Back to resultsSafety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TENS Stimulator
Sponsored by
About this trial
This is an interventional device feasibility trial for Premature Ejaculation
Eligibility Criteria
Inclusion Criteria:
- Generally healthy
- Ability to follow study instructions and complete study assessment tools
Exclusion Criteria:
- History of cardiovascular 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 psychiatric medications
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TENS stimulator
Arm Description
Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)
Outcomes
Primary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations
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
NCT03174470
Brief Title
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Official Title
Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
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
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS stimulator
Arm Type
Experimental
Arm Description
Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)
Intervention Type
Device
Intervention Name(s)
TENS Stimulator
Other Intervention Name(s)
TensMed S82 ENRAF-NONIUS
Intervention Description
Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations
Time Frame
Baseline
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Generally healthy
Ability to follow study instructions and complete study assessment tools
Exclusion Criteria:
History of cardiovascular 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 psychiatric medications
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
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