Erectile Dysfunction
Conditions
Keywords
ED, Erectile Dysfunction, Erectile dysfunction treated with PDE-5 inhibitors
Brief summary
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.
Detailed 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.
Interventions
DEVICEExtracorporeal Shockwave Therapy
Energy Density - 0.02 - 0.15 mJ/mm2
Sponsors
Rambam Health Care Campus
Medispec
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IIEF score | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Rigid Score (RS) | 3 months |
| Quality of Erection Questionnaire (QEQ) | 3 months |
| Self-Esteem And Relationship Questionnaire (SEAR) | 3 months |
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDIT) | 3 months |
| Side Effects | 3 months |
Countries
Israel
Outcome results
None listed