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

NCT ID: NCT02073721

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

electrostimulation with exercises MAPs

Intervention Type OTHER

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.

exercises MAPs

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

Group Type ACTIVE_COMPARATOR

exercises MAPs

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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electrostimulation and exercises of the pelvic floor muscles exercises of the pelvic floor muscles

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Universidade Gama Filho

OTHER

Sponsor Role lead

Responsible Party

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PatrĂ­cia Zaidan de Barros

Electrostimulation exercises of the pelvic floor muscles AND URINARY INCONTINENCE IN POST prostatectomy: Randomised controlled trial, double blind

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PatrĂ­cia Z Barros, expert

Role: PRINCIPAL_INVESTIGATOR

Gama Filho University

Locations

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Federal Hospital Servants of the State of Rio de Janeiro

Rio de Janeiro, RJ/Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.

Reference Type DERIVED
PMID: 37070660 (View on PubMed)

Other Identifiers

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260535

Identifier Type: -

Identifier Source: org_study_id

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