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I. Mykoniatis, D. Kalyvianakis, E. Memmos, P. Kapoteli, D. Memmos, D. Hatzichristou, PS-05-005 Low-intensity Shockwave Therapy for Erectile Dysfunction: 6 Months Follow-up Results of a Randomized Clinical Trial Assessing the Impact of Energy Flux Density and Frequency of Sessions, The Journal of Sexual Medicine, Volume 16, Issue Supplement_2, May 2019, Page S15, https://doi.org/10.1016/j.jsxm.2019.03.074
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Objective
The impact of energy flux density (EFD) used on Low-intensity Shockwave Therapy (LiST) for erectile dysfunction (ED) has not be explored. Furthermore, safety and efficacy of sessions frequency has not been established. Our aim was to compare EFD of 0.05 vs 0.096 mJ/mm2 regarding efficacy and safety of 12 treatment sessions within a 6-week period, when applied twice or 3 times per week.
Methods
Patients with vasculogenic ED, PDE5 inhibitors responders, were randomized into 4 groups, to receive 12 LiST sessions, using Dornier Aries2 shockwave machine: Group A=2 sessions/week with EFD 0.05mJ/mm2; Group B=3 sessions/week with EFD 0.05mJ/mm2; Group C=2 sessions/week with EFD 0.096mJ/mm2; Group D=3 sessions/week with EFD 0.096mJ/mm2. Follow up (FU) period was 6 months. Erectile function was assessed by International Index for Erectile Function – Erectile Function domain (IIEF-EF), Minimally Clinical Important Differences (MCID), Sexual Encounter Profile (SEP) and triplex ultrasonography parameters.
Results
All 4 groups improved in IIEF-EF, SEP3 “Yes’’ response at 6-month FU visit compared to baseline (p< 0.001). MCID at 6-month FU visit were achieved in 82.6%, 77.3% ,87%, 81% in Groups A(n=23), B(n=22), C(n=23), D (n=21) respectively. Mean PSV (cm/s) at baseline vs 3m-FU visit were 30.32 vs 34.67 for Group A, 30.02 vs 35.02 for Group B, 30.2 vs 36.02, for Group C, 29.43 vs 34.3 for Group D ( p<0.01). There was no statistically significant difference in the change of all outcome measures from baseline to 6 month FU visit between different frequency or EFD groups (Picture 1). No treatment-related side-effects were reported.
