Urinary Incontinence Stress Clinical Trial
Official title:
The Effects of Individual Pelvic Floor Muscle Training Versus Individual Treatment With Progression to Group Versus Group Training for Women With Stress Urinary Incontinence: Protocol for a Randomized Controlled Trial
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).
This is a blinded randomized controlled clinical trial. Data collection will be performed at
the Women's Health research laboratory (WHRL), allocated in the Department of Physical
Therapy of Federal University of São Carlos, from January 2016 to December 2016.
The project was approved by the Research Ethics Committee (REC) of Federal University of São
Carlos (UFSCar) (Number 1207393). Patients will receive information about the research and
those who consent to participate, will sign the free informed consent form.
The sample size calculation was performed using the GPower Software (3.1.5, Germany) based
on the study of Pereira et al (2011) considering the intergroup comparison of data post
treatment of the severity measurement of the King's Health Questionnaire. It was considered
the ANOVA (repeated measures), 80% power, effect size of 0.40 and 5% of significance level,
being estimated a sample size of 30 subjects.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00191204 -
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
|
Phase 3 |