Correlates to the clinical diagnosis of premature ejaculation: results from a large observational study of men and their partners

PURPOSE: A recent observational study characterized intravaginal ejaculatory latency time and single item patient reported outcome measures in a large population of males with and without premature ejaculation, as well as their female partners. In the current analysis we assessed the relative influence of those measures in identifying premature ejaculation as diagnosed by the clinician. MATERIALS AND METHODS: Data were from a 4-week, multicenter, observational study of men with (207) and without (1,380) premature ejaculation (diagnosed using The Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision criteria), as well as their female partners. Estimated and measured intravaginal ejaculatory latency time, age, and responses to single item (control over ejaculation, personal distress, satisfaction with sexual intercourse and interpersonal difficulty) and multiple item (male and female Golombok-Rust Inventory of Sexual Satisfaction, male Self-Esteem and Relationship questionnaire, and Short Form 36) measures were evaluated with stepwise logistic regression analysis. RESULTS: Self-estimated and stopwatch measured intravaginal ejaculatory latency time were interchangeable, correctly assigning premature ejaculation status with 80% sensitivity and 80% specificity, increasing to 80% sensitivity and 96% specificity when combined with single item patient reported outcomes. Subject reported control over ejaculation and personal distress most strongly indicated premature ejaculation status. Partner personal distress was more influential in determining premature ejaculation status than estimated or measured intravaginal ejaculatory latency time, and single item measures were more influential than multiple item measures. Age was not influential in assigning premature ejaculation status. CONCLUSIONS: Neither self-estimated nor stopwatch measured intravaginal ejaculatory latency time alone was optimal for assigning premature ejaculation status. Subject and partner responses to single item measures, particularly control over ejaculation and personal distress, were important. Results suggest that a combination of estimated intravaginal ejaculatory latency time and the 4 single item patient reported outcome measures can adequately identify premature ejaculation status.     

Premature ejaculation: results from a five-country European observational study

OBJECTIVES: To characterize premature ejaculation (PE) in five European countries using intravaginal ejaculatory latency time (IELT) and the Premature Ejaculation Profile (PEP). METHODS: This 8-wk, multicenter, observational study enrolled men >or=18 yr of age and their female partners. Clinicians diagnosed PE using the DSM-IV-TR criteria and at least moderate, subject-reported, ejaculation-related personal distress or interpersonal difficulty. The PEP was administered at baseline and weeks 4 and 8. Partners measured IELT; the average stopwatch-measured IELT for each 4-wk period was calculated and compared with the man's screening-estimated IELT. Relationships between individual PEP measures and IELT were assessed with path analysis. RESULTS: PE was diagnosed in 201 of 1115 men. Findings were similar to those in a similarly conducted US study. Mean IELT was lower in the PE versus the non-PE group (3.3 vs. 10.0min, respectively), but substantial overlap was observed. Men with PE and their partners reported significantly worse control over ejaculation, ejaculation-related personal distress, satisfaction with sexual intercourse, and ejaculation-related interpersonal difficulty than men without PE and their partners. Path analysis showed that perceived control over ejaculation had a significant effect on ejaculation-related personal distress and satisfaction with sexual intercourse; IELT had an effect on control over ejaculation, no direct effect on satisfaction with sexual intercourse, and a small direct effect on ejaculation-related personal distress. CONCLUSIONS: No major cultural differences existed between EU and US men with and without PE and their female partners. These results emphasize the importance of the PEP measures, especially perceived control over ejaculation, in characterizing PE.     

PSD502 improves ejaculatory latency,control and sexual satisfaction when applied topically 5 min before intercourse in men with premature ejaculation: results of a phase III,multicentre, double‐blind,placebo‐controlled study

OBJECTIVES

To determine the effect of PSD502 applied topically 5 min before intercourse on the Index of Premature Ejaculation (IPE) and intravaginal ejaculatory latency time (IELT) of men with lifelong premature ejaculation (PE) defined according to the International Society of Sexual Medicine (ISSM) definition; secondary objectives were to evaluate the safety and tolerability of PSD502 in patients with PE, and their sexual partners.

