.
Secondary	The change of pelvic floor muscles pressure force	- Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.	Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

External Links

•   Women's Health Research Group Info