Safety and Efficacy of Ohhmed Treatments for the Improvement of Erectile Dysfunction - A Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- OHH-MED Medical Ltd
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Change in erectile function (EF)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •Peyronie 's disease/ penile curvature
- •Coagulopathy
- •Any tumor in the pelvic or penile region within the last 3 years
Outcomes
Primary Outcomes
Change in erectile function (EF)
Time Frame: Baseline to 1 month post intervention
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