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Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of new blood vessels. The investigators hypothesized that LISW therapy could improve the symptoms of patients with erectile dysfunction resulting from a problem of blood supply that do not respond to oral therapy (PDE-5 inhibitors).
In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Sham Comparator | We use the same probe that induces the same sensation on the penis and the same noise yet no energy |
|
| Shock wave therapy | Active Comparator | 12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shockwave Therapy Generator (Vascuspec) | Device | Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites. |
| Measure | Description | Time Frame |
|---|---|---|
| IIEF-ED Domain | A change of 5 points or more will indicate success | 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rigidity score | a scale of 3 and above indicates success | 17 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoram Vardi, Prof | Contact | ++97248542819 | yvardi@rambam.health.gov.il | |
| Ilan Gruenwald, MD | Contact | ++97248542819 | i_gruenwald@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Yoram Vardi, prof | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | Israel | 31096 | Israel |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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|
| Low intensity shock wave therapy | Device | Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites. |
|
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |