NCT02620982

ARIES for Vasculogenic Erectile Dysfunction

Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Vasculogenic Erectile Dysfunction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dornier MedTech Systems · Industry
• Sex: Male
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of low-intensity extracorporeal shock wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin.

Detailed description

An increasing number of men are suffering from the effects of Erectile Dysfunction (ED) each year. The development of oral therapies (phosphodiesterase 5 inhibitors) has been successful for many with the disease. However, these drugs may be contraindicated in patients with cardiovascular risk factors (which are often predecessors to developing ED) and are often ineffective in patients with other comorbid conditions, such as diabetes mellitus. The main objective of this study is to determine the safety and efficacy of low-intensity extracorporeal shock wave therapy using the Dornier Aries in the treatment of erectile dysfunction of vasculogenic origin. This protocol allows for treatment of 23 men with 21-75 years of age with vasculogenic erectile dysfunction of at least 6 months' duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries device. This protocol includes the application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J. Conversely, the treatment protocol described within is designed to actually restore penile function as a disease-modifying therapy, and is not expected to require a maintenance regimen or continued treatments, as previous studies have demonstrated retained benefits at six months after the end of treatments. Dornier MedTech hired an independent party to monitor data and perform internal audits to ensure the precision, quality, and integrity of the data collected. The investigator(s) agrees to permit access to study records, source data, and source documents for this purpose.

Conditions

• Erectile Dysfunction
• Sexual Dysfunction, Physiological

Interventions

Type	Name	Description
DEVICE	ARIES (Extracorporal Shock Wave Application)	The treatment protocol includes 1 treatment per week for 6 weeks and an application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-12-03
• Last updated: 2016-09-29

Locations

1 site across 1 country: United States