Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study

Study Overview
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Brief Summary
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Erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the United States. The disorder is age-associated. The available treatments include oral therapy, vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin E1, transurethral delivery of alprostadil, Implantation of penile prostheses. The OhhMed Company has developed the Vertica device that provides treatments for improvement of erectile function in patients with erectile dysfunction. This study assess the safety, efficacy, ease of use, and satisfaction of the Vertica device by men with mild to moderate erectile dysfunction.

Official Title
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Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: Vertica RF device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IIEF-EF score of 11-24 with or without the use of medication (PDE5 inhibitors). Erectile dysfunction for at least 3- months Steady relationship for at least 3-months. patient without sensory disorders patient with established organic of erectile dysfunction Exclusion Criteria: investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth) Premature ejaculation Any psychiatric disorder Epilepsy Peyronie 's disease/ penile curvature Coagulopathy Any tumor in the pelvic or penile region within the last 3 years

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vertica<br>Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction | Device: Vertica RF device<br>* The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erectile function (EF) | The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction | Baseline to 1 month post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile dysfunction