NCT02073721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

June 1, 2013

Last Update Submit

February 25, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • urinary incontinence

    august/2013 to December/2013 (4 months)

Study Arms (2)

electrostimulation with exercises MAPs

EXPERIMENTAL

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

exercises MAPs

ACTIVE COMPARATOR

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

Other: exercises MAPs

Interventions

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.

Also known as: electrostimulation and exercises of the pelvic floor muscles
electrostimulation with 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.

Also known as: exercises of the pelvic floor muscles
exercises MAPs

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Hospital Servants of the State of Rio de Janeiro

Rio de Janeiro, RJ/Rio de Janeiro, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patrícia Z Barros, expert

    Gama Filho University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Electrostimulation exercises of the pelvic floor muscles AND URINARY INCONTINENCE IN POST prostatectomy: Randomised controlled trial, double blind

Study Record Dates

First Submitted

June 1, 2013

First Posted

February 27, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations