| Background:Premature ejaculation(PE)is one of the most common male sexual dysfunction diseases.The prevalence of PE in the 18-65 year old male population rang from 20% to 30% according to the cross-sectional survey results.PE has serious adverse effects on couples' relationship,patients' self-evaluation and quality of life.Primary premature ejaculation(PPE)refers to premature ejaculation from the beginning of sexual life,and the global prevalence can be 2.3%-3.2%.The diagnosis and efficacy assessment mainly based on objective indicator such as intravaginal ejaculatory latency time(IELT)combined with questionnaires or other subjective index comprehensive evaluation.Although both of estimated intravaginal ejaculatory latency time(eIELT)and stopwatch-measured intravaginal ejaculatory latency time(sIELT)were recommended,it is still controversial whether they can be substituted for each other in the application.The traditional view is that PPE is a neurosis of psychosomatic disorder or behavioral disorder related to self-acquisition.Further research considered that PPE is a disease associated with somatic neurological dysfunction and neurological functional disorder.With the development of the research on the mechanism of 5-hydroxytryptamine(5-HT)neurotransmitter transmission disorder in the central nervous system,selective serotonin reuptake inhibitors(SSRIs)have opened a new chapter for the treatment of PPE and have become the first-line treatment method recommended by the current international guidelines for the diagnosis and treatment of premature ejaculation.SSRIs include long-acting drugs such as fluoxetine,sertraline,paroxetine,etc,and short-acting,on-demand drugs such as dapoxetine.All of them have a certain percentage of adverse reactions and withdrawal reactions.Topical anesthetics such as lidocaine cream are also the first-line drugs for the treatment of premature ejaculation,but may cause adverse reactions such as sensation decreasing of the penis and vagina and decreasing of erection hardness.Psychological and behavioral therapies are not ideal,and they are only used as adjuvant therapies.Surgical treatment such as selective penile dorsal neurectomy is controversial,and its effect has not been recognized by the most andrologists and there are risks of sensory numbness of the glans and erectile dysfunction.In conclusion,all the current treatment choices applied to PPE have obvious defects,such as severe side effects,obvious withdrawal reaction,inconvenient application,poor effect,low patients acceptance,poor compliance and so on.Therefore,it is urgent to seek new clinical treatment methods that are safe,stable,convenient application and long-lasting effect.Objective:To evaluate the feasibility to substitute sIELT by eIELT in PE through Meta analysis and provide evidence for the selection of appropriate evaluation tools for the diagnosis and treatment of PE.At the same time to evaluate the efficacy and safety of injection of botulinum toxin-A into the bulbospongiosus muscle in the treatment of PPE by prospective clinical study.Methods:1.Literatures on the measurement of sIELT and eIELT control studies were retrieved from the PubMed,Embase,Cochrane Library,CNKI Database,Wanfang Database and SinoMed database,and Meta analysis was conducted on relevant research data after literature screening.The differences between the sIELT and eIELT in the diagnosis and treatment of PE were analyzed and evaluated.2.A total of 70 patients with PPE who admitted to the outpatient department from September to December 2017 were included in our study according to the inclusion and exclusion criteria and randomly divided into two groups.Thirty-five patients in the treatment group received injection of botulinum toxin-A 100 U into bilateral bulbospongiosus muscle,while 35 patients in the control group received injection of normal saline into bilateral bulbospongiosus muscle.The changes of IELT and various PE-related scales were compared on the day of the injection and the 4th week after the injection,and adverse reactions were recorded in detail.Results:1.A total of 894 related literatures were retrieved and 5 literatures met the inclusion criteria.The Meta-analysis results showed that there were difference between the two types of IELT in the total males(SMD=0.18,95%CI:0.01~0.36,P=0.04).There were no difference between the two types of IELT in PE patients(SMD=0.09,95%CI:-0.22~0.40,P=0.57).There were significant difference between the two types of IELT in non-PE patients(SMD=0.33,95%CI 0.19-0.46,P<0.00001).2.Sixty-nine patients(Including 34 patients in the treatment group and 35 patients in the control group)accomplished this study and obtained complete data according to the requirements.The effective rate was 47.06%(16/34)in the treatment group and no improvement in the control group.After treatment for 4 weeks,the IELT of the treatment group have increased from [(0.74+0.27)min] to [(2.35+1.83)min](P<0.01)which was significantly different from that of the control group after treatment [(0.79±0.21)min](P<0.01).Premature ejaculation profile(PEP)scale about the ejaculation control,sexual satisfaction,PE-related pain and distress,PE-induced difficult relationship with partners of the treatment group were improved after treatment,the scores(1.21±1.04)(1.32±1.01)(2.12±1.01)(1.38±0.70)were significantly different compared with those before treatment in treatment group(P<0.05)as well as those of the control group after treatment(P<0.05)respectively.The satisfaction degree of sexual life of partners after injection in the treatment group was significantly improved.The score(1.18±1.00)was significantly different from the score of treatment group before injection(0.62±0.60)as well as that of the control group after treatment(0.57±0.50)(P<0.05).There was no significant difference in male sexual health questionnair ejaculatory dysfunction(MSHQ-EjD),hospital anxiety and depression scale(HADS)scores between the two groups before and after treatment.Adverse reactions were observed in 6 cases in the treatment group(17.65%),including 4 cases of lower erectile hardness and 2 cases of having sense of incomplete urination.Each of the adverse reactions appeared from the 3-4 days after injection,and relieved after 3 weeks without any treatment.Conclusion:1.Meta analysis results showed that in the process of diagnosis and evaluation of PE,sIELT can be substitute by eIELT as an evaluation tool for the diagnosis and treatment of PE.But the eIELT result can be longer than the sIELT for normal males and direct replacement is not recommended for the evaluation of the non-PE people.2.Injection of botulinum toxin-A into the bulbospongiosus muscle could be a new way for the treatment of PPE.Preliminary clinical study has shown that the single dose treatment has longer term effects and relatively higher safety,and it can be used as an alternative treatment of PPE.However,this method is still in the early exploration stage,and its application advantages and optimal injection dose still need further study. |
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