Low-Intensity Extracorporeal Shock Wave Therapy In Patients With Mild Or Moderate Erectile Dysfunction: A Randomized Clinical Trial

Objective: To evaluate the efficacy and safety of low-intensity extracorporeal shock wave therapy（Li-ESWT）in patients with mild or moderate erectile dysfunction by International Index of Erectile Function（IIEF-EF）questionnaire,erection hardness scale（EHS）questionnaire,SEP questionnaire,and GAQ questionnaire.Meanwhile,the possible mechanism of action was discussed based on relevant literature.Methods: A multi-center,sham-controlled,double-blind,randomized clinical trial,involved four medical centers in China.Firstly,in strict accordance with the standard set screening of the subjects,assess all conditions are met,the first basic demographic data and the baseline period erectile function evaluation and security checks.And then according to the center were randomly divided into the shock wave treatment group and the placebo group,the subjects four times,every 7±2 days for the corresponding category of shock wave therapy,The treatment time was about 20min（a total of 4 sites,200 times for each site,the treatment frequency was 2 times/second）,and local adverse reactions and subjective feelings of patients were observed during the treatment.Finally,all subjects were required to visit the hospital at 1,2,and 3 months after the end of 4treatments.Indicators of erectile function,including IIEF-EF score,EHS,SEP questionnaire,GAQ questionnaire,and patient satisfaction,were collected during the follow-up period.At the same time,laboratory safety indicators（blood routine,urine routine,blood biochemistry,etc.）were examined at baseline and the last follow-up period.In addition,record in detail the process of drug combination during the whole study,and record the pain and other possible adverse reactions during the whole study.Results: A total of 138 patients with mild and moderate erectile dysfunction were enrolled from June 2019 to March 2021,and were divided into shock wave group and control group according to the central randomization system in 2:1 order.A total of 112patients（81 in the shock wave group and 42 in the control group）participated in the final statistics.Demographic data of patients in the two groups and there was no statistical difference in baseline data（P> 0.05）,and the balance between groups was good and comparable.According to the statistical results,IIEF-EF scores of the shock wave group and the control group were 19.51±5.09 and 18.49±5.03,respectively,in the third month after treatment compared to the baseline period（P=0.229）.The increase in IIEF-EF score from baseline was 3.79± 4.32 and 2.37± 4.79（P=0.005）.The rates of treatment improvement（≥4 points increase from baseline score）with IIEF-EF score were 63.04%（95%CI 53.18%,72.91%）and 23.91%（11.59%,36.24%）（P< 0.001）,respectively.EHS scores 3 months after treatment were 2.82±0.61 and 2.84±0.65（P=0.971）.According to the SEP Q2 questionnaire,91.57% and 88.89% of subjects in the shock wave group could insert their partner’s vagina after erection at the first and second months after treatment,respectively,with statistically significant P values of0.005 and 0.037 compared with the control group.65.06% of participants in the sexual activity shock wave group said “Yes” 1 month after treatment（P=0.004）.After treatment,there was no obvious pain in the VAS score and no ecchymosis.There were8 mild adverse events during follow-up（6 in the experimental group and 2 in the control group）,all of which were not related to shock wave therapy.There were no serious adverse events.In addition,there was no clinical significance in related safety indexes between the shock wave group and the control group,and no significant statistical difference was found in the results（P>0.05）.Conclusion: Through the study of superior efficacy evaluation,it is shown that in vitro low-energy shock wave therapy has certain efficacy and high safety for mild to moderate erectile function,and can improve the spontaneous erectile function of some patients with erectile dysfunction in the short term,and has positive effects on IIEF-EF score improvement and subjective experience of patients.Therefore,a low-intensity shock wave may be a new treatment option for mild to moderate erectile dysfunction.