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

Virility Medical

Status: Completed

Conditions: Premature Ejaculation

Treatments: Device: TENS Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03174470

VM-Rev-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TENS stimulator

Experimental group

Description:

Single day Transcutaneous electrical nerve stimulations utilizing a commercial TENS stimulator (TensMed S82 ENRAF-NONIUS)

Treatment:

Device: TENS Stimulator