Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
NCT ID: NCT03177226
Last Updated: 2017-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2017-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Functional TENS stimulation
Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]
Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Non-stimulation treatment
Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]
Non-Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Interventions
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Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Non-Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical history of premature ejaculation
* Familiar with self- stimulation
* Ability to follow study instructions and complete study assessment tools
* Washout period of two weeks
Exclusion Criteria
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/ lesions
* Any neurological disorder
* Any psychiatric disease and/or any psychiatric medications
* Any neoplastic disease in the past two years
18 Years
60 Years
MALE
No
Sponsors
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Virility Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ilan Gruenwald, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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Rambam Health Care Campus
Haifa, , Israel
Countries
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Central Contacts
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Ilan Gruenwald, MD
Role: CONTACT
Facility Contacts
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Ilan Gruenwald, MD
Role: primary
Other Identifiers
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VM II-Rev-001
Identifier Type: -
Identifier Source: org_study_id
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