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).
| Status | Not yet recruiting |
| Enrollment | 90 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Federal de Sao Carlos |
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | severity measures of the King's Health Questionnaire | In the first assessment volunteers will answer the King's Health Questionnaire | 6 months | No |
| Secondary | mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice | the volunteer will be placed in the supine position with flexed hip and knees. Initially, it will be observed the vaginal mucosa condition, the presence of atrophies, sensitivity, pelvic organ prolapse and the tone of the vaginal wall. Then, it will be performed the muscle function evaluation through the PERFECT scale which was developed, the researcher will introduce the index finger about 4 cm into the volunteer vaginal canal and will guide her to contract the PFM.After, it will be evaluated the pelvic floor muscles contraction pressure through the Peritron equipment (Cardio Design,Australia) and is equipped with a vaginal probe. The perineometer probe will be coated with a male non-lubricated condom and will be introduced with KY® lubricant gel into the volunteer's vagina. | 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 3 |