Premature Ejaculation
Conditions
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.
Interventions
DEVICEFunctional 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'
DEVICENon-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'
Sponsors
Virility Medical Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-treatment Adverse Events | 72 hours | Post treatment safety evaluation completed by subjects (using safety questionnaire) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effects of applied electrical stimulation on Erection using Self Reported - User Questionnaire | Procedure day | Self reported - user questionnaire |
Countries
Israel
Contacts
Primary ContactIlan Gruenwald, MD
Outcome results
None listed