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NCT Number: NCT02259712

Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy

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.

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Key information

Conditions

Pelvic Floor Disorders Digestive System Diseases Fecal Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Pregnancy Complications Rectal Diseases Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Teacher care and research in physiotherapy Unit. Department of Physiotherapy. University of Alcala.

Alcalá de Henares, Madrid, 28871, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypopressive exercises

Other

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.

Other names: Hypopressive kinesiotherapy

Therapeutic education.

Behavioral

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 names: Hygienic and behavioral advises.

Pelvic-perineal physiotherapy

Other

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.

Other names: Specific physical therapy.

Physical Therapy assessment

Other

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.

Other names: Physiotherapy evaluation

Primary outcomes

  1. The change of signs, symptoms and impact of pelvic floor dysfunction between reviews

    Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

    • Improve the impact of pelvic floor dysfunctions by 30% according to Spanish short version of Pelvic Floor Impact Questionnaire (PFIQ-7).

  2. The change of signs, symptoms and impact of pelvic floor dysfunction between reviews

    Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

    • Improve the signs and symptoms of pelvic floor dysfunction by 30% according to Spanish short version of Pelvic Floor Distress Inventory (PFDI-20).

Secondary outcomes

  1. The change of pelvic floor muscles strenght

    Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

    • Improve the strength of the pelvic floor muscles by 2 points according to the Modified Oxford Scale.

  2. The change of pelvic floor muscles pressure force

    Time frame: Pre-treatment, post-treatment, 3, 6 and 12 months assessments were required.

    • Improve the strength of pelvic floor in 10 cm H2O measured with digital perineometer.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Acronym: HEPFD

Important dates

Study start
2013
Primary completion
2017
Study completion
2020
First posted
Oct 8, 2014
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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