Artigo Revisado por pares

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

2012; Lippincott Williams & Wilkins; Volume: 187; Issue: 5 Linguagem: Inglês

10.1016/j.juro.2011.12.117

ISSN

1527-3792

Autores

Yoram Vardi, Boaz Appel, Amichai Kilchevsky, Ilan Gruenwald,

Tópico(s)

Hormonal and reproductive studies

Resumo

No AccessJournal of UrologyAdult Urology1 May 2012Does Low Intensity Extracorporeal Shock Wave Therapy Have a Physiological Effect on Erectile Function? Short-Term Results of a Randomized, Double-Blind, Sham Controlled Study Yoram Vardi, Boaz Appel, Amichai Kilchevsky, and Ilan Gruenwald Yoram VardiYoram Vardi Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel Financial interest and/or other relationship with Medispec, Ltd. More articles by this author , Boaz AppelBoaz Appel Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel More articles by this author , Amichai KilchevskyAmichai Kilchevsky Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel Department of Urology, Yale-New Haven Hospital, New Haven, Connecticut More articles by this author , and Ilan GruenwaldIlan Gruenwald Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.12.117AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We investigated the clinical and physiological effect of low intensity extracorporeal shock wave therapy on men with organic erectile dysfunction who are phosphodiesterase type 5 inhibitor responders. Materials and Methods: After a 1-month phosphodiesterase type 5 inhibitor washout period, 67 men were randomized in a 2:1 ratio to receive 12 sessions of low intensity extracorporeal shock wave therapy or sham therapy. Erectile function and penile hemodynamics were assessed before the first treatment (visit 1) and 1 month after the final treatment (followup 1) using validated sexual function questionnaires and venoocclusive strain gauge plethysmography. Results: Clinically we found a significantly greater increase in the International Index of Erectile Function-Erectile Function domain score from visit 1 to followup 1 in the treated group than in the sham treated group (mean ± SEM 6.7 ± 0.9 vs 3.0 ± 1.4, p = 0.0322). There were 19 men in the treated group who were initially unable to achieve erections hard enough for penetration (Erection Hardness Score 2 or less) who were able to achieve erections sufficiently firm for penetration (Erection Hardness Score 3 or greater) after low intensity extracorporeal shock wave therapy, compared to none in the sham group. Physiologically penile hemodynamics significantly improved in the treated group but not in the sham group (maximal post-ischemic penile blood flow 8.2 vs 0.1 ml per minute per dl, p <0.0001). None of the men experienced discomfort or reported any adverse effects from the treatment. Conclusions: This is the first randomized, double-blind, sham controlled study to our knowledge that shows that low intensity extracorporeal shock wave therapy has a positive short-term clinical and physiological effect on the erectile function of men who respond to oral phosphodiesterase type 5 inhibitor therapy. The feasibility and tolerability of this treatment, coupled with its potential rehabilitative characteristics, make it an attractive new therapeutic option for men with erectile dysfunction. References 1 : Endothelial apoptosis decrease following tadalafil administration in patients with arterial ED does not last after its discontinuation. Int J Impot Res2011; 23: 200. Google Scholar 2 : hMaxi-K gene transfer in males with erectile dysfunction: results of the first human trial. Hum Gene Ther2006; 17: 1165. Google Scholar 3 : Gene and stem cell therapy for erectile dysfunction. Int J Impot Res2005; 17: S57. Google Scholar 4 : Can low-intensity extracorporeal shockwave therapy improve erectile function?: A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol2010; 58: 243. Google Scholar 5 : Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med2012; 9: 259. Google Scholar 6 : The effect of therapeutic ultrasound on angiogenesis. Ultrasound Med Biol1990; 16: 261. Google Scholar 7 : Shock waves activate in vitro cultured progenitors and precursors of cardiac cell lineages from the human heart. Ultrasound Med Biol2008; 34: 334. Google Scholar 8 : An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J2003; 26: 220. Google Scholar 9 : Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J2010; 74: 589. Google Scholar 10 : Influence of shock waves on fracture healing. Urology1992; 39: 529. Google Scholar 11 : Extracorporal shock wave therapy for calcifying tendinitis of the shoulder. Clin Orthop Relat Res1995; 321: 196. Google Scholar 12 : Extracorporeal shockwave treatment for chronic diabetic foot ulcers. J Surg Res2009; 152: 96. Google Scholar 13 : A new clinical method for the assessment