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| Name | Class |
|---|---|
| Medispec | INDUSTRY |
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This study aims to evaluate the effect of shockwave therapy on erectile dysfunction on patients responding to PDE5i therapy in a sham controlled randomized double blind manner.
This study aims to evaluate the effect of a 12-session low intensity shockwave therapy protocol for patients with erectile dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shock wave treatment | Active Comparator |
| |
| "MEDISPEC" Sham | Sham Comparator | "MEDISPEC" Probe does not deliver energy but creates same noise and sensation of active probe |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "MEDISPEC" treatment probe | Device | 300 shocks in 5 different anatomical locations of the penis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile function- Erectile Function Domain | An increase in score of 5points and above will be considered success. | At screening and 17 weeks later at last visit |
| Measure | Description | Time Frame |
|---|---|---|
| Rigidity scale | A change from 1,2 to a result of 3 or 4 of the rigidity scale points will be considered success | At screening and 17 weeks later at last visit |
| Flow Mediated Dilatation Technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | Israel | 31096 | Israel |
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| "MEDISPEC" Sham Probe | Device | Sham probe applied same as treatment probe without energy |
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| "MEDISPEC" Low intensity shock waves | Device | Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min |
|
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| Sham | Device | Probe does not deliver energy but creates same noise and sensation of active probe |
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A specialized sphygmomanometer cuff located at the penile base, is inflated to 50 mm Hg for 5min to induce a venous filling. A mercury strain gauge is placed at least 1-2 cm above the penile cuff. Baseline penile blood flow is obtained. Postischemic penile blood flow is then recorded immediately after the deflation, until a return to baseline flow is observed. An increase in blood flow above 30% will be considered success.
| At screening and 17 weeks later at last visit |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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