Extracorporeal Shock Wave Therapy for the Treatment of Erectile Dysfunction

Medispec

Status and phase

Completed

Phase 2

Phase 1

Conditions

Erectile Dysfunction

Treatments

Device: Extracorporeal Shockwave Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00901056

ED-ESWT

Details and patient eligibility

About

Low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones.

The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to PDE-5 inhibitors.

Full description

Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.

Enrollment

20 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ED of more than 6 months
At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
Positive response to PDE-5 inhibitors
IIEF-5 domain score of 12-20 denoting mild to severe ED
Non-Neurological pathology
Stable heterosexual relationship for more than 3 months

Exclusion criteria

NPT - normal/flat
Prior prostatectomy surgery
Any cause of ED other than vascular related
Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
Clinically significant chronic hematological disease
Cardiovascular conditions that prevent sexual activity
History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
Cancer within the past 5 years.
Anti-androgens, oral or injectable androgens
Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories