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This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Intensity Shockwave treatment | Experimental | 4 weekly sessions of Low Intensity Shockwave treatment. |
|
| Control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Intensity Shockwave by Renova | Device |
| ||
| Sham treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment | 1, 3 and 6 months post treatment | |
| Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20451317 | Background | Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6. | |
| 22425129 | Background |
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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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| Device |
Sham treatment that looks, sounds and feels like the real LISW treatment. |
|
| Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment | 1, 3 and 6 months post treatment |
| Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment | 0 and 6 months post treatment |
| Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15. |
| 12152111 | Background | Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857. |
| 21855209 | Background | Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |