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

Not Applicable

• Conditions: Premature Ejaculation
• Interventions: Device: Functional TENS stimulation; Device: Non-Functional TENS stimulation

• Registration Number: NCT03177226
• Lead Sponsor: Virility Medical Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-05-28
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	Procedure day	All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)
Change in ejaculation latency time	Procedure day	The difference between patient ejaculation latency time under perineal functional electrical stimulation during self-stimulation, and latency time during self-stimulation while no electrical stimulation is applied

Secondary Outcome Measures

Name	Time	Method
Incidence of post-treatment Adverse Events	72 hours	Post treatment safety evaluation completed by subjects (using safety questionnaire)

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel