PMID- 35830338 OWN - NLM STAT- MEDLINE DCOM- 20220715 LR - 20230214 IS - 1527-3792 (Electronic) IS - 0022-5347 (Linking) VI - 208 IP - 2 DP - 2022 Aug TI - The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. PG - 388-395 LID - 10.1097/JU.0000000000002684 [doi] AB - 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). CONCLUSIONS: Twelve sessions of LiST twice weekly for 6 weeks with a treatment protocol of 5,000 impulses, 0.096 mJ/mm(2) energy flux density and 5 Hz frequency are highly effective in patients with moderate erectile dysfunction. Still, further long-term randomized studies are warranted to corroborate our findings. FAU - Kalyvianakis, Dimitrios AU - Kalyvianakis D AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. AD - Institute for the Study of Urological Diseases, Thessaloniki, Greece. FAU - Mykoniatis, Ioannis AU - Mykoniatis I AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. AD - Institute for the Study of Urological Diseases, Thessaloniki, Greece. FAU - Pyrgidis, Nikolaos AU - Pyrgidis N AUID- ORCID: 0000-0002-7707-8426 AD - Institute for the Study of Urological Diseases, Thessaloniki, Greece. FAU - Kapoteli, Paraskeui AU - Kapoteli P AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. FAU - Zilotis, Filimon AU - Zilotis F AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. FAU - Fournaraki, Agrippina AU - Fournaraki A AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. FAU - Hatzichristou, Dimitrios AU - Hatzichristou D AD - First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. AD - Institute for the Study of Urological Diseases, Thessaloniki, Greece. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220506 PL - United States TA - J Urol JT - The Journal of urology JID - 0376374 SB - IM CIN - Int Braz J Urol. 2023 Jan-Feb;49(1):152-154. PMID: 36512464 MH - Double-Blind Method MH - *Erectile Dysfunction MH - *Extracorporeal Shockwave Therapy/methods MH - Humans MH - Male MH - Penile Erection MH - Treatment Outcome OTO - NOTNLM OT - erectile dysfunction OT - extracorporeal shockwave therapy OT - randomized controlled trial EDAT- 2022/07/14 06:00 MHDA- 2022/07/16 06:00 CRDT- 2022/07/13 12:59 PHST- 2022/07/13 12:59 [entrez] PHST- 2022/07/14 06:00 [pubmed] PHST- 2022/07/16 06:00 [medline] AID - 10.1097/JU.0000000000002684 [doi] PST - ppublish SO - J Urol. 2022 Aug;208(2):388-395. doi: 10.1097/JU.0000000000002684. Epub 2022 May 6.