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

Virility Medical Ltd.20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Premature Ejaculation

Interventions

TENS StimulatorDEVICE

Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rambam Health Care Campus

Haifa, Israel

Outcomes

Primary Outcomes

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

Time frame: Baseline

Secondary Outcomes

Incidence of post-treatment Adverse Events

Post treatment safety evaluation completed by subjects (using safety questionnaire)

Time frame: 72 hours

Data from ClinicalTrials.gov

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