Low-intensity pulsed ultrasound therapy as a novel treatment for erectile dysfunction: a prospective, randomized, double-blind, placebo-controlled pilot study
Peng, C1; Li, GG2; Li, DY1; Dong, ZL1; Wang, ZP1
1: Lanzhou University Second Hospital, China; 2: School of Public Health, Lanzhou University,China
Objective: To investigate the feasibility, effect, safety and patient satisfactory degree of Low-intensity Pulsed Ultrasound Therapy(Li-PUST) as a treatment for erectile dysfunction(ED) without any medicine or other operation aimed at ED.
Material and Methods: A total of 24 patients, who suffered from mild to moderate ED according to five-item version of the International Index of Erectile Function(IIEF-5), were recruited and assigned into control group and experimental group randomly in this pilot study. Treatment lasting for 4 weeks was operated twice a week. The effect of the treatment was evaluated 0 week(t1), 4 weeks(t2) and 8 weeks(t3) after the final treatment respectively mainly depending on the IIEF-5, Erectile Hardness Scale(EHS) and patient satisfaction rate, while the safety of the therapy was observed by Visual Analogue Scale(VAS) and laboratory tests.
Results: 24 middle-aged men with mid to severe ED were enrolled. 1 patient was excluded due to a use of phosphodiesterase type 5 inhibitors (PDE5Is) during the trial. Compared with baseline, Li-PUST group showed a significant improvement on IIEF-5 at t1(13.00±3.54 vs 15.00±3.31, P < 0.001); it remained at t2 and became even better at t3(13.00±3.54 vs 17.44±3.85, P < 0.001). In addition, the sexual quality of life of Li-PUST was significantly improved (P < 0.05), too. Moreover, significant increases in penile rigidity were demonstrated. But statistically significant improvements were not found in placebo group. Slight pain was reported from a few patients and no other adverse events were noted during follow-up.
Conclusions: This is the first study that proved the efficacy and safety of Li-PUST for ED. The short-term results stands for the application of Li-PUST in the ED patients with the hope that this kind of novel therapy may radically cure ED without any dependency and adverse effect. However, the mechanism of it still remains to be explored and further evaluation with longer follow-up as well as larger sham-control cohorts is required.
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