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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484090
• Other study ID #: OHH-FE-0.1
• Status: Completed
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: January 2023
• Source: OHH-MED Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Israel	Rambam Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
OHH-MED Medical Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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