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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 through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment LI-ESWT | Experimental | Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity shock waves | Device | 1500 shocks, Energy Density - 0.09 mJ/mm2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rigidity Score Questionaire- an increase by at least 1 point is considered success | 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Gruenwald, MD | Contact | 00972-4-8542882 | i_gruenwald@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ilan Gruenwald, MD | Rambam Health Care Campus | Principal Investigator |
| Yoram Vardi, Prof. | Rambam Health Care Campus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Medical Center | Recruiting | Haifa | 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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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |