Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)

Stopped early · Not applicable · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

This protocol allows for treatment of 100 men in two groups (placebo and active treatment) of 22-70 years of age with mild (IIEF EF of 17 to 25 at baseline) vasculogenic erectile dysfunction of at least 6 months duration with low intensity extracorporeal shock wave therapy utilizing the Dornier Aries 2 device.

Key facts

Study ID

NCT03039218

Run by

Dornier MedTech Systems

People needed

54

Starts

2017-02-07

Expected to finish

2018-03-29

Last updated by the study team

2018-08-17

Who can join

Age: 22 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Consent to participate.
• Age 22-70 years.
• Presence of Vasculogenic Erectile Dysfunction for at least 6 months.
• Having some response to a PDE5i. Last PDE5i use must be within 30 days of Screening Visit.
• IIEF-EF score ≥17 up to ≤30 while taking PDE5i.
• IIEF-EF score ≥17 up to ≤25 after wash out of PDE5i.
• In a stable heterosexual relationship of more than three months duration.
• Sexually active and agree to suspend all ED therapy for duration of study.
• Agree to maintain their normal sexual habits.

You may not qualify if…

• Radical prostatectomy.
• Previous radiation therapy to pelvis.
• Previous stem cell or platelet rich plasma therapy.
• Previous pelvic surgeries that in the judgment of the investigator could impact on erectile function such as radical prostatectomy, radical cystectomy, Peyronie's disease surgery, penile lengthening or penile cancer surgery.
• Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
• Hormone usage, other than testosterone, clomiphene or thyroid medication.
• Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine 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 as demonstrated in abnormal values in the complete blood count.
• Liver disease as demonstrated by abnormal chemistry panel or coagulation values in the prothrombin time (PT) along with its derived measures of prothrombin ratio (PR) blood tests.
• Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
• Patients with cardiac or non-cardiac electrical devices implanted.
• Anatomical or neurological abnormalities in the treatment area.
• Diabetes Mellitus with severe polyneuropathy.
• Patients with generalized polyneuropathy irrespective of cause.
• Refusal to suspend ED therapy for duration of study.
• Men deemed not healthy enough to participate in sexual activity.
• IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
• Average EHS ≤ 2 at baseline assessment following "washout".
• Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
• Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
• Known allergy to ultrasound gel.

Where it is running

• San Diego Sexual Medicine — San Diego, California, United States
• Adult Pediatric Urology & Urogynecology — Omaha, Nebraska, United States
• Brooklyn Urology Research Group — Brooklyn, New York, United States
• Manhattan Medical Research — New York, New York, United States

Full record on ClinicalTrials.gov

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