- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03177226
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
June 1, 2017 updated by: Virility Medical Ltd.
Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ilan Gruenwald, MD
- Phone Number: +972-4-777-2819
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Rambam Health Care Campus
-
Contact:
- Ilan Gruenwald, MD
- Phone Number: +972-4-777-2819
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Good general health
- 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:
- History of cardio-vascular disorders
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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]
|
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'
Other Names:
|
Sham Comparator: 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]
|
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'
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Time Frame: Procedure day
|
All Self reported safety events (e.g.
discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
|
Procedure day
|
Change in ejaculation latency time
Time Frame: Procedure day
|
The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied
|
Procedure day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of post-treatment Adverse Events
Time Frame: 72 hours
|
Post treatment safety evaluation completed by subjects (using safety questionnaire)
|
72 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire
Time Frame: Procedure day
|
Self reported - user questionnaire
|
Procedure day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ilan Gruenwald, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
May 28, 2017
First Submitted That Met QC Criteria
June 1, 2017
First Posted (Actual)
June 6, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VM II-Rev-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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