Clinical trial NCT02664714: Individual Pelvic Floor Muscle Training Versus Individual With Group Versus Group for Stress Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence Stress
Keywords: physiotherapy, perineometer, adherence
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* women from the age of 18 years old who present urinary incontinence stress

Exclusion Criteria:

* urge urinary incontinence (UUI) in an isolated form, neuromuscular diseases, other diseases (asthma, tumors, heart failure, absence of pelvic floor muscle contraction (grade 0) verified by modified Oxford scale, urinary infection, difficulty in understanding the study procedures, uncontrolled hypertension, presence of severe prolapse (visible prolapse in the vaginal opening), women with UI who have done physical therapy in the last 12 months, pregnancy,puerperium.

Primary outcomes:
measure: severity measures of the King's Health Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Programa de Pós-Graduação em Fisioterapia - UFSCar
name: Vilena F Xavier
role: PRINCIPAL_INVESTIGATOR
References:
citation: BØ K, LARSEN S, OSEID S, et al. Knowledge about and ability to correct pelvic floor muscle exercises in women with urinary stress incontinence. Neurourol Urodyn. 1988;7:261-262. BØ K, TALSETH T, VINSNES A: Randomized controlled trial on the effect of pelvic floor muscle training on the quality of life and sexual problems in genuine stress incontinent women. Acta Obstet Gynecol Scand, 79:598-603, 2000. BO K, SHERBURN M. Evaluation of female pelvic-floor muscle function and strength. Phys Ther; 85 (3): 269 -82, 2005. BØ, K. AND HILDE, G. Does it work in the long term?-A systematic review on pelvic floor muscle training for female stress urinary incontinence. Neurourol. Urodyn., 32: 215-223, 2013. BORELLO-FRANCE DF, ZYCZYNSKI HM, DOWNEY PA, RAUSE CR, WISLER JA. Effect of pelvic floor muscles exercise position on continence and quality of life outcomes in women with stress urinary incontinence.Phys Ther. 86:974-86, 2006.