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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Device: Vertica RF device

• Registration Number: NCT04484090
• Lead Sponsor: OHH-MED Medical Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-20
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Primary Completion: 2021-09-20
• Study Completion: 2021-09-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vertica	Vertica RF device	Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction

Primary Outcome Measures

Name	Time	Method
Change in erectile function (EF)	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

Trial Locations

Locations (1)

Rambam Medical center; 🇮🇱 Haifa, Israel