Evolving therapeutic strategies for premature ejaculation: The search for on-demand treatment �C topical versus systemic

Premature ejaculation (PE) is a common sexual dysfunction affecting 20% to 30% of men worldwide. Definitions of PE vary, but it is typically characterized by short intravaginal ejaculatory latency time (IELT) with concomitant sexual dissatisfaction and distress. PE may be lifelong or acquired, but its etiology remains unclear. Treatment of PE typically involves pharmacotherapy, particularly when lifelong. Although there are numerous reports on the off-label use of selective serotonin reuptake inhibitors (SSRIs) and other compounds, only 2 treatments have been evaluated in randomized controlled phase 3 clinical trials: PSD502 and dapoxetine (SSRI). Both significantly improved IELT and patient-reported outcome domains of ejaculatory control, sexual satisfaction, and distress as measured by the index of premature ejaculation (IPE), compared with placebo. They constitute the focus of this review. Evidence demonstrated that PSD502, dapoxetine and other SSRIs all significantly improve the symptoms of PE. Systemic use of SSRIs presents risks associated with the known pharmacology of this class. PSD502 allows for topical on-demand treatment applied applied immediately before intercourse, and is not associated with systemic adverse events.     

The link between penile hypersensitivity and premature ejaculation

Study Type – Aetiology (case control)
Level of Evidence 3b What’s known on the subject? and What does the study add? Very little is known about the aetiology of premature ejaculation. This analysis shows that many PE patients have a heightened penile sensitivity. This information could result in the design and development of new drugs.

OBJECTIVES

To investigate the correlation between penile hypersensitivity and premature ejaculation (PE), as defined by the criteria identified by the International Society of Sexual Medicine (ISSM). Penile hypersensitivity as a cause of PE is based on historical clinical neurophysiological data and clinical efficacy of the topical desensitizing agent PSD502 in the treatment of PE. PSD502 is a eutectic‐like mixture of two local anaesthetics, lidocaine and prilocaine, whose primary action is to reduce neuronal conduction in sensory afferents.

METHODS

Historical neurophysiological data was reviewed, together with data from the recent PSD502 clinical trials, including the first published double‐blind clinical trial data evaluating a topical desensitizing agent in a population of men with PE, as per the new ISSM definition. The clinical profile of PSD502, based on its local anaesthetic properties, is used as a surrogate index of the role of sensory afferents in the ejaculatory reflex.

RESULTS

The published data does not support unequivocally penile hypersensitivity as the cause of PE. Interpretation of the data is hampered by the variability of the populations described as having PE across studies. Data from the PSD502 clinical trials clearly shows that PSD502 increases ejaculatory latency, and improves control and sexual satisfaction when applied topically to men with PE 5 min before intercourse, enabling subjects to delay ejaculation up to six times longer than those who used a placebo.

CONCLUSION

The clinical profile of PSD502 lends credibility to the penile hypersensitivity hypothesis for PE. The predominant action of local anaesthetics is to reduce neuronal firing in sensory afferents; the clinical profile of PSD502, which shows improvement of ejaculatory function in the absence of a generalized reduction in penile sensitivity, can most readily be explained based on an underlying hypersensitivity in patients with PE.     

Perceived control over ejaculation is central to treatment benefit in men with premature ejaculation: results from phase III trials with dapoxetine

OBJECTIVES

To assess the utility of perceived control over ejaculation (‘control’) in the evaluation of treatment benefit in men with premature ejaculation (PE), and to compare effects associated with a two‐category or greater increase in this variable between men receiving dapoxetine and placebo.

PATIENTS AND METHODS

This subanalysis used combined data from all treatment groups in an integrated analysis of two identically designed, 12‐week, double‐blind, randomized, placebo‐controlled trials of dapoxetine. Men (2614) met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition, text revision) criteria for PE, had a stopwatch‐measured intravaginal ejaculatory latency time (IELT) of ≤2 min in ≥75% of events in a 2‐week baseline period, and self‐reported moderate or severe PE. Men received placebo or dapoxetine 30 or 60 mg, 1–3 h before intercourse. The stopwatch‐measured IELT was recorded for each episode; the patient‐reported global impression of change (PGI; 7‐point scale, ‘much worse’ to ‘much better’), control and satisfaction with sexual intercourse (5‐point scales, ‘very poor’ to ‘very good’) were assessed monthly. The utility of a two‐category or greater increase in control was evaluated by examining the relationship of this variable with IELT and satisfaction with sexual intercourse.

