The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

No AccessJournal of UrologyAdult Urology1 Aug 2022The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial Dimitrios Kalyvianakis, Ioannis Mykoniatis, Nikolaos Pyrgidis, Paraskeui Kapoteli, Filimon Zilotis, Agrippina Fournaraki, and Dimitrios Hatzichristou Dimitrios KalyvianakisDimitrios Kalyvianakis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece , Ioannis MykoniatisIoannis Mykoniatis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece , Nikolaos PyrgidisNikolaos Pyrgidis *Correspondence: Institute for the Study of Urological Diseases, Alois 16, Pilaia, Thessaloniki, Greece telephone: 0030 6982 14 2006; FAX: 0030 2310 99 2543; E-mail Address: [email protected] https://orcid.org/0000-0002-7707-8426 Institute for the Study of Urological Diseases, Thessaloniki, Greece , Paraskeui KapoteliParaskeui Kapoteli First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece , Filimon ZilotisFilimon Zilotis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece , Agrippina FournarakiAgrippina Fournaraki First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece , and Dimitrios HatzichristouDimitrios Hatzichristou First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece View All Author Informationhttps://doi.org/10.1097/JU.0000000000002684AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We conducted the first double-blind, randomized, sham-controlled trial evaluating the efficacy and safety of low-intensity shock wave therapy (LiST) exclusively in patients with moderate erectile dysfunction. Materials and Methods: Seventy patients were randomized to 12 sessions of LiST (35) or sham therapy (35) twice weekly. Patients were evaluated at 1 and 3 months after completion of treatment. The proportion of participants attaining minimal clinically important difference (MCID) in the International Index of Erectile Function–Erectile Function (IIEF-EF) and the effect of LiST on erectile function, as well as on safety, were the study outcomes. Results: At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66–93, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4–5.4, p <0.001). At 1 month, MCID was attained by 20 (59%) patients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38–73, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7–5.2, p <0.001). 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JAMA Netw Open 2021; 4: e2036337. Google Scholar Support: The LiST device was provided by Dornier MedTech GmbH, Wessling, Germany. The Institute for the Study of Urological Diseases supported the trial. The funding institution reviewed only the design and conduct of the study. The funder had no role in the collection, management, analysis and interpretation of the data; in the preparation, review, or approval of the manuscript; or in the decision to submit the manuscript for publication. Wolters Kluwer, the publisher of The Journal of Urology®, made this article accessible online by all without charge through the PubMed Central (PMC) repository. Conflict of Interest: Dimitrios Hatzichristou is a speaker and investigator for Dornier MedTech GmbH. Author Contributions: All authors participated in the drafting, writing and editing of the manuscript. All gave final approval and agree to be accountable for all aspects of work, ensuring integrity and accuracy. Submission History: This paper was presented at the ESSM2022 Virtual Meeting on February 19, 2022. © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 208Issue 2August 2022Page: 388-395Supplementary Materials PEER REVIEW REPORT Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.Keywordsextracorporeal shockwave therapyrandomized controlled trialerectile dysfunctionMetricsAuthor Information Dimitrios Kalyvianakis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece More articles by this author Ioannis Mykoniatis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece More articles by this author Nikolaos Pyrgidis Institute for the Study of Urological Diseases, Thessaloniki, Greece *Correspondence: Institute for the Study of Urological Diseases, Alois 16, Pilaia, Thessaloniki, Greece telephone: 0030 6982 14 2006; FAX: 0030 2310 99 2543; E-mail Address: [email protected] More articles by this author Paraskeui Kapoteli First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece More articles by this author Filimon Zilotis First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece More articles by this author Agrippina Fournaraki First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece More articles by this author Dimitrios Hatzichristou First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece Institute for the Study of Urological Diseases, Thessaloniki, Greece More articles by this author Expand All Support: The LiST device was provided by Dornier MedTech GmbH, Wessling, Germany. The Institute for the Study of Urological Diseases supported the trial. The funding institution reviewed only the design and conduct of the study. The funder had no role in the collection, management, analysis and interpretation of the data; in the preparation, review, or approval of the manuscript; or in the decision to submit the manuscript for publication. Wolters Kluwer, the publisher of The Journal of Urology®, made this article accessible online by all without charge through the PubMed Central (PMC) repository. Conflict of Interest: Dimitrios Hatzichristou is a speaker and investigator for Dornier MedTech GmbH. Author Contributions: All authors participated in the drafting, writing and editing of the manuscript. All gave final approval and agree to be accountable for all aspects of work, ensuring integrity and accuracy. Submission History: This paper was presented at the ESSM2022 Virtual Meeting on February 19, 2022. Advertisement PDF downloadLoading ...