| Objective:To investigate the clinical efficacy and safety of transcutaneous neuromuscular electrical stimulation(TNES)combined with low-dose tadalafil Once a day(OAD)on the treatment of mild to moderate erectile dysfunction(ED).Methods:According to the inclusion and exclusion criteria,patients with mild to moderate ED diagnosed in the andrology clinic of Northern Jiangsu People’s Hospital from December 2021 to November 2022 were collected and randomly divided into three groups A,B and C by SPSS random number generator method.Group A was treated with tadalafil 5mg-OAD alone,oral tadalafil for four weeks,once a day,every time5 mg,after dinner.Group B was treated with TNES alone and TNES for four weeks,six times a week,one hour each time.Group C was treated with TNES combined with tadalafil 5mg-OAD,and the usage was group A combined with group B.The general data,history inquiry,male reproductive system examination,serum testosterone and estradiol levels,International Index of Erectile Function(IIEF-5),Erectile Hardness Scale(EHS),Premature Ejaculation Diagnostic Tool(PEDT),Generalized Anxiety Disorder Questionnaire(GAD-7)and Patient Health Questionnaire(PHQ-9)were Perfected before treatment in the three groups.After four weeks of treatment,the subjects of the three groups were followed up for IIEF-5,EHS,PEDT,GAD-7,PHQ-9 assessment scale and the occurrence of adverse reactions during treatment.Statistical analysis was carried out by SPSS23.0.P < 0.05 indicates that the difference is statistically significant.Results:During the period of this study,there were 30 cases in each of groups A,B and C.Group A lost access in 4 cases and dropped out in 2 cases.Group B lost access in 2cases and dropped out in 2 cases.Group C lost access in 3 cases and dropped out in 6cases.A total of 71 patients completed the study during the study period.There were24 patients in group A treated with tadalafil 5mg-OAD,26 patients in group B treated with TNES alone,and 21 patients in group C treated with TNES combined with tadalafil 5mg-OAD.There was no significant difference among the three groups in age,course of disease,body mass index(BMI),serum testosterone and estradiol levels,IIEF-5,EHS,PEDT,GAD-7 and PHQ-9 scores before treatment.Group C significantly improved erectile function in patients with mild to moderate ED,and was significantly better than groups A and B.The IIEF-5 score after treatment was compared between group A and C,and between group C and B with statistical significance(p < 0.05).The IIEF-5 score in group C increased from 11.14±2.59 before treatment to 17.76±3.45 after treatment.After treatment,there was no statistical significance in the efficacy of group B and A(p > 0.05).but the IIEF-5score of group A,B and C after treatment were higher than those before treatment(p <0.05).The total effective rate of IIEF-5 score improvement in group A,B and C was66.67%,69.23% and 85.71% respectively,and there was no significant difference among the three groups(p>0.05).However,the total effective rate of group C was about 20% higher than that of group A and group B.The EHS scores of group A and group C were better after treatment than before(p < 0.05),while,the EHS scores of group B were not different before and after treatment(p>0.05).Group B and C can reduce the score of PEDT and relieve the symptoms of premature ejaculation(PE)in patients with mild to moderate ED.There were significant differences in PEDT scores between group B and group C before and after treatment(p < 0.05).The PEDT score of group B decreased from 8.50 ±2.64 before treatment to 7.04 ±2.97 after treatment.The PEDT score of group C decreased from 8.67 ±2.68 before treatment to 7.25 ±3.00 after treatment.However,there was no significant difference in PEDT scores among groups A,B and C after treatment(p>0.05).Group C can relieve the anxiety of patients with mild to moderate ED,and group C is significantly better than group A.The GAD-7 score after treatment was different between group C and group A(p <0.05).The GAD-7 score of group C decreased from 6.00(1.00,10.50)before treatment to 2.00(0.50,5.00)after treatment.Comparison of GAD-7 scores after treatment between group A and group B was meaningless,nor was comparison between group B and group C(p>0.05).However,the GAD-7 scores of groups A,B and C after treatment were better than those before treatment(p < 0.05).However,there were no differences in PHQ-9 depression scores in groups A,B and C before and after treatment and between groups(p > 0.05).Adverse reactions during treatment were followed up for four weeks.there were 2 cases of adverse reactions in group A,1 case of muscle soreness and 1 case of headache.Follow-up observation,symptom relief.There were no adverse reactions in group B and no adverse reactions in group C.Conclusion:1.TNES combined with tadalafil 5mg-OAD can significantly improve the erectile function of mild to moderate ED patients,and the combination therapy is significantly better than tadalafil 5mg-OAD alone and TNES alone.The combined treatment regimen can be used as a supplementary treatment for the two separate treatment regimens.2.TNES alone and TNES combined with tadalafil 5mg-OAD can reduce the PEDT score of patients with mild to moderate ED and relieve the symptoms of PE in patients with mild to moderate ED.3.TNES combined with tadalafil 5mg-OAD can relieve anxiety in patients with mild to moderate ED.4.TNES has no adverse reaction in the treatment of mild to moderate ED patients,and can be used as a safer treatment. |