RESULTS

Of 2341 men with baseline and endpoint assessments, 96.8% reported ‘very poor’ or ‘poor’ control at baseline, and 748 (32%) reported a two‐category or greater increase in control after treatment. More than 95% of those men rated their PE as ‘slightly better’, ‘better’, or ‘much better’ on the PGI; 67.1% gave ratings of ‘better’ or ‘much better.’ They also had greater improvements in IELT than men with less than a two‐category increase in control, with a mean (sd ) change from baseline of 3.7 (4.3) vs 0.77 (1.8) min, respectively, and a greater percentage reported good or very good satisfaction with sexual intercourse than men with less than a two‐category increase in control (74% vs 19%, respectively). Nausea, headache and upper respiratory tract infection were the most common adverse events reported by men with a two‐category or greater increase in control (15.8%, 7.4% and 6.6%, respectively) and those without (8.5%, 5.5% and 6.5%, respectively). The proportions of men with a two‐category or greater increase in control with dapoxetine 30 and 60 mg were 36.3% and 44.5%, respectively (vs 15% with placebo).

CONCLUSIONS

A two‐category or greater increase in control (5‐point scale) is useful for assessing the treatment benefit in men with PE; it corresponds with improvements in the man’s perception of his condition, substantially greater prolongation of IELT, and higher levels of satisfaction with sexual intercourse.     

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.     

Analysis of association between the 5‐HTTLPR and STin2 polymorphisms in the serotonin‐transporter gene and clinical response to a selective serotonin reuptake inhibitor (sertraline) in patients with premature ejaculation

Study Type – Therapy (cohort)
Level of Evidence 2b

OBJECTIVE

To test the hypothesis that polymorphism within the gene‐linked polymorphic region (5‐HTTLPR) and second intron of SLC6A4 gene (STin2) is associated with selective serotonin‐reuptake inhibitors (SSRIs) response in subjects with premature ejaculation (PE).

PATIENTS AND METHODS

In all, 246 men with PE were recruited in this study. They were asked to take sertraline 50 mg daily for 2 weeks, and thereafter 100 mg daily, for a 12‐week treatment period. Pretreatment evaluation included history and physical examination, intravaginal ejaculatory latency time (IELT), and International Index of Erectile Function (IIEF). The efficacy of treatment was assessed using responses to IIEF, and geometric mean IELT evaluation. 5‐HTTLPR was genotyped using polymerase chain reaction techniques. A repeated‐measures analysis of variance of geometric mean IELT was done to test a genotype effect on treatment outcome with SSRI (sertraline).

RESULTS

Of 227 participants who completed the study, 175 (77.1%) responded to sertraline (IELT >1 min). Overall the patients had a 3.7‐fold (95% confidence interval, CI, 1.72–5.46) increase of the geometric mean IELT (P = 0.001). The results showed that responses were significantly better for the L_A/L_A genotype of the 5‐HTTLPR polymorphism than for S‐allele carriers (P = 0.001). The STin2 12/12 genotype was found more often in those responding to sertraline than in those not responding (P = 0.001). The probability of patients responding sufficiently to sertraline with an L_A/L_A genotype was highest (odds ratio 4.66, 95% CI, 2.48–6.14).

CONCLUSIONS

These findings indicate that the genotype of 5‐HTT contributes in unique ways to the variation in the outcome of PE treatment with SSRIs.     

Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation

OBJECTIVE: To evaluate, in a phase II study, the efficacy and safety of a topical eutectic mixture for premature ejaculation (TEMPE), a metered-dose aerosol spray containing a eutectic mixture of lidocaine and prilocaine, as a treatment for PE. PATIENTS AND METHODS: Men with PE (Diagnostic and Statistical Manual-IV definition) aged 18-75 years were randomized into a double-blind, placebo-controlled study in the UK and the Netherlands. Efficacy variables included the mean change in intravaginal ejaculatory latency time (IELT) from baseline and the proportion of patients who achieved an IELT of > or = 4, > or = 3 or > or = 2 min on two occasions, and the effect of TEMPE on the index of ejaculatory control (IEC) and sexual quality-of-life (SQoL) scores of patients and their partners. Safety and adverse event data were also collected. Fifty-four patients were randomized and received study treatment. RESULTS: The observed mean change in IELT from baseline to the end of the treatment period was 3.8 min in the TEMPE group and 0.7 min in the placebo group, and when adjusted for baseline and centre was 2.4 times higher in the TEMPE than the placebo group (P < 0.01). The efficacy of TEMPE in increasing IELT was further supported by positive trends in the other efficacy endpoints. The proportion of men who had an IELT time > or = 2, > or = 3 or > or = 4 min on two occasions after treatment was 11/20 (55%), 8/20 (40%) and 5/25 (20%) in the TEMPE group, and 8/23 (35%), 3/23 (13%) and 3/23 (13%) in the placebo group, respectively, although these differences were not statistically significant. Improvements in IEC and SQoL (male and female) scores also showed trends towards greater efficacy for TEMPE than placebo. In all, 35 of 42 (83%) patients considered the spray easy to use. Mild to moderate local numbness occurred in three (12%) of the TEMPE-treated patients but did not lead to discontinuation. CONCLUSION: Topical treatment with TEMPE produced a statistically and clinically significant increase in IELT compared with placebo, and resulted in positive trends in ejaculatory control and SQoL. TEMPE was considered easy to use and was well tolerated. The data support the conduct of further large-scale studies to establish the utility of TEMPE as a first-line treatment for PE.     

Impact of physical activity on patient self‐reported outcomes of lifelong premature ejaculation patients: Results of a prospective,randomised, sham‐controlled trial

Previous studies have investigated whether physical activity increases serotonin hormone levels. Serotonin receptor dysfunction is one of the frequently accused factors of premature ejaculation (PE). Nevertheless, no studies up to date have demonstrated that the association between physical activity and premature ejaculation. We aimed to investigate the relationship between physical activity and PE and determine whether moderate physical activity might delay ejaculation time or be an alternative treatment for PE. A total of 105 patients diagnosed with PE were enrolled in this study. Of the patients, 35 were treated with dapoxetine, (30 mg) on demand (Group 1), 35 performed moderate physical activities (Group 2), and 35 performed minimal physical activity (Group 3‐sham). Demographic characteristics, metabolic equivalents (MET), premature ejaculation diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT) were recorded. There were no significant differences among three groups in terms of age, BMI, MET, PEDT or IELT before treatment. At the end of the study, there was significant decrease in PEDT scores, and increase in IELT in groups 1 and 2 as compared to Group 3. In conclusion, a moderate physical activity longer than 30 min at least 5 times a week leads to ejaculation delay, and appears as an alternative to dapoxetine on demand for the treatment of PE.     

Combination therapy with selective serotonin reuptake inhibitors and phosphodiesterase‐5 inhibitors in the treatment of premature ejaculation

We aimed to evaluate the effectiveness of paroxetine and tadalafil combination in the treatment of premature ejaculation (PE). A total of 150 primary (lifelong)PE patients were randomly distributed into three groups of 50 patients each. Group 1 received 20 mg paroxetine every day for 1 month, Group 2 received 20 mg tadalafil on demand 2 h before intercourse, and Group 3 received paroxetine and tadalafil on demand 2 h before intercourse. Intravaginal ejaculatory latency times (IELT) scores were evaluated at baseline, at the end of the first month of therapy and 1 month after discontinuation of the treatment, while International Index of Erectile Function (IIEF) questionnaire scores were evaluated both prior to and after the treatment. At the end of the first month of therapy, IELT scores were compared with the basal values and statistically significant changes were detected (60.6 ± 30.2–117.3 ± 67.3, 68.5 ± 21.4–110.2 ± 37.3, 71.56 ± 40.23–175.2 ± 60.2)(P < 0.01). IELT scores after discontinuation of treatment were found to be close to the baseline IELT scores (P > 0.05). IIEF scores were evaluated both prior to and after the treatment, and no statistically significant difference was detected (P > 0.05). It is concluded that utilisation of selective serotonin reuptake inhibitors (SSRI) and phosphodiesterase‐5 inhibitors (PDE5i) combination before intercourse seems to provide significantly longer ejaculatory latency times as compared with SSRI alone for a long time in patients with PE.     

On‐demand d‐modafinil may be an effective treatment option for lifelong premature ejaculation: a case report

Premature ejaculation (PE) is considered to be the most common form of male sexual dysfunction. Given that acute oral administration of d‐isomer of modafinil (d‐modafinil) can extend the latency to ejaculation in rats without suppressing sexual behaviour, the effects of on‐demand d‐modafinil treatment were examined on a 30‐year‐old male patient with lifelong PE. The patient was instructed to take d‐modafinil 100 mg 3 h prior to the sexual relation for four times and was invited for a control visit. The patient was re‐evaluated 2 weeks later. He reported that his IELT increased to 15 min. He reported heartburn and insomnia when he used d‐modafinil for the first time; however, these symptoms were transient and did not recur after the initial dose. Overall, he reported considerable improvement and noted that he feels much better with the treatment. Based on this limited data, on‐demand d‐modafinil seems to be an effective treatment for men with lifelong PE. The side effects were transient and mild in the reported case. Further randomised clinical trials are necessary to elucidate the therapeutic concept of this drug in patients with lifelong PE.     

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.     

Identifying constructs and criteria for the diagnosis of premature ejaculation: implication for making errors of classification

OBJECTIVES

To review the many definitions of premature ejaculation (PE), determine the essential elements that best define PE, and examine and discuss the consequences of errors of inclusion and exclusion in the diagnosis of PE.

METHODS

We reviewed recent evidenced‐based studies that delineate the variables that best define PE, and the relationships between these factors. We then assessed the consequences of errors of measurement, inclusion and exclusion for setting the thresholds for the three variables.

RESULTS

PE can best be defined by a multidimensional set of criteria composed of three essential elements: (i) intravaginal ejaculatory latency time (IELT); (ii) a lack of perceived self‐efficacy or control about the timing of ejaculation; and (iii) distress and interpersonal difficulty related to the ejaculatory dysfunction. After delineating the variables, thresholds for each variable need to be determined. Carefully constructed thresholds attempt to minimize errors of inclusion and exclusion. However, even the best criteria cannot eliminate all error. The two types of errors in classification are, to some extent, inversely related: the more restrictive the criteria, the more likely that there will be errors of exclusion, whereas the more lenient the criteria the more likely there will be errors of inclusion.

CONCLUSION

Research and treatment protocols might use different threshold values for classification, as their goals might be different. For a PE research protocol, we suggest erring on the side of a more narrow definition as it would: (i) provide a more conservative, and we think, realistic prevalence of the disorder; (ii) help to establish PE as a bona fide sexual dysfunction rather than a ‘life‐style’ issue for men seeking to enhance their sexual life; (iii) ensure greater confidence in the efficacy of existing and new treatment approaches; and (iv) strengthen the likelihood of acceptance by the regulatory authorities. Conversely, standard treatment protocols for PE might use more lenient criteria if the treatment has minimal adverse events and the degree of distress of the sufferer is high.     

Does lidocaine ointment addition increase fluoxetine efficacy in the same group of patients with premature ejaculation?

PURPOSE: To evaluate the efficacy of fluoxetine alone and fluoxetine+lidocaine ointment in the same patient group with premature ejaculation (PE). MATERIAL AND METHODS: 78 patients with PE were given 20 mg fluoxetine by an 'as-needed treatment' 4 h before planned sexual activity for a period of 3 months. They were then told to add local lidocaine ointment to fluoxetine 30 min before sexual activity for an additional 3 months for most of their sexual attempts. They were asked to note their PE grades and intravaginal ejaculatory latency time (IELT) scores by stopwatch technique before and after each treatment modality; the results were compared statistically afterwards. RESULTS: Of 46 patients who completed the study, the mean pretreatment, fluoxetine alone and fluoxetine+lidocaine ointment treatment PE grades and IELT scores were found to be 6.52+/-1.42 and 2.58+/-0.49, 3.21+/-1.86 and 1.28+/-0.71, 2.17+/-1.56 and 1.04+/-0.72, respectively, showing a decrease in PE grades and IELT scores in combined therapy. On an individual patient basis, the total significant and moderate improvement rate of combined therapy was found to be 86.9%. Failure was observed in 6 (13.1%) patients. CONCLUSION: The effective treatment with fluoxetine+lidocaine ointment offers the advantage of an 'as-needed treatment' in PE with minimal side effects and can be used as one of the first-line alternatives in the treatment of PE.     

