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P.B. Ladegaard, J. Mortensen, L. Lund, HP-08-007 A Prospective Randomized Placebo Controlled Study Evaluating the Effect of Low-intensity Extracorporeal Shockwave Therapy (LI-ESWT) in Men with Erectile Dysfunction Following Radical Prostatectomy, The Journal of Sexual Medicine, Volume 16, Issue Supplement_2, May 2019, Page S46, https://doi.org/10.1016/j.jsxm.2019.03.158
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Objective
Previous studies have showed that low-intensity extracorporeal shockwave therapy (Li-ESWT) can improve male erectile dysfunction (ED) of vascular etiology. We want to investigate the effect of Li-ESWT, in a randomized, placebo-controlled trial, in men following radical prostatectomy (RP).
Methods
Men with ED following nerve-sparing RP, with ED score < 22, based on the 5-item international index of erectile function (IIEF-5) questionnaire were included. Participants were divided into an active (n=18) and a placebo/sham group (n=16). They were block-randomized consecutively when entering the study. Each group had one Li_ESWT treatment a week for five weeks, using the Duolith® SD1 shockwave machine (Storz Medical). Median change (MC) in erectile function (EF) scores were evaluated by international validated questionnaires, erection hardness score (EHS) and IIEF-5 at baseline and by 4 (F1) and 12 weeks (F2) after last treatment respectively.
Results
A total of thirty-four (n=34) participants were enrolled. thirty-two participants (n=18, active and n=14, placebo) reached F1 before deadline of this abstract. No dropouts were registered throughout the study period. Ten participants in the active group (55%) improved EF at F1. MC of IIEF-5 and EHS in the active group was 2 and 0 respectively. MC for IIEF-5 was statistically significant (p=0,03). In the placebo group, MC in IIEF-5 was 1 and 0 in EHS (not significant).