Clinical Study Of Low-intensity Extracorporeal Shock Wave Treatment Of Erectile Dysfunction That Does Not Respond To PDE5i

Background: The prevalence of ED in men is increasing year by year,and it has become an important disease affecting men’s health and seriously interfering with the pace of life.The etiology of ED involves many factors such as neurological,vascular,hormonal,psychological and so on.Before treatment,the patients themselves and their social factors should be comprehensively evaluated,and individualized treatment plans that are effective,safe,and easy to accept by patients should be formulated.At present,there are various treatment methods for ED.One of the first-line treatment methods is oral phosphodiesterase-5 inhibitor(PDE5i),which has been often used in the treatment of the disease due to its reliable safety and high efficiency.Over 30% ED patients show poor response to PDE5 i treatment.These patients often suffer from basic diseases such as diabetes,hypertension,cardiovascular disease,or hypogonadism,and endocrine diseases such as thyroid.In addition,PDE5 i has various adverse reactions and complications,such as headache,nausea,facial flushing,etc.during the course of taking PDE5 i,and cannot be used consistently.Non-responder PDEi5 patients can also choose other treatment methods including: intraurethral administration,application of negative pressure erection aids,and injection of vasoactive drugs into the cavernous body of the penis.For severe ED patients,you can choose penile prosthesis implantation and penile vascular surgery treatment.But because of its inconvenience,complications,and invasiveness,it is difficult for most ED patients to accept it.In the past decade,low-intensity extracorporeal shock waves(Li-ESWT)have been used in the clinical treatment of ED,and the treatment methods and basic theories have been greatly updated.As a non-invasive micro-energy treatment method,it is expected to fundamentally repair the pathological damage of the penis,thereby improving the erection status of ED patients,and it has the characteristics of high safety,good curative effect and few complications.However,there are few clinical application studies of Li-ESWT for non-responder PDEi5 patients,and its safety and efficacy need to be further confirmed,and the treatment parameters of each clinical study are different,resulting in a large difference in the treatment effect.Therefore,we prospectively investigated the treatment of Li-ESWT for non-responder PDEi5 patients.This article aims to introduce Li-ESWT in the treatment of non-responder PDEi5 patients through International Index of Erectile Function-erectile function domain(IIEF-EF),Erection Hardness Score(EHS),Sexual Encounter Profile question(SEP),Global Assessment Questionnaire question(GAQ)and other efficacy evaluation indicators treatment effect and adverse reactions of patients.Objective: The purpose of this clinical trial is to explore the clinical effect and safety of low-intensity extracorporeal shock wave therapy PDE5 i in patients with non-responsive erectile dysfunction.It provides a safe and effective treatment option for patients with non-responder PDEi5 patients.Methods: According to the relevant research design,the study was divided into three stages:screening,treatment,and follow-up.150 cases of ED patients with PDE5 i non-responsiveness who met the enrollment conditions in the outpatient clinic were selected as the research objects.They were randomly divided into three groups: Li-ESWT+PDE5i(LP)treatment group,Li-ESWT treatment group,and PDE5 i treatment group.Physical,medical history and reproductive hormone tests were performed at the screening stage,and patients were strictly enrolled according to the inclusion and exclusion criteria.During the treatment and follow-up period,all patients in the Li-ESWT+PDE5i treatment group and PDE5 i treatment group were treated with sildenafil citrate 100 mg tablets as needed,while the Li-ESWT treatment group only used low-energy shock wave regular treatment.Before treatment,the baseline values of the patient’s condition including IIEF-EF,EHS score and SEP-2,SEP-3 and NPT parameters were sorted and recorded.Use Li-ESWT for treatment,2 times a week,after 3 weeks of treatment,3 weeks of intermittent treatment and then 3 weeks of treatment,a total of 12 treatments,set the energy density of 0.09 m J/mm~2,the pulse frequency is 120 times/min,the 5 treatment points of the distal,middle,proximal and left and right penis feet were impacted 300 times each time,1500 times in total.The patients were followed up 13 weeks after treatment and 17 weeks after treatment.The follow-up indicators included the International Erectile Function Score(IIEF-EF),Erection Hardness Rating(EHS),Sexual Activity Log(SEP),Comprehensive Evaluation Questionnaire(GAQ),Night penile