of penile endothelial function using the flow mediated dilation with plethysmography technique. J Urol2005; 173: 1268. Link, Google Scholar 14 : Penile and systemic endothelial function in men with and without erectile dysfunction. Eur Urol2009; 55: 979. Google Scholar 15 : Validation of the erection hardness score. J Sex Med2007; 4: 1626. Google Scholar 16 : The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology1997; 49: 822. Crossref, Medline, Google Scholar 17 : The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res2002; 14: 226. Google Scholar 18 : Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med1998; 338: 1397. Google Scholar 19 : The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Impot Res2001; 13: 192. Google Scholar 20 : Efficacy and safety of tadalafil for the treatment of erectile dysfunctions: results of integrated analyses. J Urol2002; 168: 1332. Link, Google Scholar 21 : Near-normalization of erectile function and improvement of psychosocial quality-of-life in men with erectile dysfunction treated with Viagra® (sildenafil citrate). J Sex Med2005; 2: 83. Google Scholar 22 : Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: results from MOMENTUS: Multiple Observations in Men with Erectile Dysfunction in National Tadalafil Study in the US. J Sex Med2007; 4: 166. Google Scholar 23 : Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification. J Sex Med2004; 1: 301. Google Scholar 24 : Revascularization with extracorporeal shock wave therapy: first clinical results. Circulation1999; 100: 84. Google Scholar 25 : Extracorporeal cardiac shock wave therapy: first experience in the everyday practice for treatment of chronic refractory angina pectoris. Int J Cardiol2007; 121: 84. Google Scholar 26 : Extracorporeal shock wave therapy in the treatment of Peyronie's disease: long-term results. Arch Ital Urol Androl2010; 82: 128. Google Scholar 27 : Long-term results of extracorporeal shockwave therapy for Peyronie's disease. J Endourol2006; 20: 880. Google Scholar 28 : The impact of shock wave therapy at varied energy and dose levels on functional and structural changes in erectile tissue. Eur Urol2008; 53: 635. Google Scholar © 2012 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.Weinberger J, Shahinyan G, Yang S, Shahinyan R, Mills J and Eleswarapu S (2022) Reply by AuthorsUrology Practice, VOL. 9, NO. 3, (219-219), Online publication date: 1-May-2022.Weinberger J, Shahinyan G, Yang S, Shahinyan R, Mills J and Eleswarapu S (2022) Shock Wave Therapy for Erectile Dysfunction: Marketing and Practice Trends in Major Metropolitan Areas in the United StatesUrology Practice, VOL. 9, NO. 3, (212-219), Online publication date: 1-May-2022.Burnett A, Nehra A, Breau R, Culkin D, Faraday M, Hakim L, Heidelbaugh J, Khera M, McVary K, Miner M, Nelson C, Sadeghi-Nejad H, Seftel A and Shindel A (2018) Erectile Dysfunction: AUA GuidelineJournal of Urology, VOL. 200, NO. 3, (633-641), Online publication date: 1-Sep-2018.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.Assaly-Kaddoum R, Giuliano F, Laurin M, Gorny D, Kergoat M, Bernabé J, Vardi Y, Alexandre L and Behr-Roussel D (2016) Low Intensity Extracorporeal Shock Wave Therapy Improves Erectile Function in a Model of Type II Diabetes Independently of NO/cGMP PathwayJournal of Urology, VOL. 196, NO. 3, (950-956), Online publication date: 1-Sep-2016.Chuang Y, Huang T, Tyagi P and Huang C (2015) Urodynamic and Immunohistochemical Evaluation of Intravesical Botulinum Toxin A Delivery Using Low Energy Shock WavesJournal of Urology, VOL. 196, NO. 2, (599-608), Online publication date: 1-Aug-2016.Kitrey N, Gruenwald I, Appel B, Shechter A, Massarwa O and Vardi Y (2015) Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled StudyJournal of Urology, VOL. 195, NO. 5, (1550-1555), Online publication date: 1-May-2016. Volume 187Issue 5May 2012Page: 1769-1775 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.Keywordspenishigh-energy shock waveserectile dysfunctionhemodynamicsAcknowledgmentsElliot Sprecher assisted with the statistical analysis and Dr. Arieh Bomzon provided assistance.Metrics Author Information Yoram Vardi Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel Financial interest and/or other relationship with Medispec, Ltd. More articles by this author Boaz Appel Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel More articles by this author Amichai Kilchevsky Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel Department of Urology, Yale-New Haven Hospital, New Haven, Connecticut More articles by this author Ilan Gruenwald Neuro-Urology Unit, Rambam Healthcare Campus, and the Rappaport Faculty of Medicine, Technion – IIT, Haifa, Israel More articles by this author Expand All Advertisement PDF downloadLoading ...

Referência(s)
Altmetric
PlumX