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

January 22, 2016 updated by: Vilena Figueiredo Xavier, Universidade Federal de Sao Carlos

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PFMT Individualized
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
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).
Other Names:
  • pelvic floor muscles training
Experimental: PFMT individualized with group
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
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).
Other Names:
  • pelvic floor muscles training
Active Comparator: 12 group PFMT
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
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).
Other Names:
  • pelvic floor muscles training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity measures of the King's Health Questionnaire
Time Frame: 6 months
In the first assessment volunteers will answer the King's Health Questionnaire
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mictional diary, PERFECT scheme, perineometry and Self-efficacy scale for Pelvic Floor Exercises Practice
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Investigators

  • Principal Investigator: Vilena F Xavier, Programa de Pós-Graduação em Fisioterapia - UFSCar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 16, 2015

First Submitted That Met QC Criteria

January 22, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5015537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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