Safety and Efficacy Assessment of the VERTICA® - A Device to Treat Erectile Dysfunction

UCI Specialty Area: Urology

Principal Investigator: Faysal Yafi

Official Title: Safety and Efficacy Assessment of the VERTICA® - A Radio Frequency Device for the Treatment of Erectile Dysfunction (ED).

A Study On:

Urology

Study Description

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.

Eligibility

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

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

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

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