PATIENTS AND METHODS

Men aged >18 years, in stable heterosexual, monogamous relationships, and with lifelong PE diagnosed according to both the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision) criteria and the ISSM definition, consented (together with their partners) to enter the baseline period of the study. Patients who documented an IELT of ≤1 min with two or more of the first three sexual encounters during the 4‐week baseline period were randomized, in a 2:1 ratio, to receive double‐blind treatment with PSD502 (three actuations of spray each containing 7.5 mg lidocaine and 2.5 mg prilocaine applied 5 min before intercourse) or placebo for 3 months. Patients completed IPE and Premature Ejaculation Profile (PEP) questionnaires at entry and at monthly clinic visits, and recorded stopwatch‐timed IELT during each sexual encounter. Patients rated the quality of their orgasms on a 5‐point scale at baseline and at the end of the treatment period, and rated the study medication on a 4‐point scale. Safety was assessed by collecting adverse event data.

RESULTS

In all, 300 men with PE were randomized from 31 centres in Europe. The geometric mean (range) IELT over the 3‐month treatment period increased from a baseline of 0.6 min in both groups to 3.8 (0.3–57.8) and 1.1 (0–15.0) min in the PSD502 and placebo groups, respectively. Adjusting for treatment‐group imbalances, this represents a 6.3‐fold and 1.7‐fold increase in adjusted geometric means. There were significantly greater increases in the scores for the IPE domains of ejaculatory control and sexual satisfaction in the PSD502 group than in the placebo group, with a mean (sem ) 7.0 (0.59)‐point difference between treatments in change from baseline in the IPE domain for ejaculatory control and a 5.9 (0.57)‐ point difference in change from baseline in the IPE domain for sexual satisfaction (both P < 0.001). This was supported by improvements in all secondary endpoints. At the end of the treatment period 66% of patients rated PSD502 as ‘good’ or ‘excellent’. PSD502 was well tolerated and no systemic adverse events were reported. Localized treatment‐related adverse events were reported by 2.6% and 3.1% of patients and partners, respectively.

CONCLUSION

PSD502 applied topically 5 min before intercourse improved ejaculatory latency and significantly improved ejaculatory control and sexual satisfaction, factors relevant for acceptance of a PE treatment by both patient/physician and regulatory authorities. PSD502 was well tolerated by both patients and partners, with no systemic side‐effects and a low incidence of localized effects, and was rated favourably by most users. PSD502 therefore appears to offer significant advantages over other therapies in development for the treatment of PE.     

Further evidence of the reliability and validity of the premature ejaculation diagnostic tool

This study details the further validation of the Premature Ejaculation Diagnostic Tool (PEDT), a five-item tool, developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, revised version 4 (DSM-IV-TR), criteria in diagnosing presence or absence of premature ejaculation (PE). A total of 102 men completed the PEDT and were then interviewed by one of the seven clinical experts, who made a diagnosis of presence or absence of PE. The diagnoses from these two methods were compared to assess the convergent validity of PEDT. Retest reliability was also assessed, by men completing the PEDT a second time, approximately 2 weeks after the first administration. The level of agreement between clinical expert and PEDT diagnoses was very high (kappa-statistic=0.80 (95% CI=0.68-0.92)), and retest reliability was very good - Intraclass correlation coefficient=0.88. In summary, the PEDT is extensively validated, self-report measure that can systematically assess DSM-IV-TR criteria to provide accurate diagnoses of PE/no-PE.     

