Erectile Dysfunction Clinical Trial
Official title:
The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction: a Randomized Controlled Trial
Verified date | April 2020 |
Source | Federal University of Health Science of Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Mundo do Assoalho Pélvico | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 8 weeks |
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