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Individual Pelvic Floor Muscle Training Versus Individual With Group Versus Group for Stress Urinary Incontinence

NCT02664714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-01-27

No results posted yet for this study

Summary

The aim of this study is to evaluate if the training of pelvic floor muscles, which associates an individualized treatment progressing to a group treatment, would be more effective than an individualized training only or groups only.

Methods: Randomized controlled study which will be done from January to December of 2016, on Laboratory of Women's Health Research, Federal University of São Carlos-SP, Brazil.

Inclusion criteria: women with stress UI, older than 18 years old. The sample size calculation was performed using the GPower Software (3.1.5, Germany) and it was estimated a sample of 30 women in each group. The volunteers will be assessed before the intervention by a urinary symptoms evaluation form, King's Health Questionnaire, miccional diary, PERFECT scheme and perineometry.

After the evaluation will be performed the randomization of the volunteers by a blinded investigator and the volunteers will be allocated into three groups:

Group 1: Individualized Training Group 2: Individualized training with progression to group training Group 3: Group training only

For all groups it will be used the same protocol that was prepared according to the recommendations of the American College of Sports Medicine. Later, volunteers will be reassessed after 12 treatments, three months and six months (from the discharge date). It will be added in the reassessment the Self-efficacy Scale for Pelvic Floor Exercises Practice.

Primary outcome: severity measures of the King's Health Questionnaire.

Secondary outcome: miccional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice. Data normality will be tested by the Shapiro-Wilk test (SPSS 19.0). The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent measures). In order to measure the practical significance of the data, the effect size and the confidence interval (CI) will be calculated. A 5% significance level will be assumed. This study was approved by the Research Ethics Committee of the Federal University of São Carlos, São Carlos- SP, Brazil (Protocol 1207393).

Conditions

  • Urinary Incontinence Stress

Interventions

OTHER

PFMT

Participating volunteers of all groups will receive guidance about the anatomy and function of the pelvic floor muscles (PFM) and how to perform a properly contraction: as strong as possible and eliminating at the most the contraction of the gluteus, abdominals and adductors. For all groups it will be used the same protocol which was developed for this study, with progression parameters of the PFMT based on the recommendations for the strength training of the American College of Sports Medicine (VICKI, 2001).

Sponsors & Collaborators

  • Universidade Federal de Sao Carlos

    lead OTHER

Principal Investigators

  • Vilena F Xavier · Programa de Pós-Graduação em Fisioterapia - UFSCar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02664714 on ClinicalTrials.gov