The efficacy of citalopram in the treatment of premature ejaculation: a placebo-controlled study

BACKGROUND: Despite the limited number of available study comparing of their efficacy, selective serotonin re-uptake inhibitors (SSRI) have been thought to have beneficial effects for the patients with premature ejaculation. In the present study, we decided to examine the efficacy of citalopram, an SSRI, in the treatment of premature ejaculation. METHOD: The study was consisted of 26 married patients diagnosed with premature ejaculation according to Diagnostic and Statistical Manual of Mental Disorders Third Revised Version (DSM-III-R). The patients were randomly assigned to two groups, citalopram (group I) and placebo (group II), each consisting of 13 patients. The effects of drug on the ejaculatory function were assessed by the intravaginal ejaculation latency time. Additionally, all patients were screened by using Clinical Global Impression-Improvement Scale (CGI-I) and Yonsei Sexual Function Inventory-II (YSFI-II). RESULTS: The increase in the intravaginal ejaculation latency time in the citalopram group was statistically significant than that of placebo group. In addition, with respect to the subscales of the YSFI-II scale, similar overall significant improvements were seen in the patients given citalopram compared to those given placebo. Of group I patients, five (38.5%) were considered as 'very much improved' and four (30.8%) 'much improved' by CGI-I and only one of group II patients (7.7%) showed 'much improved'. CONCLUSION: The patients treated with citalopram showed significantly greater improvement compared to the patients receiving placebo.     

The relationship between premature ejaculation and the timing of pre-adult circumcision

We aimed to investigate the relationship between premature ejaculation and the age when men had been circumcised before adulthood. A total of 2,768 sexually active male patients aged between 18 and 65 years were included in this study. A multicentre study was conducted prospectively with the participation of 20 centres. A survey consisting of 12 questions prepared by the researchers, as well as the validated Turkish versions of the five-item Premature Ejaculation Diagnostic Tool, was administered to all participants. The study included 1,603 participants who met the inclusion criteria. There was no significant difference in the Premature Ejaculation Diagnostic Tool and self-reported ejaculation time between the participants who had been circumcised at different ages during childhood. Remembering circumcision experience with fear or anxiety did not increase the risk of sexual dysfunction compared to the participants who described their experience with happiness or with no particular emotion. There was no significant difference in Premature Ejaculation Diagnostic Tool scores or the self-reported ejaculation time of the participants circumcised at different ages. The age of childhood circumcision, having a fearful or anxious circumcision experience, does not affect the risk of premature ejaculation in adult life.     

男性性功能障碍相关问卷的应用进展

由于男性性功能障碍发病率的升高,临床医生越来越需要准确、高效的问卷来评估治疗效果和满意度,并帮助患者达到满意的治疗结果。为此,本文总结了一些关于男性性功能障碍的常用问卷,包括勃起功能国际问卷、勃起硬度分级、勃起质量量表、勃起功能障碍治疗满意度调查表、治疗满意度量表、自尊心及性关系问卷、早泄评估表、早泄诊断工具、早泄指数量表、阿拉伯早泄指数量表、老年男性症状量表、中老年男性雄激素缺乏自测表以及迟发型(迟发性性腺功能减退)睾丸功能减退症状调查表,并对它们的临床应用进行了综述。     

The etiology and management of premature ejaculation

Premature ejaculation (PE) is a common male sexual disorder. Normative data suggest that men with an intravaginal ejaculatory latency time of less than 1 min have 'definite' premature ejaculation, while men with intravaginal ejaculatory latency times of between 1 and 1.5 min have 'probable' premature ejaculation. Although there is insufficient empirical evidence to identify the etiology of PE, there is correlational evidence to suggest that men with PE have high levels of sexual anxiety and altered sensitivity of central 5-hydroxytryptamine receptors. Pharmacological modulation of the ejaculatory threshold using daily or on-demand selective serotonin reuptake inhibitors offers patients a high likelihood of achieving improved ejaculatory control within a few days of initiating treatment, leads to improvements in sexual desire and other sexual domains, and is well tolerated.     

Seminal plasma magnesium and premature ejaculation: a case-control study

OBJECTIVE: To determine the relationship between premature ejaculation (PE) and serum and seminal plasma magnesium levels, in a case-control study. PATIENTS AND METHODS: Thirty-eight patients referred to the authors' urology outpatient clinic were evaluated in two groups; cases comprised 19 men complaining of PE, defined using the Diagnostic and Statistical Manual of Mental Disorders IV criteria and an intravaginal ejaculatory latency time (IELT) of <1 min, and a control group of 19 married men with a normal IELT. All men had a history taken, a systemic physical examination and laboratory studies. After organic and psychogenic disorders were excluded, the 19 patients were included in the study. Seminal plasma and serum magnesium levels were determined using atomic absorption spectrophotometry. RESULTS: The mean (sd) plasma magnesium level was 94.7 (10.9) mg/L in the cases and 116.7 (11.6) mg/L in the controls. There was a significant relationship between seminal plasma magnesium, but not the plasma level, and PE (P < 0.001 and 0.597 respectively). CONCLUSION: PE is significantly related with a lower level of seminal plasma magnesium. The pathological physiology of this relationship requires more investigation.     

