Clinical trial NCT04339010: Effect of Hypopressive Gymnastics Associated or Not With Pelvic Floor Muscle Training in Women With Urinary Incontinence
Official title: Effect of Hypopressive Gymnastics Associated or Not With Pelvic Floor Muscle Training in Women With Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Quality of Life
Pelvic Floor Disorders
Keywords: Pelvic floor
Hypopressive exercise
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a single-blind randomized controlled trial comparing the effect of AHT versus AHT associated with PFM contraction in incontinent women.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:18 years old and older, and having a complaint or diagnosis of urinary incontinence.

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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.

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Primary outcomes:
measure: Urinary incontinence symptoms
timeFrame: Pre intervention and 1 week post intervention
Secondary outcomes:
measure: Maximal voluntary contraction
timeFrame: Pre intervention and 1 week post intervention
measure: Vaginal resting pressure
timeFrame: Pre intervention and 1 week post intervention
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Center for Health and Sport Sciences
state: Santa Catarina
Study officials:
References: