Erectile DysfunctionNCT02284659
Effect of Functional Electrical Stimulation on Erectile Dysfunction
A study testing Functional Electrical Stimulation (FES) in people with Erectile Dysfunction, run by Federal University of Health Science of Porto Alegre.
Trial summary
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction. Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Functional Electrical Stimulation (FES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Mar 2015
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient
- 40 to 65 years of age, with stable marital relationship (6 months)
- Diagnosis of erectile dysfunction (score of less than 22 IIEF5)
- Clinical history of ED for at least 6 months
Who cannot join
- A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)
- Hypogonadism (total testosterone <300 ng / dl)
- Patient reporting use of inhibitors or 5PDE FIC in the last 60 days
- Diagnosis of coronary artery disease and / or cerebrovascular disease
- Impossibility of understanding the goals, technical study and informed consent cognitive impairment
About this study
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
Read the detailed description
Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The application of functional electrical stimulation (FES) has been used due to the high regenerative capacity of smooth muscle cells. This approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration.
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile dysfunction. The men included will be randomized into two groups. The intervention group will conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use FES placebo. Two sessions will be held weekly for four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Functional Electrical Stimulation (FES), FES- Sham
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation (FES)Device
FES (50Hz / 500us)
FES- ShamDevice
| Study group | Role | What they receive |
|---|---|---|
| FES-sham | Sham comparator | Functional Electro Stimulation (FES-sham) Receives: Device: FES- Sham |
| Intervention (FES) | Active comparator | functional electro stimulation Receives: Device: Functional Electrical Stimulation (FES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function with International Index of Erectile Function-5 questionnaire
Measured: 2 times a week for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristiane Carboni, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284659
- Sponsor's protocol ID
- FUHSPortoAlegre
- Status last verified
- Mar 2015
- First submitted
- 31 Oct 2014
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Functional Electrical Stimulation on Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT02284659
- Acronym / sponsor ID
- FUHSPortoAlegre
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Nov 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.
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
Detailed description
Introduction: Erectile dysfunction (ED) affects approximately 150 million men worldwide. The application of functional electrical stimulation (FES) has been used due to the high regenerative capacity of smooth muscle cells. This approach can be beneficial in the treatment of which usually has the ultimate causes cavernous smooth muscle degeneration.
Objective: The aim of this study is to evaluate the FES effect on erectile function in men with erectile dysfunction.
Methods: Randomized Clinical Trial will be selected in which 30 patients with erectile dysfunction. The men included will be randomized into two groups. The intervention group will conduct therapy with FES (50Hz / 500us) for 15 minutes with intensity below the motor threshold and the control group will use FES placebo. Two sessions will be held weekly for four weeks. Erectile function will be assessed using the validated questionnaire IIEF-5. The instrument will be completed by blinded researcher and the technique is randomized and the treatment done randomly.
Expected Results: The hypothesis is that treatment with FES decrease erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES-sham | Sham comparator | Device: FES- ShamFunctional Electro Stimulation (FES-sham) |
| Intervention (FES) | Active comparator | Device: Functional Electrical Stimulation (FES)functional electro stimulation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patient
- 40 to 65 years of age, with stable marital relationship (6 months)
- Diagnosis of erectile dysfunction (score of less than 22 IIEF5)
- Clinical history of ED for at least 6 months
Key exclusion criteria (5 listed)
- A neurogenic (spinal cord injury, Parkinson's, MS, post prostatectomy)
- Hypogonadism (total testosterone <300 ng / dl)
- Patient reporting use of inhibitors or 5PDE FIC in the last 60 days
- Diagnosis of coronary artery disease and / or cerebrovascular disease
- Impossibility of understanding the goals, technical study and informed consent cognitive impairment
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 |
|---|---|---|
| Functional Electrical Stimulation (FES)FES (50Hz / 500us) | Device | Intervention (FES) |
| FES- Sham | Device | FES-sham |
Primary outcome
Erectile function with International Index of Erectile Function-5 questionnaire
Time frame: 2 times a week for 30 minutes
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 6 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) in people with Erectile Dysfunction, run by Federal University of Health Science of Porto Alegre.
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 5 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Erectile function with International Index of Erectile Function-5 questionnaire (time frame: 2 times a week for 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.