Relation between blood vitamin B12 levels with premature ejaculation: case–control study

The aim of this study was to investigate whether vitamin B12 levels are associated with premature ejaculation (PE). A total of 109 subjects (56 PE and 53 controls) were included in this study. PE was defined as self‐reported intravaginal ejaculatory latency time (IELT) based on the Diagnostic and Statistical Manual of Mental Disorders IV criteria and those who had had an IELT of <2 min was considered as PE. All participants were evaluated using premature ejaculation diagnostic tool (PEDT), International Index of Erectile Function (IIEF) and Beck Depression Inventory (BDI). The vitamin 12 levels were measured in all subjects. The mean age between the PE and controls was comparable (p = .084). Mean IIEF and BDI scores between the two groups did not statistically differ. The mean IELT values in the PE group were significantly lower than in the control group (p < .0001). PE patients reported significantly lower vitamin B12 levels compared with the controls (213.14 vs. 265.89 ng ml^?1; p < .001). The ROC analysis showed a significant correlation between the diagnosis of PE and lower vitamin B12 levels. This study has demonstrated that lower vitamin B12 levels are associated with the presence of PE. This work also shows a strong correlation between vitamin B12 levels and the PEDT scores as well as the IELT values.     

Serum leptin levels in patients with premature ejaculation

Leptin is a fat cell-derived hormone signaling the hypothalamus about food intake, the regulation of weight, and sexual behavior. The inhibitory effect of serotonin on libido, ejaculation, and orgasm is well documented. There is an interaction between leptinergic and serotonergic systems in the central nervous system. This study was conducted to evaluate serum leptin levels of the patients with premature ejaculation. The study group consisted of 15 patients with premature ejaculation according to Diagnostic and Statistical Manual of Mental Disorders, Third Revised Version (DSM-III-R) and 15 healthy controls. The fasting serum leptin levels were measured. Significantly high serum leptin levels in the patients were found after body mass index or age adjustment. The intravaginal ejaculation latency time negatively correlated with leptin levels in both patient and control groups. In addition, there was a positive correlation between leptin levels and the duration of illness. It would appear that leptin may be associated with premature ejaculation.     

Premature ejaculation and stress

Recent findings indicate that men with premature ejaculation report more frequent sexual problems associated with increased anxiety and interpersonal difficulties. Bearing this in mind, the neuroendocrine changes were examined in men with premature ejaculation and compared to other indicators of stressful experiences to see whether there can be any correlation which could indicate how these factors may contribute to the aetiology of premature ejaculation. Our study comprised 60 male outpatients diagnosed as having secondary premature ejaculation. Clinical examinations were focused on biochemical analysis of cortisol and psychometric scoring using a diagnostic tool for premature ejaculation, traumatic stress and somatoform dissociation. The control group consisted of a 60 healthy men. The results showed significant Spearman correlations of the Premature Ejaculation Diagnostic Tool score with Trauma Symptom Checklist score (R = .86), cortisol level (R = .47) and Somatoform Dissociation Questionnaire score (R = .61). In the control group, the results did not reach statistical significance. Spearman correlations of the Premature Ejaculation Diagnostic Tool score with Trauma symptoms checklist score was (R = .21), cortisol (R = .27) and with Somatoform dissociation questionnaire score (R = .25). These results represent the first reported findings documenting the relationship of traumatic stress indicators with the experience of secondary premature ejaculation and cortisol levels.     

