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The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| long protocol | Experimental | Renova |
|
| short protocol | Experimental | Renova |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renova | Device | Low- Intensity Shockwave |
|
| Measure | Description | Time Frame |
|---|---|---|
| IIEF-EF- International Index of Erectile Function questionnaire score | the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment | 1 month post treatment |
| IIEF-EF questionnaire score | 3 months post treatment | |
| IIEF-EF questionnaire score | the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment | 6 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SEP- Sexual Encounter Profile: Questions 2 and 3 | 1, 3 and 6 months post treatment | |
| GAQ- Global Assessment Questions | 1, 3 and 6 months post treatment | |
| EHS- Erection Hardness Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastchester Center for Cancer Care | New York | New York | 10469 | United States |
| 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. | |
| 22999553 | Background |
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| 1, 3 and 6 months post treatment |
| Goyal NK, Garg M, Goel A. Re: 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: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available. |
| 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. |