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Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study

2015; Lippincott Williams & Wilkins; Volume: 195; Issue: 5 Linguagem: Inglês

10.1016/j.juro.2015.12.049

1527-3792

Noam D. Kitrey, Ilan Gruenwald, Boaz Appel, Arik Shechter, O. Massarwa, Yoram Vardi,

Urinary Bladder and Prostate Research

No AccessJournal of UrologyAdult Urology1 May 2016Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study Noam D. Kitrey, Ilan Gruenwald, Boaz Appel, Arik Shechter, Omar Massarwa, and Yoram Vardi Noam D. KitreyNoam D. Kitrey Urology Department, Sheba Medical Center, Tel-Hashomer, Israel , Ilan GruenwaldIlan Gruenwald Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel , Boaz AppelBoaz Appel Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel , Arik ShechterArik Shechter Department of Family Medicine, Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Clalit Health Services, Haifa, Israel , Omar MassarwaOmar Massarwa Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel , and Yoram VardiYoram Vardi Urology Department, Sheba Medical Center, Tel-Hashomer, Israel View All Author Informationhttps://doi.org/10.1016/j.juro.2015.12.049AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We performed sham controlled evaluation of penile low intensity shock wave treatment effect in patients unable to achieve sexual intercourse using PDE5i (phosphodiesterase type 5 inhibitor). Materials and Methods: This prospective, randomized, double-blind, sham controlled study was done in patients with vasculogenic erectile dysfunction who stopped using PDE5i due to no efficacy. All patients had an erection hardness score of 2 or less with PDE5i. A total of 58 patients were randomized, including 37 treated with low intensity shock waves (12 sessions of 1,500 pulses of 0.09 mJ/mm2 at 120 shock waves per minute) and 18 treated with a sham probe. In the sham group 16 patients underwent low intensity shock wave treatment 1 month after sham treatment. All patients were evaluated at baseline and 1 month after the end of treatment using validated erectile dysfunction questionnaires and the flow mediated dilatation technique for penile endothelial function. Erectile function was evaluated while patients were receiving PDE5i. Results: In the low intensity shock wave treatment group and the sham group 54.1% and 0% of patients, respectively, achieved erection hard enough for vaginal penetration, that is an EHS (Erection Hardness Score) of 3 (p <0.0001). According to changes in the IIEF-EF (International Index of Erectile Function-Erectile Function) score treatment was effective in 40.5% of men who received low intensity shock wave treatment but in none in the sham group (p = 0.001). Of patients treated with shock waves after sham treatment 56.3% achieved erection hard enough for penetration (p <0.005). Conclusions: Low intensity shock wave treatment is effective even in patients with severe erectile dysfunction who are PDE5i nonresponders. After treatment about half of them were able to achieve erection hard enough for penetration with PDE5i. Longer followup is needed to establish the place of low intensity shock wave treatment in these challenging cases. 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Google Scholar © 2016 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byKalyvianakis D, Mykoniatis I, Pyrgidis N, Kapoteli P, Zilotis F, Fournaraki A and Hatzichristou D (2022) The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical TrialJournal of Urology, VOL. 208, NO. 2, (388-395), Online publication date: 1-Aug-2022.Kitrey N, Vardi Y, Appel B, Shechter A, Massarwi O, Abu-Ghanem Y and Gruenwald I (2018) Low Intensity Shock Wave Treatment for Erectile Dysfunction—How Long Does the Effect Last?Journal of Urology, VOL. 200, NO. 1, (167-170), Online publication date: 1-Jul-2018.Seftel A (2017) Re: Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients with Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled TrialJournal of Urology, VOL. 198, NO. 5, (964-964), Online publication date: 1-Nov-2017. Volume 195Issue 5May 2016Page: 1550-1555 Advertisement Copyright & Permissions© 2016 by American Urological Association Education and Research, Inc.Keywordshigh energy shock wavesphosphodiesterase 5 inhibitorsquestionnairestestiserectile dysfunctionAcknowledgmentsEliot Sprecher assisted with statistical analysis. Medispec provided the Omnispec ED1000 electrohydraulic unit.MetricsAuthor Information Noam D. Kitrey Urology Department, Sheba Medical Center, Tel-Hashomer, Israel No direct or indirect commercial incentive associated with publishing this article. More articles by this author Ilan Gruenwald Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel No direct or indirect commercial incentive associated with publishing this article. More articles by this author Boaz Appel Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel Financial interest and/or other relationship with Medispec. More articles by this author Arik Shechter Department of Family Medicine, Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Clalit Health Services, Haifa, Israel No direct or indirect commercial incentive associated with publishing this article. More articles by this author Omar Massarwa Neurourology Unit, Rambam Healthcare Campus, Haifa, Israel No direct or indirect commercial incentive associated with publishing this article. More articles by this author Yoram Vardi Urology Department, Sheba Medical Center, Tel-Hashomer, Israel Financial interest and/or other relationship with Medispec. More articles by this author Expand All Advertisement PDF downloadLoading ...