Serum leptin levels in patients with premature ejaculation before and after citalopram treatment

OBJECTIVE: To evaluate serum leptin levels (an adipocyte hormone involved in the suppression of appetite) in patients with premature ejaculation before and after treatment with citalopram, a selective serotonin reuptake inhibitor, with the hypothesis that leptin levels might become normal during this treatment. PATIENTS AND METHODS: The inhibitory effect of serotonin on libido, ejaculation and orgasm is well documented. Although there is no direct evidence of an association involving brain pathways which are related to sexual behaviour, there is an interaction between leptinergic and serotonergic systems. In a previous study serum leptin levels were high in patients with premature ejaculation. The present study comprised 30 patients with premature ejaculation according to the Diagnostic and Statistical Manual of Mental Disorders Third Revised Version. Fifteen patients (group I) were randomly assigned to 8 weeks of citalopram treatment and the remainder (15, group II) received no therapy. The patients were asked to determine the average intravaginal ejaculation latency time, and their fasting serum leptin levels were measured at baseline and after 8 weeks. RESULTS: There was no significant difference in the mean intravaginal ejaculation latency time between the groups at baseline; it increased after 8 weeks of treatment with citalopram in group I, to a mean (sd) of 209 (72.1) s, but not in group II. No difference was detected in leptin levels between the groups at baseline, but at 8 weeks they were lower in group I. CONCLUSION: As hypothesized, leptin levels decreased in patients with premature ejaculation after treatment with citalopram, and this decrease seemed to be linked to the therapeutic effect. Further experimental studies are needed.     

New approach to patients with premature ejaculation: Do social cognition and attachment profiles play a role in premature ejaculation?

Premature ejaculation is the most prevalent male sexual dysfunction and causes significant individual and relational distress in subjects. This study aimed to investigate the underlying psychopathologies of premature ejaculation using theory of mind, empathy and attachment parameters and included 91 participants: 46 with lifelong premature ejaculation and 45 without any ejaculatory complaints. Arabic index of premature ejaculation and stopwatch intravaginal ejaculatory latency times were recorded from all subjects in order to evaluate ejaculatory function. We used reading mind in the eyes, empathy quotient and experiences in close relationships-revised tasks to evaluate social cognitive and attachment profiles of the participants. We compared differences between groups in terms of task performances and symptom severity. Premature ejaculation patients showed significantly low levels of theory of mind abilities as well as empathic skills compared to controls. Although groups did not differ significantly in means of attachment avoidance parameters, premature ejaculation patients had significantly higher levels of attachment anxiety parameters. There was no correlation between symptom severity and social cognition and attachment scores in premature ejaculation patients. These results suggest that patients with premature ejaculations may suffer from significant social cognitive deficits and have anxious but not avoidant pattern of attachment. These results may implicate insights in terms of pharmacological and psychotherapeutic treatments of premature ejaculation.     

Treatment benefit of dapoxetine for premature ejaculation: results from a placebo‐controlled phase III trial

OBJECTIVE

To evaluate the overall treatment benefit of dapoxetine for premature ejaculation (PE), with specific emphasis on improvements in personal distress and interpersonal difficulty related to ejaculation. Although these factors are key elements of numerous sets of diagnostic criteria for PE, they have rarely been evaluated as outcome measures in clinical trials.

PATIENTS AND METHODS

In this randomized, double‐blind, placebo‐controlled, phase III trial we enrolled men aged ≥18 years, from the USA and Canada, who had a Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision, diagnosis of PE (1238 men). Men were randomized to receive placebo or dapoxetine 60 mg as needed or once daily for 9 weeks. The once‐daily treatment arm was included for analysis of withdrawal symptoms (primary endpoint; presented elsewhere). Patients completed the Premature Ejaculation Profile (PEP) on day 1 (before dosing), and on days 28 and 63 (or study endpoint), which comprised the outcome measures for perceived control over ejaculation, satisfaction with sexual intercourse, and personal distress and interpersonal difficulty related to ejaculation. The patient‐reported global impression of change in PE was reported on day 63 (or study endpoint). Treatment benefit measures included the composite criteria of at least a two‐category increase in perceived control over ejaculation and at least a one‐category decrease in personal distress related to ejaculation from baseline at study endpoint.

