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

NCT04484090 | Completed

• 1 other identifier: OHH-FE-0.1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vertica

EXPERIMENTAL

Treatment with Vertica RF device for improving erectile function for men with erectile dysfunction

Device: Vertica RF device

Interventions

Vertica RF device DEVICE

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

Vertica

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: The OhhMed device provide treatments for improvement of erectile dysfunction
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHH-MED Medical Ltd: lead

Study Sites (1)

Rambam Medical center

Haifa, 3525408, Israel

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Ilan Gruenwald, Prof.

  Rambam Medical Center, Haifa Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: January 20, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)