Erectile DysfunctionNCT04363918
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction
A study testing bioelectric stimulation in people with Erectile Dysfunction, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
Erectile dysfunction (ED), as defined by the International Consultation on Sexual Medicine, is the consistent and recurrent inability to acquire or sustain an erection of sufficient rigidity and duration to engage in satisfactory sexual intercourse. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- bioelectric stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2019to 1 Nov 2019
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men with known ED (defined as a score of less than 22 on the IIEF-5)
- who had been in a stable relationship for more than 6 months
- not taking any ED medication.
Who cannot join
- neurogenic ED (due to spinal cord injury, Parkinson's disease, multiple sclerosis, prostatectomy)
- hypogonadism (total testosterone < 300 ng/ dl)
- decompensated diabetes mellitus (fasting blood glucose > 200 mg/dl and/or glycated hemoglobin > 8%)
- decompensated systemic arterial hypertension (SBP > 160 and/or DBP > 100)
- morbid obesity
- diagnosis of coronary heart disease and/or cerebrovascular disease
- inability to understand the study objectives/technique or to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Mundo do Assoalho Pélvico
Porto Alegre, Rio Grande do Sul, 90540040
About this study
Official title: The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction: a Randomized Controlled Trial
Erectile dysfunction (ED), as defined by the International Consultation on Sexual Medicine, is the consistent and recurrent inability to acquire or sustain an erection of sufficient rigidity and duration to engage in satisfactory sexual intercourse. In the search for other approaches to treat ED the use of bioelectrical stimulation (BES) has been successfully introduced and applied in clinical studies. In the search for other approaches to treat ED the use of bioelectrical stimulation (BES) has been successfully introduced and applied in clinical studies.
Read the detailed description
The investigators randomized 30 male patients, aged 40 to 75 years, with known ED (defined as a score of less than 22 on the IIEF-5), who had been in a stable relationship for more than 6 months and not taking any ED medication.
Participants were randomly assigned to three groups: intervention (IG1), intervention (MyoStim group) or control (CG). The IG1 received FES therapy (50 Hz/500 μs) for a total of 4 weeks, divided into two weekly sessions lasting 15 minutes each, with intensity set lower than the motor threshold that was assessed individually. The MyoStim group received a combination of low frequency BES and microcurrente for a total of 4 weeks, divided in two weekly sessions lasting 45 minutes each with intensity set lower than the motor threshold that was assessed individually which was delivered via two patch electrodes placed on the dorsum surface of the penis and connected to a desk top Mettler model 240 Bioelectric Stimulator, which was adjusted to reach each of the signals included in the protocol. In all three groups two self-adhesive electrodes measuring 3 cm each were used. One electrode was placed at the base of the penis, while the second was attached 2 cm below the first one. The control group was treated with placebo FES machine (the red light functioning but there was no power). Both groups attended sessions twice a week for a period of 4 weeks, for a total of 8 FES sessions. Erectile function was assessed by the validated International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS) instruments. All of the questionnaires were applied before and immediately after the treatment. The instruments were completed by a blinded investigator, according to the protocol to which the patient had been randomized. Only the physiotherapist who applied the technique was aware of group allocation. Participants had no treatment costs.
The IG1 received actual stimulation for only the VEGF signal during the each treatment period, while the multi-signal MyoStim group received actual stimulation at precise frequencies for the five proteins which were changed every 5-15 minutes including.
All subjects completed all 8 treatments and the study questionnaires and metrics of ED before and at the end of the study. The study was unblinded when the last enrolled patient had completed their 4 weeks of treatment. The study included an opportunity for all patients randomized to the Control group to then receive the full four-week, 8 session treatment, for whichever of the two active treatment arms, VEGF alone or Myostim, was shown to be most effective. MyoStim treatment was clearly superior to the other treatment arms and all ten Control subjects elected to complete the full 4-week treatment with the MyoStim protocol in an open-label cross-over design. These ten subjects were then added to the original cohort assigned to MyoStim, for a total of 20 patients in the MyoStim arm. The statistical analysis was completed for the original treatment assignments with 10 subjects in each group and the total of 20 MyoStim subjects versus VEGF alone or Control.
- Conditions
- Erectile Dysfunction
- Being tested
- bioelectric stimulation
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioelectric stimulationDevice
bioelectric stimulation
| Study group | Role | What they receive |
|---|---|---|
| intervention (IG1) | Active comparator | Not described Receives: Device: bioelectric stimulation |
| intervention (MyoStim group) | Active comparator | Not described Receives: Device: bioelectric stimulation |
| control (CG) | Sham comparator | Not described Receives: Device: bioelectric stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile function
Erectile Function With International Index of Erectile Function-5 Questionnaire: The IIEF-5 questionnaire score determined the presence and severity of ED: absent (> 21), mild (17-21), mild / moderate (12-16), moderate (8-11) and severe (<8)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start1 Mar 2019
- Primary completion1 Jun 2019
- Study completion1 Nov 2019
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- Investigators
- Alexandre Fornari, PhD, Study chair, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363918
- Sponsor's protocol ID
- 3.076.079
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04363918
- Acronym / sponsor ID
- 3.076.079
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 27 Apr 2020 (actual)
- 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.