RESULTS

At baseline, ≈5% of patients in any treatment group reported ‘not at all’ or ‘a little bit’ of personal distress related to ejaculation, which increased to 54.3% of those receiving dapoxetine (vs 35.3% with placebo; P < 0.001). Similarly, 43.0% and 40.9% of men in the placebo and dapoxetine groups, respectively, reported ‘not at all’ or ‘a little bit’ of interpersonal difficulty related to ejaculation at baseline, which increased to 76.8% and 64.2% of those with dapoxetine and placebo, respectively (P < 0.001). The percentage of men who achieved the composite criteria with dapoxetine ‘as needed’ was 47.6%, vs 21.7% with placebo (difference from placebo, 25.9%; P < 0.001). The distribution of responses for the PEP among men who achieved the composite criteria was similar to that reported for men without PE in a previous observational study in the USA. The most common adverse events were nausea, dizziness, headache, diarrhoea and insomnia, which were more common with dapoxetine than with placebo.

CONCLUSION

Dapoxetine reduced the personal distress and interpersonal difficulty associated with PE, and was associated with patient‐reported improvements in their condition. The percentage of patients who achieved a composite of a two‐category or greater increase in perceived control over ejaculation and a one‐category or greater decrease in personal distress related to ejaculation was substantially greater than with placebo, as were all outcome measures.     

The relationship between female sexual function index domains and premature ejaculation

Purpose

The aim of this prospective, observational study was to investigate the relationship between premature ejaculation (PE) and female sexual response cycle, using the female sexual function index (FSFI). The FSFI evaluates female sexual function in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.

Methods

All men were considered to have PE if they fulfilled the criteria of the second Ad Hoc International Society for Sexual Medicine (ISSM) Committee. All men were also assessed by the Premature Ejaculation Diagnostic Tool (PEDT) and intravaginal ejaculatory latency time (IELT) using stopwatch which was held by the partner. All women completed the FSFI.

Results

A total of 181 couples who had regular sexual intercourse with one partner for the past 6 months were enrolled the study. By the definition of ISSM Committee, there were 117 men with PE and 64 men without PE. Partners of men with PE had significantly lower total FSFI scores than did partners of men without PE (21.8?±?3.5 for PE and 26.4?±?3.1 for non-PE, p?<?0.001). Moreover, all the domains of the FSFI scoring system were separately associated with PE. According to the mean FSFI scores, the 48.43% of women had sexual dysfunction in the non-PE group, and all women had sexual dysfunction in PE group.

Conclusion

PE is associated with female sexual dysfunction and all of the female sexual dysfunction domains, as determined by FSFI scores.

     

Escitalopram treatment for premature ejaculation has a negative effect on semen parameters

The aim of this study was to determine the impact of long-term escitalopram treatment on semen parameters of patients with lifelong premature ejaculation (PE). Between November 2008 and January 2010, patients admitted to urology outpatient clinic with a self-reported complaint of PE were evaluated. Medical and sexual history of patients were recorded and patients with lifelong PE (a total of 25 patients) who met the International Society of Sexual Medicine definition were asked to record their intravaginal ejaculatory latency time (IELT) for 1 month, complete Premature Ejaculation Diagnostic Tool (PEDT) questionnaire and give semen samples. Afterwards, patients received 10 mg escitalopram daily for 12 weeks and were invited for control visits at first and third month of treatment. During control visits, PEDT was administered again whereas IELTs were recorded and semen samples were re-examined. PEDT scores, arithmetic means of IELTs and results of semen analyses, which were recorded at baseline, first and third month were compared. At the third month of treatment, a significant increase in mean IELTs and a significant decrease in PEDT scores were detected. However there was a significant decrease in sperm concentration, motility and morphology when compared with the baseline semen measures. Daily escitalopram treatment effects the semen parameters of patients with lifelong PE. Further investigations with larger series are needed to see whether other serotonin reuptake inhibitors have similar side effects and to expose the exact mechanism underlying it. Different treatment modalities should be suggested to patients who desire fertility.     

