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

A Randomized, Double-Blind, Placebo-Controlled, Open-Label Extension Clinical Trial of the Dornier Aries 2 Extracorporeal Shock Wave Device for the Treatment of Mild Erectile Dysfunction (ED)

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.

This trial is a prospective, randomized, placebo-controlled, double-blind pivotal study, with an open-label extension. The study will include 4 sites and multiple investigators. A total of 100 men with at least a 6-month history of ED and who have responded to PDE5 inhibitors will be enrolled. The trial comprises two arms to achieve equal characteristics, where patients are randomly assigned to active treatment or sham treatment.

All patients on active treatment will receive LI-ESWT treatment using the Dornier Aries 2. Patients assigned to the placebo group will receive the Dornier Aries 2 treatment using a sham applicator. The time between two treatments is 6-7 days to allow for angiogenesis and perfusion improvements to occur. The subjects' duration of participation will be a total of 34 weeks Subjects will also be asked to maintain their current level of sexual activity while participating in the study.

Inclusion Criteria:

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

Exclusion Criteria:

1. Radical prostatectomy.
2. Previous radiation therapy to pelvis.
3. Previous stem cell or platelet rich plasma therapy.
4. 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.
5. Untreated Hypogonadism as demonstrated by abnormal testosterone levels lower than 300 ng/dL.
6. Hormone usage, other than testosterone, clomiphene or thyroid medication.
7. Use of cocaine, cannabinoids, opiates, barbiturates, amphetamines, or benzodiazepine as demonstrated in the drug screen.
8. Psychogenic ED.
9. Peyronie's Disease or penile curvature that negatively influences sexual activity.
10. Current anticoagulation therapy or significant hematological conditions as demonstrated in abnormal values in the complete blood count.
11. 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.
12. Abnormal serum testosterone level defined as a value lower than 300 ng/dL or greater than 1197 ng/dL.
13. Patients with cardiac or non-cardiac electrical devices implanted.
14. Anatomical or neurological abnormalities in the treatment area.
15. Diabetes Mellitus with severe polyneuropathy.
16. Patients with generalized polyneuropathy irrespective of cause.
17. Refusal to suspend ED therapy for duration of study.
18. Men deemed not healthy enough to participate in sexual activity.
19. IIEF-EF score of 0-16 or higher than 25 at baseline assessment following "washout" period.
20. Average EHS ≤ 2 at baseline assessment following "washout".
21. Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
22. 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.
23. Known allergy to ultrasound gel.