The Impact of Premature Ejaculation on Partners and Relationships

ObjectivesPremature ejaculation (PE) is a common condition in adult males that remains underdiagnosed and undertreated, partially because the sensitive nature of the topic discourages open discussions between affected males, their partners, and physicians. In addition to reduced sexual satisfaction, PE can have emotional consequences such as distress and dissatisfaction with the overall relationship, not only for the males but also their partners, the perspectives of whom have not been widely studied.MethodsAn online survey of female partners of men with PE was conducted to determine how the condition affects women and their relationships.ResultsThe results revealed that the relatively short intravaginal ejaculatory latency time (IELT) associated with PE causes emotional distress for the female partners (N = 115). The majority of female partners wanted to experience a prolonged IELT and considered that this would enhance both their sexual and overall relationship with their partner.ConclusionsIncreased awareness of the nature of the emotional and relationship ramifications of PE on men and their sexual partners should enhance the development of treatment options beyond pharmacotherapy alone.     

A Novel Treatment of Premature Ejaculation

The investigation of the etiology and treatment of premature ejaculation (PE), a common and significant problem for men and their partners, has been limited by the lack of defined outcomes and differences in clinical trial designs. Currently, no medication has been approved for the treatment for PE worldwide. Recognition of serotonin as a key mediator in ejaculatory signaling has raised interest in the utility of pharmacologic intervention for treating PE. Selective serotonin reuptake inhibitors (SSRIs) have been used off-label for PE, with varied results. However, treatment with currently available SSRIs typically requires chronic dosing that increases drug accumulation and the attendant risk of adverse events. Dapoxetine is an SSRI with a short half-life (1.2 h), developed specifically for the treatment of men with PE. This agent has a unique pharmacokinetic profile characterized by rapid absorption and elimination. Dapoxetine is metabolized by multiple pathways, and no clinically relevant drug–drug interactions have been identified. Furthermore, dapoxetine pharmacokinetics do not appear to be affected by food, age, alcohol, or phosphodiesterase type 5 (PDE5) inhibitors to a relevant degree. In two placebo-controlled phase 3 trials involving >2600 men with PE, dapoxetine 60 mg given as needed over 12 wk significantly prolonged the stopwatch-assessed intravaginal ejaculatory latency time (IELT) from 0.91 min at baseline to 3.32 min (p < 0.0001), increased control over ejaculation, and increased sexual satisfaction for men and their partners compared with placebo (both p < 0.0001). These results suggest that dapoxetine may meet the medical need for on-demand therapy for PE.     

A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine for treatment of lifelong premature ejaculation

Premature ejaculation (PE) is the most common male sexual disorder. We compared pelvic floor muscle rehabilitation to on-demand treatment with the selective serotonin reuptake inhibitor dapoxetine in 40 men with lifelong PE (baseline intra-vaginal ejaculatory latency time (IELT) ≤1 min). Subjects were randomized into the following two treatment groups: (1) PFM rehabilitation or (2) 30 or 60 mg of on-demand dapoxetine. Total treatment time for both groups was 12 weeks, at the end of which, IELT mean values were calculated to compare the effectiveness of the two different therapeutic approaches. At the end of treatment, 11 of the 19 patients (57%) treated with rehabilitation were able to control the ejaculation reflex, with a mean IELT of 126.6 sec (range: 123.6-152.4 sec). In the dapoxetine group, after 12 weeks of therapy, 5 of 8 (62.5%) patients in the 30 mg subgroup and five of seven (72%) in the 60 mg subgroup had an IELT >180 sec (mean: 178.2 and 202.8 sec, respectively). The results obtained in the group treated with pelvic floor rehabilitation are promising, and this treatment represents an important cost reduction if compared to dapoxetine on-demand treatment. The present study confirms the data that are previously available in the literature on the efficacy and safety of the new inhibitor of serotonin reuptake, dapoxetine, as well as proposes and evaluates a new type of physical treatment that may be a viable therapeutic option for treatment of PE.     

