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

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders; Quality of Life; Urinary Incontinence

• Registration Number: NCT04339010
• Lead Sponsor: University of the State of Santa Catarina

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.

Detailed Description

This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women. The study was approved by the Research Ethics of Santa Catarina State University (number 3.712.850) and each participating provided the written informed consent signed. Women were randomly assigned to either an AHT group or the AHT associated with PFM contraction (AHT + PFMC) group. The first group underwent a hypopressive exercise program that does not stimulate the PFM contraction, while the other group receives the AHT associated with PFM contraction stimulated by the physiotherapist during the sessions. Following eligibility screening by the research, the women were allocated in an of the two groups. Group allocation results were concealed by opaque, sealed envelopes with serial numbers, and the participants were assigned at the second visit by opening envelops in a sequential manner, after their eligibility was assessed at the first visit. Study investigators were blinded to treatment allocation. Participants underwent a five weeks intervention after the first evaluation, and the final evaluation occurred one week later on a date according to the participant availability.

The first three sessions were designated to learn how to perform the exercises and your variations correctly were part of the five weeks intervention. The intervention was performed in a forty-minute training session in two-week meetings during five consecutive weeks. All women included in this trial, independently of the group, received standardized lifestyle advice including, when appropriate, instructions about weight loss, constipation, hydration and the avoidance of heavy lifting. It is very important to emphasize that the time dedicated to performing the daily exercises was similar. The therapist applying the protocol was appropriately trained especially for the trial and it was not the same professional who conducted the evaluations.

Study Timeline

• Study Start: 2019-12-02
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-07
• Last Update Submitted: 2020-04-07
• Study First Posted: 2020-04-08
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

18 years old and older, and having a complaint or diagnosis of urinary incontinence.

Exclusion Criteria

women will be excluded if they had diseases affecting the muscular and nerve tissues, chronic degenerative and/or cerebrovascular disease, or neurological conditions, or had previously undergone pelvic floor re-education programs. Besides that, only women with the ability to correctly contract their PFM proceeded to intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urinary incontinence symptoms	Pre intervention and 1 week post intervention	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".

Secondary Outcome Measures

Name	Time	Method
Vaginal resting pressure	Pre intervention and 1 week post intervention	The Peritron manometer will be inserted into the vaginal canal and a rest period was given to control the influence of possible voluntary and involuntary contractions, in order to obtain the vaginal resting pressure measurement . The vaginal resting pressure value will be determined by the lowest pressure value during rest.
Maximal voluntary contraction	Pre intervention and 1 week post intervention	Peritron 9300® manometer will be used to assess the maximum voluntary contraction (MVC). An MVC of PFM will be asked to the participant and the peak value was recorded, this process was repeated 3 times. The mean value of these three pressure peaks corresponded to MVC of the PFM.

Trial Locations

Locations (1)

Center for Health and Sport Sciences; 🇧🇷 Florianópolis, Santa Catarina, Brazil