The Clinical Research Of Low-intensity Pulsed Ultrasound On Treating Erectile Dysfunction

Objective: Our study aims to investigate the feasibility,effect and safety of Low-intensity Pulsed Ultrasound Therapy(Li-PUST)as a novel treatment for erectile dysfunction(ED).Meantime,combined with relevant literature,the mechanism of the influence on penile organization will be analyzed.Method: A total of 24 ED patients were recruited and assigned into control group or experimental group randomly in this pilot study according to the inclusion and exclusion criteria.After 4-week washout period of phosphodiesterase 5 inhibitors(PDE5-i),demographic characteristics and baseline data of erectile function were collected.Then 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 five-item International Index of Erectile Function(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(blood and urine routine included).Any adverse effect appearing during the trial and concomitant medication should be recorded detailly.Result: In total,24 patients were enrolled in this protocol.1 patient in placebo group was excluded due to use of PDE5-i 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 by 4 patients and no other adverse events were noted during follow-up.At t1,IIEF-5 score of 56.25% patients in Li-PUST group increased by at least 2 points while none in place group(P = 0.01).At t2,the responsive patients increased to 68.75% whereas only 14.29% in placebo group(P = 0.02).At t3,the percent of valid cases in Li-PUST group got to 75% and there were still 28.57% in placebo group(P = 0.05).Conclusion: This is the first clinical pilot study that proved the efficacy and safety of Li-PUST for ED.The short-term results hint that the application of Li-PUST in the ED patients may cure ED without any dependency or adverse effect from pathology,which contributes to the recovery of penis vascular endothelial function.