The Effects of Pilates in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence

December 30, 2015 updated by: Cíntia Spagnolo Gomes, Universidade Estadual de Londrina

The Effects of Pilates Method in Muscle Strength of the Pelvic Floor as Treatment of Post Prostatectomy Urinary Incontinence: : a Randomized Control Trial

The purpose of this study is to compare the efficacy between a Pilates exercise program and a Pelvic Floor Muscle Training (PFMT) protocol combined with anal electrical stimulation (AES) in muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

Study Overview

Detailed Description

This randomized clinical trial includes 115 individuals with urinary incontinence one month after radical prostatectomy. One physiotherapist, with experience in urogynecology, was responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour pad test and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) were the variables evaluated.

The subjects were allocated in one of three treatment groups (G1: Pilates; G2: anal electrical stimulation combined with pelvic floor muscle training and G3: Control Group).

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Volunteers between 50 and 75 years old;
  • Submitted to radical prostatectomy;
  • With complaints of urinary incontinence;
  • That completed one month of surgery;

Exclusion Criteria:

  • History of incontinence;
  • Transurethral resection of the prostate;
  • Diagnosis of neurological or cognitive impairment;
  • Subjects who were unable to attend treatment sessions, due to distance or physical limitations.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Control Group
Experimental: PILATES
Weekly Pilates sessions, guided by a specialized physiotherapist. The duration of the treatment was 10 weeks, and each session lasted 45 to 50 minutes. All subjects received instruction to perform specific daily home exercises.
Pilates exercises
Active Comparator: PFMT and AES
For also 10 weeks, the participants went trough anal electrical stimulation (AES) associated with Pelvic Floor Muscle Training (PFMT), supervised by a specialized physiotherapist. All subjects received orientation to perform the same pelvic floor exercises at home.
conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improves muscle strength of the pelvic floor at 3 months
Time Frame: baseline and 3 months
Evaluation of the contraction capacity of the pelvic floor using perineometer (Myomed 932 Enraf/Nonius®)
baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the International Consultation of Urinary Incontinence- Short Form questionnaire at 3 months
Time Frame: baseline and 3 months
baseline and 3 months
Change in Pad test 24 hours at 3 months
Time Frame: baseline and 3 months
baseline and 3 months

Collaborators and Investigators

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

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.

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, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 27, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Estimate)

January 1, 2016

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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