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

Primary Purpose

Urinary Incontinence

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

electrostimulation with exercises MAPs

exercises MAPs

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Federal Hospital Servants of the State of Rio de Janeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

electrostimulation with exercises MAPs

exercises MAPs

Arm Description

this group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles.

This group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor

Outcomes

Primary Outcome Measures

urinary incontinence

Secondary Outcome Measures

Full Information

NCT ID

NCT02073721

First Posted

June 1, 2013

Last Updated

February 25, 2014

Sponsor

Universidade Gama Filho

1. Study Identification

Unique Protocol Identification Number

NCT02073721

Brief Title

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

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Gama Filho

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

electrostimulation with exercises MAPs

Arm Type

Experimental

Arm Description

this group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles.

Arm Title

exercises MAPs

Arm Type

Active Comparator

Arm Description

This group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor

Intervention Type

Other

Intervention Name(s)

electrostimulation with exercises MAPs

Other Intervention Name(s)

electrostimulation and exercises of the pelvic floor muscles

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

exercises MAPs

Other Intervention Name(s)

exercises of the pelvic floor muscles

Intervention Description

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.

Primary Outcome Measure Information:

Title

urinary incontinence

Time Frame

august/2013 to December/2013 (4 months)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrícia Z Barros, expert

Organizational Affiliation

Gama Filho University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal Hospital Servants of the State of Rio de Janeiro

City

Rio de Janeiro

State/Province

RJ/Rio de Janeiro

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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