Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED

ED is the inability to develop and maintain an erection for satisfactory sexual intercourse
or activity. ED is a highly prevalent medical condition often associated with multiple
causes. It is estimated that more than 50 million American men suffer from mild/moderate to
severe ED. Roughly 50% of men in their 50's, 60% of men in their 60's, and 70% of men in
their 70's suffer from ED. The economic impact of ED is in the billions of dollars. More than
5 billion dollars a year are spent on the pro-erectile medications currently in the market.

Penile vibratory stimulation mimics rapid and repetitive manual/hand stimulation of the
penis. Vibratory stimulation of genitalia is considered safe by the medical community with
important benefits including treatment of orgasmic dysfunction and stress urinary
incontinence. No significant physical or emotional side-effects have been reported in the
medical literature. A recent epidemiological study of the use of vibrators by American women
and men has shown no complaints, and generally high satisfaction and improvement in sexual
response.

Penile erection is controlled by spinal autonomic centers, the activity of which is dependent
on input from supraspinal centers and the genitalia. From a neurophysiological viewpoint,
scientists believe that penile erection is a culmination of multiple successful nerve
reflexes that initiate a vascular event. Simultaneous vibratory stimulation of both surfaces
of the penis at high frequency (70-110 Hz) for 7-10 minutes can lead to gradual filling of
the penis with arterial blood within minutes by activating the pudendo-cavernosal reflex.
Additional physiological effects include progressive rhythmic contraction of the perineal
muscles via the bulbocavernosus reflex, which helps in strengthening rigidity of erection.
This will prepare the user for successful sexual intercourse. Subsequent orgasm and
ejaculation can be very strong and amplified due to stronger contraction of the
bulbospongiosus muscle and activation of higher ejaculatory centers.

This study will assess daily or on-demand ease of use, safety, satisfaction, and efficacy of
the home use of the Food and Drug Administration (FDA) cleared Viberect device by men with
mild to moderate ED

Inclusion Criteria

- mild-moderate erectile dysfunction based on International Index of Erectile Function
(IIEF) erectile function score 13-25

Exclusion Criteria

- Men with neurological disease

- IIEF score less than 13

- Spinal cord injury

- History of priapism

- Pelvic neuropathy

- Post-prostatectomy

- Penile skin lesions or ulcers

- Inability to understand and demonstrate device use instructions