ARIES for Vasculogenic Erectile Dysfunction

Phase 1

Completed

• Conditions: Erectile Dysfunction; Sexual Dysfunction, Physiological
• Interventions: Device: ARIES (Extracorporal Shock Wave Application)

• Registration Number: NCT02620982
• Lead Sponsor: Dornier MedTech Systems

Brief 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.

Study Timeline

• Study First Submitted: 2015-11-04
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARIES Application	ARIES (Extracorporal Shock Wave Application)	Low intensity Extracorporeal Shockwave Application utilizing the Dornier Aries

Primary Outcome Measures

Name	Time	Method
Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events.	1 month and 3 months	Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events. Higher scores indicate improved functionality according to the minimal clinically important difference (MCID) in erectile function from Rosen et al. 2011.

Secondary Outcome Measures

Name	Time	Method
Changes in penile corporal fibrosis	1 month, 3 months	changes in penile corporal fibrosis as determined by gray scale assessment as measured by duplex ultrasound of the penis during pharmacologic erection will be evaluated and reported
Changing in Erection Hardness score (EHS)	1 month, 3 months	EHS increase in patients with EHS \< 2.
Changes in mean scores of the entire IIEF	1 month, 3 months	Changes in mean scores of the entire IIEF will be evaluated and reported.
Changes in penile base and tip rigidity	3 months	Changes in penile base and tip rigidity as measured by penile plethysmography (Rigiscan) of the penis will be evaluated and reported.
Changes in penile cavernosal artery peak systolic velocity (PSV) in [cm/s] by Penile doppler ultrasonography	3 months	Changes in penile cavernosal artery peak systolic velocity in \[cm/s\] as determined by color measurement of Penile doppler ultrasonography
Changes in mean scores of the SEP	1 month, 3 months	Changes in mean scores of Sexual Encounter Profile (SEP); \[Unit on a Scale\], will be evaluated and reported.
Changes in mean scores of the GAQ	1 month, 3 months	Changes in mean scores of Global Assessment Questionnaire (GAQ); \[Unit on a Scale\], common, will be evaluated and reported.

Trial Locations

Locations (1)

San Diego Sexual Medicine; 🇺🇸 San Diego, California, United States