Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Safety and Efficacy Assessment of the VERTICA® - a Radio Frequency Device for the Treatment of Erectile Dysfunction

Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.

Inclusion Criteria:

• Adult, heterosexual, males between 22 and 85 years of age
• Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
• Subjects with an IIEF-EF score between 11-21
• Steady relationship for at least 3 months
• Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month
• Subject is willing to sign informed consent and follow study protocol procedures
• Subject has a smartphone

Exclusion Criteria:

• Castrate and late onset hypogonadism
• History of Priapism or Peyronie's Disease
• Surgery or radiotherapy of the pelvic region
• Anatomic penile deformations or penile prosthesis
• Treatment with antiandrogens
• Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
• History of urothelial or colorectal cancer
• Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
• Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
• Subjects who are taking anticoagulation or anti-platelet therapy
• History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
• Subjects who are incarcerated
• Subjects who are cognitively challenged
• Serious heart or lung disease
• Pregnant partner