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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Medical center

Haifa, 3525408, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vertica RF device

Device

The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction

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

Sponsors and collaborators

Lead sponsor

OHH-MED Medical Ltd

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jul 23, 2020
Registry last updated: Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed