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

Sponsor

Universidade Gama Filho (Other)

Overall Status

Completed

CT.gov ID

NCT02073721

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Other: electrostimulation with exercises MAPs Other: exercises MAPs	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

urinary incontinence [august/2013 to December/2013 (4 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal Hospital Servants of the State of Rio de Janeiro	Rio de Janeiro	RJ/Rio de Janeiro	Brazil

Sponsors and Collaborators

Universidade Gama Filho

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Patrícia Zaidan de Barros, Electrostimulation exercises of the pelvic floor muscles AND URINARY INCONTINENCE IN POST prostatectomy: Randomised controlled trial, double blind, Universidade Gama Filho

ClinicalTrials.gov Identifier:

NCT02073721

Other Study ID Numbers:

260535

First Posted:

Feb 27, 2014

Last Update Posted:

Feb 27, 2014

Last Verified:

Feb 1, 2014

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Study Results

No Results Posted as of Feb 27, 2014