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

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.

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