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| Name | Class |
|---|---|
| Medispec | INDUSTRY |
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Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of swt to convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i therapy. This study further emphasises the physiological effect that LI-ESWT can have on the erectile mechanism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LI-ESWT | Experimental | Low intensity shock wave treatment- 12 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LI-ESWT | Device | Low intensity shock wave treatment - 12 sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| IIEF-ED Domain score | Change of 5 points and above in IIEF-ED Domain score | 17 weeks after first visit |
| Measure | Description | Time Frame |
|---|---|---|
| rigidity scale | a change to 3 or 4 points in the rigidty scale | 17 weeks from visit 1 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Vardi, Prof | Rambam Health Care Campus | Principal Investigator |
| Ilan Gruenwald, MD | Rambam Health Care Campus | Study Director |
| Boaz Appel, MD | Rambam Health Care Campus | Study Director |
| Ezra Gerber, RN | Rambam Health Care Campus | Study Director |
| Yaron Ofer, MD | Rambam Health Care Campus | Study Director |
| Omar Massarwa, RN | Rambam Health Care Campus | Study Director |
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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 |