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

NCT02664714 | Unknown DMC

• 1 other identifier: 5015537
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Urinary Incontinence Stress

Keywords

physiotherapy, perineometer, adherence

Outcome Measures

Primary Outcomes (1)

• severity measures of the King's Health Questionnaire

  In the first assessment volunteers will answer the King's Health Questionnaire

  6 months

Secondary Outcomes (1)

• mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice

  6 months

Study Arms (3)

PFMT Individualized

ACTIVE COMPARATOR

12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s) 4(5s/10s), 5(5s/5s), 6(5s/5s), 7(6s/6s),8(6s/6s), 9(8s/8s) 10(8s/8s), 11(10s/10s),12(10s/10s)

Other: PFMT

PFMT individualized with group

EXPERIMENTAL

12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s)

Other: PFMT

12 group PFMT

ACTIVE COMPARATOR

12 Individualized pelvic floor muscle training:FAST CONTRACTIONS(repetitions) weeks 1(5x),2(10x),3(15x), 4(20x),5(30x),6(40x) 7-12(50x)SUSTAINED CONTRACTIONSNumber of series:weeks: 1 and 2(2), 3-6(3), 7-12(4)Repetitions:week 1(6) week 2(8), weeks 3-12 (10)Sustained contraction time/Resting time: weeks 1(2s/4s),2(3s/6s), 3(4s/8s)

Other: PFMT

Interventions

PFMT OTHER

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).

Also known as: pelvic floor muscles training

12 group PFMT; PFMT Individualized; PFMT individualized with group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Related Publications (2)

• 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.

  BACKGROUND

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

Related Links

• test link

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vilena F Xavier

  Programa de Pós-Graduação em Fisioterapia - UFSCar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vilena F Xavier

CONTACT

55-85996239673; vilenabf@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 27, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 27, 2016

Record last verified: 2016-01