The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Prostatectomy (UI)

February 25, 2014 updated by: Patrícia Zaidan de Barros, Universidade Gama Filho

The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Undergoing Prostatectomy to Exercise the Pelvic Floor Muscles (MAPs): Randomised Controlled Trial, Double Blind

The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be an experiment with active control, randomized, double-blind, parallel intervention. After met the eligibility criteria of the patients will be randomly allocated into two groups: Group exercises MAPs (GEX), which is the active control group and electrostimulation + exercises MAPs (GEEX).

Study Type

Interventional

Enrollment (Actual)

34

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 Locations

  • Brazil
    • RJ/Rio de Janeiro
      • Rio de Janeiro, RJ/Rio de Janeiro, Brazil
        • Federal Hospital Servants of the State of Rio de Janeiro

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patients with urinary sphincter deficiency resulting from a radical prostatectomy surgery
  • sent by urologists the same hospital where the experiment will take place
  • having the maximum time six months after surgery
  • to use 2 to 5 disposable protective per day

Exclusion Criteria:

  • Symptoms of urinary tract infection
  • symptoms of lower urinary tract obstruction
  • anal fistula
  • metallic implant in the body
  • transurethral resection of prostate
  • radiation therapy
  • non-enforcement of the proposed treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electrostimulation with exercises MAPs
this group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles.
Other: electrostimulation with exercises MAPs
this group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles.the frequency will be 20 sessions, 2 times per week, lasting 30 minutes.
Other Names:
  • electrostimulation and exercises of the pelvic floor muscles
Active Comparator: exercises MAPs
This group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor
Other: exercises MAPs
This group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor. the frequency will be 20 sessions, 2 times per week, lasting 30 minutes.
Other Names:
  • exercises of the pelvic floor muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
urinary incontinence
Time Frame: august/2013 to December/2013 (4 months)
august/2013 to December/2013 (4 months)

Collaborators and Investigators

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

Sponsor

Universidade Gama Filho

Investigators

  • Principal Investigator: Patrícia Z Barros, expert, Gama Filho University

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

August 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 1, 2013

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 260535

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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