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This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shockwaves | Low intensity linear focused shockwave device ('Renova') |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low intensity linear focused shockwave device ('Renova') | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 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 1, 3 and 6 months post treatment | 1, 3 and 6 months post treatment | |
| Responses to the GAQ (Global Assessment questions) Questions 1 and 2 at 1, 3 and 6 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Sexual Medicine clinic
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| Name | Affiliation | Role |
|---|---|---|
| Cobi Reisman, MD, PhD | Men's Health Clinic, Amstelland Hospital, Amsterdam, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urologickaambulance | Brno | Czechia | ||||
| Amber Clinic |
| 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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| 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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| 1, 3 and 6 months post treatment |
| Klaipėda |
| Lithuania |
| Men's Health Clinic, Amstelland Hospital | Amsterdam | Netherlands |
| Urology and Andrology Center, Red Crescent Hospital (RCH) | Ramallah | Palestinian Territories |
| 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. |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |