Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy

NCT02259712 | Completed DMC

• 1 other identifier: OE 20/2013
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 1.An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures;
2. 2.Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises;
3. 3.And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures.

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Fecal Incontinence; Pelvic Pain

Keywords

Women; Pelvic floor disorders; Urinary incontinence; Fecal incontinence; Physical Therapy Modalities

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• The change of pelvic floor muscles strenght

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

• The change of pelvic floor muscles pressure force

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

Study Arms (3)

Pelvic-perineal physiotherapy

ACTIVE COMPARATOR

The treatment duration is 2 days per week during 8 weks (two months). The aproximate duration of the season is 45 minutes. The protocol consists in: 1. Anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). 2. Hygienic and behavioral advises preventing pelvic floor dysfunctions. 3. Awareness of the pelvic floor muscles. 4. Strengthening the pelvic floor muscles and the entire abdominal pelvic cavity. Use of electrostimulation and biofeedback in different positions if deemed necessary. 5. Treatment the abdominal-pelvic cavity pain if it requires.

Behavioral: Therapeutic education.; Other: Pelvic-perineal physiotherapy; Other: Physical Therapy assessment

Hyporessive and Pelvic-perineal PT

EXPERIMENTAL

The treatment duration is 2 days per week, 8 weeks (two months). The session is about 45 minutes. All women are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle. The participants are also treated by doing Hypopressive exercises and by specific physiotherapy for the strengthening the pelvic floor muscles.

Other: Hypopressive exercises; Behavioral: Therapeutic education.; Other: Pelvic-perineal physiotherapy; Other: Physical Therapy assessment

Hypopressive exercises

EXPERIMENTAL

The treatment is done 2 times per week for 8 weeks (2 months). The session duration is about 45 minutes. All participants are instructed on hygienic and behavioral advises preventing pelvic floor dysfunctions. They are teach basic anatomy and physiology to understand the importance of these advises and anatomical and physiological explanation of the pelvic girdle (perineal organs bony, ligaments and muscular structures of the entire abdominal and pelvic cavity). The participants are also treated by doing Hypopressive exercises in standing, sitting, and supine fours.

Other: Hypopressive exercises; Behavioral: Therapeutic education.; Other: Physical Therapy assessment

Interventions

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.

Also known as: Hypopressive kinesiotherapy

Hypopressive exercises; Hyporessive and Pelvic-perineal PT

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.

Also known as: Hygienic and behavioral advises.

Hypopressive exercises; Hyporessive and Pelvic-perineal PT; Pelvic-perineal physiotherapy

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.

Also known as: Specific physical therapy.

Hyporessive and Pelvic-perineal PT; Pelvic-perineal physiotherapy

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.

Also known as: Physiotherapy evaluation

Hypopressive exercises; Hyporessive and Pelvic-perineal PT; Pelvic-perineal physiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

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

Alcalá de Henares, Madrid, 28871, Spain

Location

Related Links

• Women's Health Research Group Info

MeSH Terms

Conditions

Pelvic Floor Disorders; Urinary Incontinence; Fecal Incontinence; Pelvic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Beatriz N Navarro, PhD student

  University of Alcala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy researcher

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: October 8, 2014
• Study Start: October 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: March 1, 2020
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

ES (1)