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

Urinary Incontinence Clinical Trial

— UI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073721
• Other study ID #: 260535
• Status: Completed
• Phase: N/A
• First received: June 1, 2013
• Last updated: February 25, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Universidade Gama Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal Hospital Servants of the State of Rio de Janeiro	Rio de Janeiro	RJ/Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Gama Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary incontinence		august/2013 to December/2013 (4 months)	Yes