erection monitoring(NPT),the patient’s NPT parameters were followed up at the 17 th week.Results: A total of 150 patients were enrolled into the study,and 150 people were randomly divided into groups: LP group,L group,and P group,each with 50 people,and the three different treatment effects were compared with each other.During the study period,24 patients did not complete the follow-up treatment,and the remaining 126 patients completed the study.Among them,46 persons were in the Li-ESWT+PDE5i treatment group,42 persons were in the Li-ESWT treatment group,and 38 persons were in the PDE5 i treatment group.The average age of 126 patients was(46.48±7.61)years.IIEF score:The average score of IIEF-EF in the 2 follow-up visits after treatment in the LP treatment group was significantly different from that before treatment.The average IIEF-EF scores of the ED patients in the L group were significantly different after the second follow-up treatment compared with those before the treatment.There was no significant difference in the mean score of IIEF-EF of ED patients in group P before treatment and 2 follow-up visits after treatment.The three groups also had significant differences in the follow-up data after treatment;the EHS: LP treatment group had a significant difference in the average score of IIEF-EF during the 2 follow-up visits after treatment and before treatment.The average IIEF-EF scores of the ED patients in the L group were significantly different after the second follow-up treatment compared with those before the treatment.There was no significant difference between the two follow-up visits before treatment and after treatment for ED patients in group P.In comparison between the groups,there was no significant difference between the LP group,the L group and the P group before treatment,but there were significant differences between the groups at 13 weeks and the 17 th week after treatment.SEP and GAQ: A total of 4 questions,the patients answered "Yes" and "Yes" follow-up status;LP group and L group ED patients answered "Yes" to both SEP2 and SEP3 questions at the 13 th and 17 th weeks after the start of treatment.It is a great improvement compared to before treatment.In addition,the ED patients in the LP group had significant differences in the answers to GAQ1 and GAQ2 between the13 th and 17 th weeks of treatment.The ED patients in the P group had no significant changes in the answers to the four questions of SEP2,SEP3,GAQ1 and GAQ2.NPT parameters: According to the results of NPTR monitoring,there were no significant differences in the average hardness of the head of the penis,the average hardness of the root of the penis,and the total number of erectile events in the first three groups of ED patients.In the 17 th week after treatment,the average hardness of the head of the penis,the average hardness of the root of the penis,and the total number of erectile events in the LP group were significantly improved compared with before treatment.However,in the L group of ED patients,the NPT parameters and the data before treatment improved at the 17 th week after treatment,but the difference before and after treatment was not significant.There was no significant difference in the data of night erection before treatment and 17 weeks after treatment in the P group.Data comparison between the three groups showed that the average hardness of the head of the penis,the average hardness of the root of the penis,and the total number of erectile events in the LP group were significantly different from those in the L and P groups.During the treatment and follow-up period,2 Li-ESWT-treated patients developed penile skin pain,slight redness and swelling,and the treatment was not interrupted;18 patients had mild headache during oral PDE5 i,and 6 patients had facial flushing.None of the treatment was interrupted,and no adverse reactions were found in the remaining patients.Conclusion: This article mainly studied the efficacy and safety of low-energy extracorporeal shock wave in the treatment of patients with PDE5 i anergic erectile dysfunction.In the 13 th and 17 th week of follow-up after the start of Li-ESWT treatment,the results showed that Li-ESWT combined with PDE5 i treatment can significantly improve the erectile function of patients with ED that does not respond to PDE5 i,and Li-ESWT treatment alone can also improve the patient’s erectile function.At least in the short term,its safety and efficacy have been verified,and it can be used as a relatively novel and easier to accept treatment option for patients with PDE5 i non-responsive erectile function.It is worthy of further clinical promotion and application,but it can produce the best clinical effect.The treatment plan and the persistence of its efficacy still need a large number of long-term multi-center controlled studies to clarify.