Back to resultsSafety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Primary Purpose
Premature Ejaculation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Functional TENS stimulation
Non-Functional TENS stimulation
Sponsored by
About this trial
This is an interventional device feasibility trial for Premature Ejaculation
Eligibility Criteria
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
Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Functional TENS stimulation
Non-stimulation treatment
Arm Description
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]
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]
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Change in ejaculation latency time
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
Secondary Outcome Measures
Incidence of post-treatment Adverse Events
Post treatment safety evaluation completed by subjects (using safety questionnaire)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177226
Brief Title
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Official Title
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virility Medical Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional TENS stimulation
Arm Type
Experimental
Arm Description
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]
Arm Title
Non-stimulation treatment
Arm Type
Sham Comparator
Arm Description
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]
Intervention Type
Device
Intervention Name(s)
Functional TENS stimulation
Other Intervention Name(s)
1427970 TensMed S82
Intervention Description
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'
Intervention Type
Device
Intervention Name(s)
Non-Functional TENS stimulation
Intervention Description
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'
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Time Frame
Procedure day
Title
Change in ejaculation latency time
Description
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
Time Frame
Procedure day
Secondary Outcome Measure Information:
Title
Incidence of post-treatment Adverse Events
Description
Post treatment safety evaluation completed by subjects (using safety questionnaire)
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire
Description
Self reported - user questionnaire
Time Frame
Procedure day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Gruenwald, MD
Phone
+972-4-777-2819
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Gruenwald, MD
Phone
+972-4-777-2819
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
We'll reach out to this number within 24 hrs