- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363918
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90540040
- Mundo do Assoalho Pélvico
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: intervention (IG1)
|
bioelectric stimulation
|
Active Comparator: intervention (MyoStim group)
|
bioelectric stimulation
|
Sham Comparator: control (CG)
|
bioelectric stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
8 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Alexandre Fornari, PhD, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3.076.079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionCzech Republic, Lithuania, Netherlands, Palestinian Territories, Occupied
-
Rexahn Pharmaceuticals, Inc.CompletedErectile Dysfunction (ED)United States
-
SK Chemicals Co., Ltd.TerminatedMale Erectile Dysfunction
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
Clinical Trials on bioelectric stimulation
-
Federal University of Health Science of Porto AlegreIrmandade Santa Casa de Misericórdia de Porto Alegre; Leonhardt Ventures LLCNot yet recruitingRenal Insufficiency, Chronic | Electric Stimulation
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | Adult Acute Myeloid Leukemia With Del(5q) | Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Untreated Adult Acute Myeloid... and other conditionsUnited States
-
Brooke Army Medical CenterUnknownAnger | Irritability | Combat Related SymptomsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung CancerUnited States
-
AdventHealthRecruitingSurgical Site InfectionUnited States
-
St. Joseph's Healthcare HamiltonMcMaster UniversityCompleted
-
Ohio State University Comprehensive Cancer CenterNot yet recruitingMalignant Solid Neoplasm | Lymphedema | Hematopoietic and Lymphoid System NeoplasmUnited States
-
Eastern Virginia Medical SchoolNational Cancer Institute (NCI); National Institute of General Medical Sciences...UnknownMelanoma (Skin) | Non-melanomatous Skin CancerUnited States
-
Cairo UniversityNot yet recruiting
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedLymphedema | Perioperative/Postoperative Complications | Stage II Vulvar Cancer AJCC v7 | Stage IIIA Vulvar Cancer AJCC v7 | Stage IIIB Vulvar Cancer AJCC v7 | Stage IIIC Vulvar Cancer AJCC v7 | Stage IVA Vulvar Cancer AJCC v7 | Stage IA Vulvar Cancer AJCC v7 | Stage IB Vulvar Cancer AJCC v7 | Stage IVB...United States