ARIES for Vasculogenic Erectile Dysfunction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Erectile Dysfunction |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | July 2016 |
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.
wave therapy utilizing the Dornier Aries in the treatment of erectile dysfunction of
vasculogenic origin.
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.
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.
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
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