Urinary IncontinenceUINCT02073721
The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Prostatectomy
A study testing electrostimulation with exercises MAPs and exercises MAPs in people with Urinary Incontinence, run by Universidade Gama Filho at 1 site in Brazil.
Trial summary
The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs) Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- electrostimulation with exercises MAPs and exercises MAPs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal Hospital Servants of the State of Rio de Janeiro
Rio de Janeiro, RJ/Rio de Janeiro
About this study
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
The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs)
Read the 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).
- Conditions
- Urinary Incontinence
- Being tested
- electrostimulation with exercises MAPs, exercises MAPs
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrostimulation with exercises MAPsOther
Also called electrostimulation and exercises of the pelvic floor muscles
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 MAPsOther
Also called exercises of the pelvic floor muscles
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: exercises MAPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary incontinence
Measured: august/2013 to December/2013 (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Gama Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrícia Zaidan de Barros, Universidade Gama Filho
- Investigators
- Patrícia Z Barros, expert, Principal investigator, Gama Filho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073721
- Sponsor's protocol ID
- 260535
- Acronym
- UI
- Status last verified
- Feb 2014
- First submitted
- 1 Jun 2013
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37070660
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02073721
- Acronym / sponsor ID
- UI / 260535
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Gama FilhoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrostimulation with exercises MAPs | Experimental | Other: electrostimulation with exercises MAPsthis group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles. |
| exercises MAPs | Active comparator | Other: exercises MAPsThis group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Symptoms of urinary tract infection
- symptoms of lower urinary tract obstruction
- anal fistula
- metallic implant in the body
- transurethral resection of prostate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrostimulation with exercises MAPsAlso: electrostimulation and exercises of the pelvic floor musclesthis 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 | electrostimulation with exercises MAPs |
| exercises MAPsAlso: exercises of the pelvic floor musclesThis 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 | exercises MAPs |
Primary outcome
urinary incontinence
Time frame: august/2013 to December/2013 (4 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 37070660Johnson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrícia Z Barros, expert principal investigator
Gama Filho University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrostimulation with exercises MAPs and exercises MAPs in people with Urinary Incontinence, run by Universidade Gama Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary incontinence (time frame: august/2013 to December/2013 (4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014; AzTrials last refreshed its copy on 7 Nov 2026.