ARIES for Vasculogenic Erectile Dysfunction (AriesIDE#1)

September 28, 2016 updated by: Dornier MedTech Systems

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • San Diego Sexual Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARIES Application
Low intensity Extracorporeal Shockwave Application utilizing the Dornier Aries
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the mean of the International Index of Erectile Function ED Domain ("IIEF-ED") scores, in the absence of severe adverse events.
Time Frame: 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.
1 month and 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dornier MedTech Systems

Investigators

  • Principal Investigator: Irwin Goldstein, M. D., San Diego Sexual Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G140216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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