The Use of Bioelectrical Stimulation in the Treatment of Erectile Dysfunction
1 other identifier
interventional
30
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 27, 2020
CompletedApril 27, 2020
April 1, 2020
3 months
April 21, 2020
April 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
intervention (IG1)
ACTIVE COMPARATORintervention (MyoStim group)
ACTIVE COMPARATORcontrol (CG)
SHAM COMPARATORInterventions
bioelectric stimulation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mundo do Assoalho Pélvico
Porto Alegre, Rio Grande do Sul, 90540040, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexandre Fornari, PhD
Federal University of Health Science of Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 27, 2020
Study Start
March 1, 2019
Primary Completion
June 1, 2019
Study Completion
November 1, 2019
Last Updated
April 27, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share