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.

     

口服帕罗西汀治疗早泄的随机对照研究

目的:验证帕罗西汀对早泄的治疗效果。方法:将符合纳入标准的80例早泄患者随机分为试验组和对照组,每组40例。所有患者进入为期4周的基线水平观察期,记录治疗前的阴道内射精潜伏时间(IELT)和性交满意度分值。试验组每天口服帕罗西汀20 mg,对照组口服安慰剂。治疗30 d后记录每个患者治疗后的IELT值和性交满意度分值。结果:试验组治疗后平均IELT与治疗前比较明显延长(5.75±1.24 min vs 0.89±0.21min,P<0.01),性交满意度与治疗前比较明显提高(6.4±1.2分vs 2.7±0.9分,P<0.01)。对照组治疗后平均IELT和性交满意度与治疗前比较均无显著性差异(1.06±0.28 min vs 0.97±0.18 min,3.6±1.3分vs 3.1±1.1分,P>0.05)。结论:早泄患者每天口服帕罗西汀20 mg,30 d后IELT和性交满意度均有明显改善。     

帕罗西汀与达帕西汀的对比，治疗早泄的新的选择性5-羟色胺再摄取抑制剂

达帕西汀氢氯化物是一种选择性5-羟色胺再摄取抑制剂,也是第一种被批准可以按需服用治疗早泄的药物。本文目的为研究按需服用达帕西汀（30mg和H60mg）和每日服用帕罗西汀（20mg）对早泄的疗效。研究募集了150名患者进行了长达1个月的研究。患者被分成3组,每组50人。第一组按需服用达帕西汀30mg。第二组按需服用达帕西汀60mg。第三组每日服用帕罗西汀20mg。治疗结束后,我们的结果检测值相对于基准阴道内射精潜伏期（IELT）延长了。与基准IELT相比,帕罗西汀组、30mg达帕西汀组和60mg达帕西汀组的治疗后IELT分别延长了117％（P〈0．01）,117％（P〈0．01）和170％（P〈0．01）。30mg达帕西汀组和帕罗西汀组的IELT增幅相同（P〉0．05）,而60mg达帕西汀组的IELT增幅明显高于30mg达帕西汀组（P〈0．05和帕罗西汀组P〈0．01）。性交前1～3小时服用达帕西汀60mg是针对早泄的非常有效的治疗方法。然而,与当前普遍使用的帕罗西汀相比,达帕西汀30mg疗效并不显著。     

Topical anaesthetic use for treating premature ejaculation: a double-blind, randomized, placebo-controlled study

OBJECTIVE: To assess the use of a topical anaesthetic mixture to improve premature ejaculation (PE), for which penile hypersensitivity might be a cause. PATIENTS AND METHODS: The study included 42 men divided in two groups; group A used a lidocaine-prilocaine solution and group B used an inert cream. The tubes of cream were distributed randomly and participants asked to note any unpleasant symptoms, difficulties and the results of each attempt at intercourse, assessed by the intravaginal ejaculatory latency time (IELT). RESULTS: There was a significant increase in the mean (sd) IELT, from 1.49 (0.9) to 8.45 (0.9) min (P < 0.001) in group A but not in group B, at 1.67 (0.7) to 1.95 (0.12) min (P > 0.05). CONCLUSION: We suggest that anaesthetic cream might be effective for treating PE.     

Der vorzeitige Samenerguss (Ejaculatio praecox)

With prevalence rates of 20%–25% premature ejaculation (PE) represents the most frequent sexual dysfunction in men. Whereas genetically determined changes in the serotonin receptor-/transporter mechanism seem to be responsible for lifelong PE, acquired PE is often associated with other conditioning diseases such as erectile dysfunction, prostatitis or thyroid dysfunctions. Typical features of PE are a short intravaginal ejaculatory latency time (IELT) <1–2 min, lack of control over ejaculation, personal distress and partner problems. Treatment of PE subdivides into sexual therapy as well as drug therapy. Among the medications considered for PE, oral therapy with selective serotonin re-uptake inhibitors (SSRI), Dapoxetine (the first officially approved medication for PE) and topical therapy with lidocaine/prilocaine-containing medications are given priority.