ARIES for Vasculogenic Erectile Dysfunction (AriesIDE#1)

Dornier MedTech

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction; Sexual Dysfunction, Physiological

Treatments: Device: ARIES (Extracorporal Shock Wave Application)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02620982

G140216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Male

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 21 - 75 years
• Presence of Erectile Dysfunction for at least 6 months
• Having some response to a PDE5i or injection therapy (ICI) without penile scarring
• Vasculogenic ED
• IIEF-ED score ≥11 up to ≤25 while taking PDE5i or on ICI
• In a stable heterosexual relationship of more than three months' duration
• Agree to suspend all ED therapy for duration of study
• Agree to maintain their normal sexual habits
• Consent to participate

Exclusion criteria

• Radical prostatectomy
• Previous radiation therapy to pelvis
• Previous stem cell or platelet rich plasma therapy
• Previous pelvic surgeries
• Untreated Hypogonadism or thyroid disease
• Hormone usage, other than testosterone, clomiphene or thyroid medication
• Illicit drug usage as demonstrated in the drug screen
• Psychogenic ED
• Peyronie's Disease or penile curvature that negatively influences sexual activity
• Current anticoagulation therapy or significant hematological conditions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

ARIES Application

Experimental group

Description:

Low intensity Extracorporeal Shockwave Application utilizing the Dornier Aries

Treatment:

Device: ARIES (Extracorporal Shock Wave Application)