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ARIES for Vasculogenic Erectile Dysfunction (AriesIDE#1)

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ClinicalTrials.gov Identifier: NCT02620982
Recruitment Status : Completed
First Posted : December 3, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Dornier MedTech Systems

Study Description
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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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Sexual Dysfunction, Physiological Device: ARIES (Extracorporal Shock Wave Application) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-Intensity Extracorporeal Shock Wave Therapy for the Treatment of Vasculogenic Erectile Dysfunction
Study Start Date : December 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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

  4. Changing in Erection Hardness score (EHS) [ Time Frame: 1 month, 3 months ]
    EHS increase in patients with EHS < 2.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620982


Locations
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United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120
Sponsors and Collaborators
Dornier MedTech Systems
Investigators
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Principal Investigator: Irwin Goldstein, M. D. San Diego Sexual Medicine
More Information
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Publications:

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Responsible Party: Dornier MedTech Systems
ClinicalTrials.gov Identifier: NCT02620982    
Other Study ID Numbers: G140216
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Keywords provided by Dornier MedTech Systems:
Shockwave
vascular ED
Organic ED
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders