{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:24:01Z","timestamp":1790742241193,"version":"4.1.0"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2024,4,10]],"date-time":"2024-04-10T00:00:00Z","timestamp":1712707200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Institute for the Study of Urological Diseases"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,5,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients with severe erectile dysfunction (ED) remain the most challenging group in terms of available noninvasive treatment modalities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>The study sought to assess the role of combination therapy with low-intensity shockwave therapy (LiST) and daily tadalafil 5\u00a0mg in a highly select group of patients with severe vasculogenic ED through a double-blind, randomized trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Forty-eight sexually active men were randomly assigned to 12 sessions of LiST 3 times weekly and tadalafil 5\u00a0mg once daily (n\u2009=\u200934) or sham therapy and tadalafil (n\u2009=\u200917) for 4 weeks. Patients were assessed at 1 and 3 months after completion of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>Improvement of erectile function was evaluated through the International Index of Erectile Function\u2013Erectile Function domain (IIEF-EF) or 6-item IIEF and the Sexual Encounter Profile (SEP) diary. The primary outcome was the difference between the groups in the IIEF-EF at 3 months after completion of treatment. Secondary outcomes comprised (1) the difference between the groups in the IIEF-EF at 1 month after completion of treatment, (2) the difference between the groups in the \u201cyes\u201d responses to question 3 of the SEP diary at 1 and 3 months, and (3) the treatment-related adverse events. The number of patients attaining a minimal clinically important difference in the IIEF-EF (improvement of at least 7 points) was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>After treatment, the absolute scores in the IIEF-EF were higher in patients receiving LiST and tadalafil vs sham therapy and tadalafil both at the 1-month (12.1\u2009\u00b1\u20092.4 vs 10.2\u2009\u00b1\u20091.7; P = .002) and at the 3-month (12.9\u2009\u00b1\u20092.1 vs 10.8\u2009\u00b1\u20091.8; P &amp;lt; .001) evaluation. Between the 2 groups, the proportion of \u201cyes\u201d responses to question 3 of the SEP diary was not statistically significant, whereas the number of patients attaining a minimal clinically important difference in the IIEF-EF was statistically significant only at the 3-month evaluation. No adverse events occurred.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Implications<\/jats:title>\n                    <jats:p>Application of LiST in patients with severe vasculogenic ED receiving daily dose tadalafil may further improve erectile function compared with tadalafil as a stand-alone treatment on the short term.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Strengths and Limitations<\/jats:title>\n                    <jats:p>Although we provided the first study in the field, severe vasculogenic ED was defined based on medical history and clinical examination and not based on penile ultrasound measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The combination of 12 sessions LiST 3 times weekly and daily tadalafil for 4 weeks led to a 2-point difference in the IIEF-EF compared with sham therapy and daily tadalafil among patients with severe vasculogenic ED after 1 and 3 months from completion of treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jsxmed\/qdae038","type":"journal-article","created":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T09:17:11Z","timestamp":1709889431000},"page":"533-538","source":"Crossref","is-referenced-by-count":17,"title":["The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial"],"prefix":"10.1093","volume":"21","author":[{"given":"Dimitrios","family":"Kalyvianakis","sequence":"first","affiliation":[{"name":"Aristotle University of Thessaloniki Department of Urology, , Thessaloniki 54635, Greece"},{"name":"Institute for the Study of Urological Diseases , Thessaloniki 54622, 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