Premature Ejaculation
Conditions
Brief summary
The company suggests a new concept of treatment for PE: Transient inhibition of striated muscle contraction by a transcutaneous stimulation device. This study aim is to evaluate the safety of delivering increasing electrical stimulation intensities to the subject's perineum, using a TENS technique and equipment, followed by a 72-hour postoperative follow-up.
Interventions
DEVICETENS Stimulator
Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
Sponsors
Virility Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy * Ability to follow study instructions and complete study assessment tools
Exclusion criteria
* History of cardiovascular 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 psychiatric medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Baseline | Pain sensation score given by all subjects, as well as their verbal description of what they sensed during the various stimulations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-treatment Adverse Events | 72 hours | Post treatment safety evaluation completed by subjects (using safety questionnaire) |
Countries
Israel
Outcome results
None listed