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

Premature Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177226
• Other study ID #: VM II-Rev-001
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2017
• Last updated: June 1, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Virility Medical Ltd.
• Contact: Ilan Gruenwald, MD
• Phone: +972-4-777-2819
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Device:
• Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
• Non-Functional TENS stimulation
A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Virility Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire	Self reported - user questionnaire	Procedure day
Primary	Incidence of Treatment-Emergent Adverse Events	All Self reported safety events (e.g. discomfort, pain, local irritation, local heat, noticeable changes in urination or bowl activity or any other complaint)	Procedure day
Primary	Change in ejaculation latency time	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	Procedure day
Secondary	Incidence of post-treatment Adverse Events	Post treatment safety evaluation completed by subjects (using safety questionnaire)	72 hours