premature ejaculation ( pe ) is defined as ejaculation that occurs with minimal stimulation , and which happens before or shortly after penetration , resulting in harassment and anxiety .
pe is the most common sexual dysfunction in men younger than 40 years old , affecting approximately 30% of men .
however , pe is more common in blacks , hispanic males and muslims ( 2 , 3 ) .
there are two types of premature ejaculation , lifelong or primary , and acquired or secondary ( 4 ) .
primary , or lifelong , premature ejaculation is defined as pe that has been a problem since initially beginning coitus . in secondary , or acquired , premature ejaculation the patient has previously had desirable intercourse with subsequent development of pe . measuring the time of ejaculation , usually defined as intravaginal ejaculation latency time ( ielt ) is very important ( 5 ) .
self - estimated and stopwatch - measured ielt accurately determine pe status with 80% sensitivity and 80% specificity and are interchangeable ( 6 ) . in addition , the primary method of evaluation of men with pe is physical examination to diagnose the underlying medical problems , which can be related to pe or other sexual dysfunctions such as chronic disease , endocrinopathy , autonomic neuropathy , peyronie s disease , urethritis and prostatitis . without specific findings from a history or physical examination , conducting laboratory tests or physiological testing are not commonly recommended ( 7 ) .
sometimes the most effective treatment method is medication combined with non - medication treatment ( 8) .
there are several behavior therapies , such as the squeezing and start - stop methods , but many couples find these cumbersome . pharmacologic therapy may include selective serotonin reuptake inhibitor ( ssri ) therapy ( citalopram , sertraline , fluoxetine , dapoxetine or paroxetine ) , phosphodiesterase type 5 ( pde5 ) inhibitor therapy ( tadalafil or sildenafil ) , topical desensitizing agents ( prilocaine or lidocaine ) and other agents ( tramadol or pindolol ) . nowadays , the first choice of treatment for pe is ssris ( 9 ) .
it is worth mentioning that an increase of ielt may begin a few days after initiation of daily ssri intake , and the maximum delay is not observed until after a 1 - 2-week course ( 10 ) .
the therapeutic effect of daily ssris on pe is supported by many double - blind , placebo - controlled and well - designed trials ( 11 , 12 ) .
fluoxetine is inferior to sertraline , while the effect of clomipramine does not significantly differ from fluoxetine and sertraline .
doses of paroxetine , sertraline , fluoxetine and clomipramine were 20 - 40 mg , 25 - 200 mg , 10 - 60 mg and 25 - 50 mg , respectively .
there is little evidence to show that citalopram is less effective than other ssris and that fluvoxamine is not effective ( 13 , 14 ) .
a few days after drug intake , ejaculation delay may occur , but 1 - 2 weeks later , the effect is more obvious because the receptor desensitization takes time ( 15 ) .
diarrhea , fatigue , yawning , perspiration , nausea , dry mouth , drowsiness and vomiting are the usual side effects of ssris . at first , these side effects are usually mild , and they gradually decline after two to three weeks ( 15 ) .
the medication enhances the increase of ielt 6 - 20 times more than before treatment .
although the males are satisfied with the treatment , many of them interrupt it within a year ( 16 ) .
the aim of this study was to compare the efficacy of paroxetine alone and paroxetine plus tadalafil in patients complaining of premature ejaculation .
in 2014 , this quasi - experimental study was performed on 100 consecutive 17 to 49-year - old potent men with premature ejaculation and without any clear organic disease .
all married patients with lifelong pe and ielt shorter than 1.5 minutes were included in the study .
additional exclusion criteria included patients with erectile dysfunction ( ed ) , prostatitis , severe drug complications and poor control over ejaculation .
the study participants were equally classified into two groups , a and b , using a computer - generated random tabulation list .
this research was approved by the ethical committee of babol university of medical sciences and informed consent was obtained from all patients .
the assessment before treatment contained a history , physical examination , u / c and stamey test to exclude genital tract infection .
all patients self - completed the international index of erectile function ( iief ) questionnaire .
group a included 50 patients who received 10 mg daily doses of paroxetine four hours before planned sexual activity for 30 days , and if it was needed the dose was increased to 20 mg .
group b included 50 patients who received daily doses of 10 mg tadalafil one hour before intercourse , plus 10 mg paroxetine four hours before planned sexual activity for 30 days .
the primary outcome was ielt and secondary outcomes were intercourse satisfaction in men and drug side effects .
other variables , such as age and number of intercourses per week , were recorded for all patients .
patients were followed - up with at three and six months after beginning therapy to assess primary and secondary outcomes .
the data were analyzed using spss version 15 statistical software , and the independent t - test with intention to treat method was used . a value of p < 0.05 was considered as significant .
the mean age and number of intercourses per week in both groups are shown in table 1 .
mean ejaculatory latency time at the 3-month follow up in groups a and b were 4.5  1.5 and 5  2.4 minutes , respectively ( p = 0.285 ) , and at the 6-month follow up were , 4.8  1 and 5.3  2 minutes , respectively ( p = 0.278 ) ( figure 1 ) .
values are expressed as mean  sd . the 3-month and 6-month mean intercourse satisfaction domain values of the iief were 9 , 11 and 11 , and 9 , 11 and 14 in groups a and b , respectively .