The frequency of sexual dysfunctions in male partners of women with vaginismus in a Turkish sample

The aim of this investigation is to determine the sexual history traits, sexual satisfaction level and frequency of sexual dysfunctions in men whose partners have vaginismus. The study included 32 male partners of vaginismic patients, who presented at a psychiatry department. Subjects were evaluated by a semi-structured questionnaire. The questionnaire was developed by researchers for assessing sexually dysfunctional patients and included detailed questions with regard to socio-demographic variables, general medical and sexual history. All participants also received the Golombok Rust Inventory of Sexual Satisfaction (GRISS). According to DSM-IV-TR criteria, 65.6% of the investigated males were diagnosed with one or more sexual dysfunctions. The most common problem was premature ejaculation (50%) and the second one was erectile dysfunction (28%). The transformed GRISS subscale scores provided similar data. It is concluded that the assessment of sexual functions of males who have vaginismic partners should be an integral part of the management procedure of vaginismus for optimal outcome.     

Impact of varicocelectomy on premature ejaculation in varicocele patients

In a prospective manner, we studied the effect of varicocelectomy on premature ejaculation and testicular hormonal function in patients with varicocele. Microsurgical subinguinal varicocelectomy was carried out in 73 patients with clinical varicocele associated with premature ejaculation (group 1) and compared with 56 patients without operative intervention (group 2; control). The primary efficacy variable was the mean change in the Premature Ejaculation Diagnostic Tool. The changes in International Index of Erectile Function questionnaire, total serum testosterone and testicular size were also assessed. In group 1, the Premature Ejaculation Diagnostic Tool decreased significantly after varicocelectomy, from 15.56 to 11.37 (P < 0.001), indicating improvement of premature ejaculation. Thirty patients (41.1%) showed improvement of premature ejaculation compared to 5.3% in the control group (P < 0.001). In group I, but not in group II, testosterone levels and International Index of Erectile Function values increased significantly when compared with pre‐operative values (P < 0.001 and 0.040 respectively). Testicular size increased after varicocelectomy, but this increase was nonsignificant till the end of study (P = 0.054). We concluded that varicocelectomy is clearly related to improvement of premature ejaculation and testicular hormonal function in varicocele patients.     

Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomized,Double-Blind,Placebo-Controlled Phase 3 Trial in 22 Countries

Background

Dapoxetine is being developed for the on-demand treatment of premature ejaculation (PE). Previous clinical trials have demonstrated its safety and efficacy.

Objective

To evaluate the long-term efficacy and safety of dapoxetine in men with PE.

Design, setting, and participants

This randomized, double-blind, parallel-group, placebo-controlled, phase 3 trial, conducted in 22 countries, enrolled men (N = 1162) ≥18 yr of age who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE for ≥6 mo, with an intravaginal ejaculatory latency time (IELT) ≤2 min in ≥75% of intercourse episodes at baseline.

Intervention

Dapoxetine 30 mg or dapoxetine 60 mg or placebo on demand (1–3 h before intercourse) for 24 wk.

Measurements

Stopwatch-measured IELT, Premature Ejaculation Profile (PEP), Clinical Global Impression (CGI) of change, adverse events (AEs).

Results and limitations

The study was completed by 618 men. Mean average IELT increased from 0.9 min at baseline (all groups) to 1.9 min, 3.2 min, and 3.5 min with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively, at study end point; geometric mean IELT increased from 0.7 min at baseline to 1.1 min, 1.8 min, and 2.3 min, respectively, at study end point. All PEP measures and IELTs improved significantly with dapoxetine versus placebo at week 12 and week 24 (p < 0.001 for all). The most common AEs were nausea, dizziness, diarrhea, and headache. AEs led to discontinuation in 1.3%, 3.9%, and 8.2% of subjects with placebo and dapoxetine 30 mg and dapoxetine 60 mg, respectively. Limitations of this study included the exclusion of men who were not in long-term monogamous relationships.

Conclusions

Dapoxetine significantly improved all aspects of PE and was generally well tolerated in this broad population.