ARIES for Vasculogenic Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— AriesIDE#1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620982
• Other study ID #: G140216
• Status: Completed
• Phase: Phase 1
• First received: November 4, 2015
• Last updated: September 28, 2016
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Dornier MedTech Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Sexual Dysfunction, Physiological

Intervention

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.

Locations

Country	Name	City	State
United States	San Diego Sexual Medicine	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Dornier MedTech Systems

Country where clinical trial is conducted

United States, 

References & Publications (4)

Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527. Erratum in: JAMA. 2013 May 15;309(19):1994. — View Citation

Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6. — View Citation

Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15. — View Citation

Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014 Oct;21(10):1041-5. doi: 10.1111/iju.12506. Epub 2014 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events.	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.	1 month and 3 months	Yes
Secondary	Changes in penile base and tip rigidity	Changes in penile base and tip rigidity as measured by penile plethysmography (Rigiscan) of the penis will be evaluated and reported.	3 months	No
Secondary	Changes in penile cavernosal artery peak systolic velocity (PSV) in [cm/s] by Penile doppler ultrasonography	Changes in penile cavernosal artery peak systolic velocity in [cm/s] as determined by color measurement of Penile doppler ultrasonography	3 months	No
Secondary	Changes in penile corporal fibrosis	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	1 month, 3 months	No
Secondary	Changing in Erection Hardness score (EHS)	EHS increase in patients with EHS < 2.	1 month, 3 months	No
Secondary	Changes in mean scores of the entire IIEF	Changes in mean scores of the entire IIEF will be evaluated and reported.	1 month, 3 months	No
Secondary	Changes in mean scores of the SEP	Changes in mean scores of Sexual Encounter Profile (SEP); [Unit on a Scale], will be evaluated and reported.	1 month, 3 months	No
Secondary	Changes in mean scores of the GAQ	Changes in mean scores of Global Assessment Questionnaire (GAQ); [Unit on a Scale], common, will be evaluated and reported.	1 month, 3 months	No