Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation

Virility Medical

Status: Unknown

Conditions: Premature Ejaculation

Treatments: Device: Non-Functional TENS stimulation; Device: Functional TENS stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03177226

VM II-Rev-001

Details and patient eligibility

About

Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good general health
• Clinical history of premature ejaculation
• Familiar with self- stimulation
• Ability to follow study instructions and complete study assessment tools
• Washout period of two weeks

Exclusion criteria

• History of cardio-vascular 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 any psychiatric medications
• Any neoplastic disease in the past two years

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Functional TENS stimulation

Experimental group

Description:

Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]

Treatment:

Device: Functional TENS stimulation

Non-stimulation treatment

Sham Comparator group

Description:

Short stimulation to identifying Sensory Threshold and Motor Threshold, followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase \[from full erection to ejaculation\]

Treatment:

Device: Non-Functional TENS stimulation