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

Study Overview
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Brief Summary
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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.

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

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Device: Functional TENS stimulation
* Device: Non-Functional TENS stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional TENS stimulation<br>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] | Device: Functional TENS stimulation<br>* 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'<br>* Other names: 1427970 TensMed S82;|
| Sham Comparator: Non-stimulation treatment<br>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] | Device: Non-Functional TENS stimulation<br>* 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'<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-treatment Adverse Events | Post treatment safety evaluation completed by subjects (using safety questionnaire) | 72 hours |