Clinical Research Of Wuding Yanshi Spray In Patients With Primary Premature Ejaculation In A Randomized Controlled Study

Premature ejaculation is the most common clinical ejaculation dysfunction, and about 1/3 of married men have different degrees of premature ejaculation. Premature ejaculation affect not only the quality of sex life, but also women's sexual satisfaction, and marital consequent.Neuropathology found that premature ejaculation with dorsal penile nerve excitability, especially the excitable feeling of the glans penis than normal nerve, resulting in high sensitivity to stimuli induced by premature ejaculation. Applying for external use through the penis to decrease sensitivity to sexual stimulation, to extend the time to reach orgasm, so as to achieve the purpose of treatment of premature ejaculation.By bushen sejing to treat primary premature ejaculation, Wuding yanshi spray made good clinical efficacy.Objectives:To investigate the efficacy and safety of Wuding yanshi spray in patients with primary premature ejaculation in a randomized, controlled clinical study.Methods:It is accepted the more general diagnostic criteria of premature ejaculation---Guidelines on Male Sexual Dysfunction:Erectile Dysfunction and Premature Ejaculation:Premature ejaculation is a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about few minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.60 patients from andrology clinical of Xiyuan hospital of CATCM from January to December in 2010, were randomized to Wuding yanshi spray and lidocaine hydrochloride gel. Age, severity and duration of two groups were no obvious difference.Patients were instructed to apply the cream on the glans penis,coronary sulcus and frenum 30 min before sexual intercourse. Clinical efficacy was compared with the prolongation of ejaculatory latency improvement of the sexual satisfaction ratio and improvement the score of Premature Ejaculation Diagnostic Tool(PEDT) before and after each treatment.The ejaculatory latency measured by stopwatch.Results:Wuding yanshi spray and lidocaine hydrochloride gel each lost 2 Patients.30 patients in treatment group:the oldest 41 years old, minimum 24 years old, and mean age 31.43±4.51 years.Control group of 30 patients, the maximum age of 40 years old, minimum 23 years old,and mean age 31.20±4.48 years in the control group.30 cases in the treatment group:24 patients with mild, moderate in 5 cases,1 case of severe.Control group of 30 cases, mild in 23 cases, moderate in 6 cases,1 case of severe. In the treatment group,the longest duration of 120 months, the shortest in 3 months, and average 47.93±35.40 months.The longest duration of 109 months,3 months of the shortest in the control group, and average age was 44.37±34.55.(1)The average intravaginal ejaculation latency time(IELT) for comparison:The treatment group before treatment for 1.31±0.51 min, after treatment for 2.80±1.22 min, stopping medicine 4 weeks for 1.33±0.42 min;The control group before treatment for 1.27±0.50 min,after treatment for 1.98±0.72 min, stopping medicine 4 weeks for 1.24±0.52 min. IELT in the after treatment of the two groups, were lengthened obviously(P=0.000<0.05).For the two group,the average IELT for comparison obvious difference after treatment (P=0.003<0.05), the treatment group superior to the control group.(2)The average sexual life satisfaction ratio comparison:the treatment group before treatment for 1.18±0.39, after treatment for 1.36±0.56,4 weeks after treatment for 1.21±0.42; The control group before treatment for 1.18±0.39, treating 4 weeks for 1.39±0.57; stopping medicine 4 weeks for 1.14±0.36. For the treatment group and the control group, the average sexual life satisfaction score have not the significance difference (P=1>0.05)(3)Average Premature Ejaculation Diagnostic Tool score comparison:The treatment group before treatment for 15.18±2.02,after treatment for 10.43±3.67, stopping medicine 4 weeks for 15.25±2.02;The control group before treatment for 15.39±1.91,after treatment for 12.25±4.44,stopping medicine 4 weeks for 15.50±1.91.For the treatment group and the control group, Premature Ejaculation Diagnostic Tool score were shorted obviously after treatment (P=0.000<0.05);but the treatment group was not superior to the control group (P=0.1>0.05)(4) Safety testing:In the treatment group,2 patients had mild allergies, and appeared small red spots; but after washed it,the sexual life back to normal. Control group of lidocaine hydrochloride gel had 1 case of allergy,and back to normal after disabled.The treatment group and the control group were not apparent serious adverse events, indicating that Wuding yanshi spray safe and reliable.Conclusion(1)Wuding yanshi spray can significantly improved the IELT,and reduce the score of Premature Ejaculation Diagnostic Tool(PEDT).(2) Wuding yanshi spray is superior than 2% lidocaine hydrochloride gel.(3) Wuding yanshi spray has no obvious side effects.