Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ejaculation
- Sponsor
- Virility Medical Ltd.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: 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
Time Frame: 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 Outcomes
- Incidence of post-treatment Adverse Events(72 hours)