ARIES for Vasculogenic Erectile Dysfunction

NCT02620982 | Completed Phase 1 DMC

• 1 other identifier: G140216
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Keywords

Shockwave; vascular ED; Organic ED

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Changes in penile base and tip rigidity

  3 months

• Changes in penile cavernosal artery peak systolic velocity (PSV) in [cm/s] by Penile doppler ultrasonography

  3 months

• Changes in penile corporal fibrosis

  1 month, 3 months

• Changing in Erection Hardness score (EHS)

  1 month, 3 months

• Changes in mean scores of the entire IIEF

  1 month, 3 months

Study Arms (1)

ARIES Application

EXPERIMENTAL

Low intensity Extracorporeal Shockwave Application utilizing the Dornier Aries

Device: ARIES (Extracorporal Shock Wave Application)

Interventions

ARIES (Extracorporal Shock Wave Application) DEVICE

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.

ARIES Application

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dornier MedTech Systems: lead

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Publications (4)

• 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.

  PMID: 20451317 BACKGROUND

• 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.

  PMID: 22425129 BACKGROUND

• 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.

  PMID: 24942563 BACKGROUND

• 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.

  PMID: 23592107 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

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

Study Officials

• Irwin Goldstein, M. D.

  San Diego Sexual Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: December 3, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)