Effect of Hypopressive Gymnastics Associated or Not With Pelvic Floor Muscle Training in Women With Urinary Incontinence

NCT04339010 | Completed

• 1 other identifier: Hypopressive gymnastics
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To verify the effects of the abdominal hypopressive technic (AHT) associate or not with pelvic floor muscle training (PFMT) in urinary incontinence (UI) symptoms and pelvic floor muscle strength. Methods: Randomized controlled trial. Thirteen incontinent women were randomly divided into an AHT group or AHT+PFMC group. Outcome assessment was carried out using digital palpation (modified Oxford grading scale), Peritron perineometer, and the International Consultation Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire. The treatment protocol consisted of five twice-weekly, 40-min one-on-one sessions. The participants were assessed only at baseline and after the intervention. Results: It is expected that the group who performed PFMC will improve the maximal voluntary contractions (MVC) and improve urinary incontinence symptoms, while the hypopressive exercise does not.

Conditions

Urinary Incontinence; Quality of Life; Pelvic Floor Disorders

Keywords

Pelvic floor; Hypopressive exercise

Outcome Measures

Primary Outcomes (1)

• Urinary incontinence symptoms

  Will be assessed by evaluating the ICIQ-SF questionnaire that assesses the frequency, severity, and impact on the quality of life of urinary incontinence (UI). The three scored items of the ICIQ-UI SF are: \[1\] ''How often do you leak urine?'' (0 ''Never" 1 ''About once a week or less often,'' 2 ''Two or three times a week,'' 3 ''About once a day,'' 4 ''Several times a day,'' 5 ''All the time''), \[2\] ''How much urine do you usually leak?'' (0 ''None,'' 2 ''A small amount,'' 4 ''A moderate amount,'' and 6 ''A large amount''), and \[3\] ''Overall, how much does leaking urine interfere with your everyday life?'' (Visual analog scale ranging from 0 ''Not at all'' to 10 ''A great deal''). The answers result in a sum, with a minimum score of 0, and a maximum score of 21. Preliminary cut-off scores were set to 0 as ''continent status'' and 1 or more as ''incontinence status".

  Pre intervention and 1 week post intervention

Secondary Outcomes (2)

• Maximal voluntary contraction

  Pre intervention and 1 week post intervention

• Vaginal resting pressure

  Pre intervention and 1 week post intervention

Study Arms (2)

Hypopressive

EXPERIMENTAL

1. st session: the meetings were provided by a physiotherapist, who also discussed the location and function of the pelvic organs, PFM, and the transversus abdominis (TrA) muscles. The participants learned how to activate TrA muscles. The training was performed during full expiration, the physiotherapist check and coordinate the group to maintain the Tra contraction. The women were also trained to inhale through the nose and exhale through the mouth maintaining an apical breathing pattern. 2. nd session: The contractions were executed during six different positions the ones which they will keep following through the whole treatment. 3. rd session: The patients were exposed to all the six positions (supplementary material) and their three variations (positions 1, 3, 5 and 6 ). Every meeting obeyed the same schedule through the five weeks of treatment and was accompanied by two physiotherapists.

Other: Hypopressive exercise

Hypopressive + PFMC

ACTIVE COMPARATOR

This group receives the same protocol than the Hypopressive group, but with a verbal command to realize the PFM contraction during the activation of the deep abdominal muscle.

Other: Hypopressive exercise; Other: Pelvic floor muscle contraction

Interventions

Hypopressive exercise OTHER

The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.

Hypopressive; Hypopressive + PFMC

Pelvic floor muscle contraction OTHER

Pelvic floor muscle contraction (PFMC) is performed through a sequence of contraction and relax the PFM. It will improve PFM strength and is effective for treating urinary incontinence.

Hypopressive + PFMC

Eligibility Criteria

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

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Center for Health and Sport Sciences

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

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: Clinical Professor

Model Details: This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women.

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: December 2, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 30, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

BR (1)