Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

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.

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Device: TENS Stimulator

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS stimulator; Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)	Device: TENS Stimulator; Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle; Other Names: TensMed S82 ENRAF-NONIUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-treatment Adverse Events	Post treatment safety evaluation completed by subjects (using safety questionnaire)	72 hours

Collaborators and Investigators

• Sponsor: Virility Medical Ltd.
• Investigators: Principal Investigator: Ilan Gruenwald, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Premature Ejaculation
• Other Study ID Numbers: VM-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