there was no significant difference between groups a and b regarding intercourse satisfaction ( p > 0.05 ) .
the side effects in group a included gastrointestinal upset and/or nausea in 5 ( 10% ) patients , headache in 4 ( 8% ) patients , decreased libido in 2 ( 4% ) patients and delayed ejaculation in 1 ( 2% ) patient .
the side effects in group b included headache in 11 ( 22% ) patients , flushing in 8 ( 16% ) patients and gastrointestinal upset and/or nausea in 4 ( 8% ) patients .
flushing episodes were more significant in group b ( p = 0.000 ) than in group a. other side effects did not show a significant difference between the two groups .
recently , some studies have investigated the therapeutic role of phosphodiesterase 5 ( pde5 ) inhibitors in pe .
pde5s may decrease performance anxiety because of improved erections and may downregulate the erectile limen to a lower state of arousal , so that greater arousal is necessary to reach the ejaculation limen ; however , many of the mechanisms involved are speculative ( 17 - 19 ) .
therefore , the aim of this study was to compare the efficacy of paroxetine alone and paroxetine combined with tadalafil in patients complaining of premature ejaculation .
the results of the present study show that ielt at the 3-month and 6-month follow up , in the group with combination therapy of paroxetine and tadalafil , was higher than that of the paroxetine group , but this difference was not significant .
previously , sildenafil was compared with placebo in a well - designed , randomized , double - blind , placebo - controlled study ( 20 ) . in this study , sildenafil enhanced the perception of ejaculatory control , overall sexual satisfaction and confidence , reduced anxiety and the demand time to reach a second erection after ejaculation , though ielt was not significantly increased . in another randomized , double - blind , placebo - controlled study ,
the combination of sildenafil ( 50 mg before intercourse ) with lidocaine or prilocaine had the same effect , but showed no superiority to placebo ( ielt was not considered ) ( 21 ) .
one double - blind randomized study showed that sildenafil improved ielt and satisfaction and reduced anxiety in comparison with several ssris and the pause - squeeze technique .
sildenafil , clomipramine , sertraline , paroxetine and the pause - squeeze technique improved the baseline ielt from 1 minute to 15 minutes , 4 minutes , 3 minutes , 4 minutes and 3 minutes , respectively ( 22 ) .
various open - label studies have indicated that sildenafil combined with an ssri is superior to ssri monotherapy .
in contrast to paroxetine alone , sildenafil plus paroxetine improved ielt and satisfaction ( 23 ) .
sildenafil plus sertraline , in comparison to sertraline alone , significantly improved ielt and satisfaction ( 24 ) .
the combination of sildenafil with paroxetine and psychological and behavioral counseling in patients who had failed with other treatments considerably improved ielt and satisfaction ( 25 ) .
finally , behavioral therapy alone compared to sildenafil plus behavioral therapy was significantly inferior in the improvement of ielt and satisfaction ( 26 ) .
other pde5 inhibitors ( tadalafil and vardenafil ) have limited data on their effect in pe ( 19 , 27 ) . in the current study ,
pe was treated by paroxetine alone and in combination with tadalafil and showed that ielt increases with combination therapy . in summary ,
the role of pde5 inhibitors is not established in pe patients without ed , and there are few double - blind placebo controlled studies .
paroxetine is more effective than sertraline , clomipramine and fluoxetine ( 13 , 14 ) .
the current study is limited because it was not blind and this could affect the result .
nevertheless , the results show that paroxetine plus tadalafil provides better results in terms of ielt and intercourse satisfaction , versus paroxetine alone in potent patients with premature ejaculation ; however , combined treatment mildly increases drug side effects .
 background : several recent studies have investigated the therapeutic role of phosphodiesterase type 5 ( pde5 ) inhibitors in premature ejaculation ( pe ) used in the treatment of erectile dysfunction.objectives:in the present research , the efficacy of paroxetine alone and paroxetine plus tadalafil was compared in patients referred because of premature ejaculation.patients and methods : this quasi - experimental study was performed on 100 consecutive 17 to 49-year - old potent men with premature ejaculation and without any clear organic disease . 
 all patients had lifelong pe with an intravaginal ejaculation latency time ( ielt ) shorter than 1.5 minutes . 
 informed consent was obtained from all patients who were randomly divided into two groups using a computer - generated random tabulation list . in group 
 a , patients received 10 mg paroxetine daily , in addition to four hours before planned sexual activity . in group 
 b , 10 mg paroxetine was taken daily , plus 10 mg tadalafil one hour before planned sexual activity . 
 the duration of the intervention was six months and patients were evaluated for ielt three and six months after the beginning of therapy.results:the mean age of patients in groups a and b were 33  9.6 and 31.2  9.3 years , respectively ( p = 0.368 ) . 
 the mean number of intercourses were 1.08  0.6 and 1.12  0.6 per week in groups a and b , respectively ( p = 0.791 ) . 
 mean ielt at the 3-month follow up in groups a and b was 4.5  1.5 and 5  2.4 minutes , respectively ( p = 0.285 ) and at the 6-month follow up was 4.8  1 and 5.3  2 minutes , respectively ( p = 0.278).conclusions : the results of the study show that tadalafil can increase the mean ielt and can be used for treatment of premature ejaculation in combination with paroxetine . 
1. Background
2. Objectives
3. Patients and Methods
4. Results
5. Discussion