Erectile dysfunction (ED), as defined by the International Consultation on Sexual Medicine, is the consistent and recurrent inability to acquire or sustain an erection of sufficient rigidity and duration to engage in satisfactory sexual intercourse. In the search for other approaches to treat ED the use of bioelectrical stimulation (BES) has been successfully introduced and applied in clinical studies. In the search for other approaches to treat ED the use of bioelectrical stimulation (BES) has been successfully introduced and applied in clinical studies.
Detailed description
The investigators randomized 30 male patients, aged 40 to 75 years, with known ED (defined as a score of less than 22 on the IIEF-5), who had been in a stable relationship for more than 6 months and not taking any ED medication.
Participants were randomly assigned to three groups: intervention (IG1), intervention (MyoStim group) or control (CG). The IG1 received FES therapy (50 Hz/500 μs) for a total of 4 weeks, divided into two weekly sessions lasting 15 minutes each, with intensity set lower than the motor threshold that was assessed individually. The MyoStim group received a combination of low frequency BES and microcurrente for a total of 4 weeks, divided in two weekly sessions lasting 45 minutes each with intensity set lower than the motor threshold that was assessed individually which was delivered via two patch electrodes placed on the dorsum surface of the penis and connected to a desk top Mettler model 240 Bioelectric Stimulator, which was adjusted to reach each of the signals included in the protocol. In all three groups two self-adhesive electrodes measuring 3 cm each were used. One electrode was placed at the base of the penis, while the second was attached 2 cm below the first one. The control group was treated with placebo FES machine (the red light functioning but there was no power). Both groups attended sessions twice a week for a period of 4 weeks, for a total of 8 FES sessions. Erectile function was assessed by the validated International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS) instruments. All of the questionnaires were applied before and immediately after the treatment. The instruments were completed by a blinded investigator, according to the protocol to which the patient had been randomized. Only the physiotherapist who applied the technique was aware of group allocation. Participants had no treatment costs.
The IG1 received actual stimulation for only the VEGF signal during the each treatment period, while the multi-signal MyoStim group received actual stimulation at precise frequencies for the five proteins which were changed every 5-15 minutes including.
All subjects completed all 8 treatments and the study questionnaires and metrics of ED before and at the end of the study. The study was unblinded when the last enrolled patient had completed their 4 weeks of treatment. The study included an opportunity for all patients randomized to the Control group to then receive the full four-week, 8 session treatment, for whichever of the two active treatment arms, VEGF alone or Myostim, was shown to be most effective. MyoStim treatment was clearly superior to the other treatment arms and all ten Control subjects elected to complete the full 4-week treatment with the MyoStim protocol in an open-label cross-over design. These ten subjects were then added to the original cohort assigned to MyoStim, for a total of 20 patients in the MyoStim arm. The statistical analysis was completed for the original treatment assignments with 10 subjects in each group and the total of 20 MyoStim subjects versus VEGF alone or Control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention (IG1) | Active comparator | Device: bioelectric stimulation |
| intervention (MyoStim group) | Active comparator | Device: bioelectric stimulation |
| control (CG) | Sham comparator | Device: bioelectric stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men with known ED (defined as a score of less than 22 on the IIEF-5)
- who had been in a stable relationship for more than 6 months
- not taking any ED medication.
Key exclusion criteria (7 listed)
- neurogenic ED (due to spinal cord injury, Parkinson's disease, multiple sclerosis, prostatectomy)
- hypogonadism (total testosterone < 300 ng/ dl)
- decompensated diabetes mellitus (fasting blood glucose > 200 mg/dl and/or glycated hemoglobin > 8%)
- decompensated systemic arterial hypertension (SBP > 160 and/or DBP > 100)
- morbid obesity
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 |
|---|---|---|
| bioelectric stimulationbioelectric stimulation | Device | control (CG), intervention (IG1), intervention (MyoStim group) |
Primary outcome
Erectile function
Time frame: 8 weeks
Erectile Function With International Index of Erectile Function-5 Questionnaire: The IIEF-5 questionnaire score determined the presence and severity of ED: absent (> 21), mild (17-21), mild / moderate (12-16), moderate (8-11) and severe (<8)
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 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
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.
Alexandre Fornari, PhD study chair
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioelectric stimulation in people with Erectile Dysfunction, run by Federal University of Health Science of Porto Alegre 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 3 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 Apr 2020. 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. 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 (time frame: 8 weeks). 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 27 Apr 2020.