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Sexual Medicine Feb 2021Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but... (Review)
Review
INTRODUCTION
Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but its optimal dosage remains controversial.
AIM
In this systematic review and meta-analysis, we aimed to evaluate the efficacy, safety, and optimal dose of clomipramine for treating premature ejaculation among men.
METHODS
Eligible studies of PubMed, Embase, and Web of Science were identified from the date of inception to June 21, 2020. We conducted the study according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data of the study characteristics, intravaginal latency ejaculatory time (IELT), adverse events, success rate, and satisfaction rate of clomipramine vs placebo were extracted and analyzed. The risk ratio and mean difference were used for quantitatively analyzing binary outcomes and continuous outcomes. The standardized mean difference was applied to the outcome of satisfaction rate. The Mantel-Haenszel method was used for meta-analysis under random-effects model. To assess dose effect of clomipramine, a meta-regression analysis was performed.
MAIN OUTCOME MEASURES
The primary outcomes were the IELT and adverse events, and the secondary outcomes were the success rate and satisfaction rate of clomipramine treatment relative to the placebo.
RESULTS
A total 14 randomized controlled trials with 710 patients were included for quantitative analysis. Clomipramine significantly increased the IELT compared with the placebo (mean difference: 1.47, 95% CI: 0.73-2.21). However, clomipramine was associated with higher risks of overall adverse events and adverse events in the nervous and respiratory systems. Significant dosage effects on the IELT (estimate: 0.0637, 95% CI: 0.0074-0.12) and a slightly increasing slope on adverse events were revealed.
CONCLUSION
Clomipramine increased the IELT and yielded greater satisfaction than the placebo, and the higher dose results in a superior IELT without leading to higher risk of adverse events under a dosage of 50-mg clomipramine. Wu P-C, Hung C-S, Kang Y-N, et al. Tolerability and Optimal Therapeutic Dosage of Clomipramine for Premature Ejaculation: A Systematic Review and Meta-Analysis. Sex Med 2021;9:100283.
PubMed: 33291044
DOI: 10.1016/j.esxm.2020.10.011 -
Translational Andrology and Urology Aug 2016Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of... (Review)
Review
Large well-designed clinical efficacy and safety randomized clinical trials (RCTs) are required to achieve regulatory approval of new drug treatments. The objective of this article is to make recommendations for the criteria for defining and selecting the clinical trial study population, design and efficacy outcomes measures which comprise ideal premature ejaculation (PE) interventional trial methodology. Data on clinical trial design, epidemiology, definitions, dimensions and psychological impact of PE was reviewed, critiqued and incorporated into a series of recommendations for standardisation of PE clinical trial design, outcome measures and reporting using the principles of evidence based medicine. Data from PE interventional studies are only reliable, interpretable and capable of being generalised to patients with PE, when study populations are defined by the International Society for Sexual Medicine (ISSM) multivariate definition of PE. PE intervention trials should employ a double-blind RCT methodology and include placebo control, active standard drug control, and/or dose comparison trials. Ejaculatory latency time (ELT) and subject/partner outcome measures of control, personal/partner/relationship distress and other study-specific outcome measures should be used as outcome measures. There is currently no published literature which identifies a clinically significant threshold response to intervention. The ISSM definition of PE reflects the contemporary understanding of PE and represents the state-of-the-art multi-dimensional definition of PE and is recommended as the basis of diagnosis of PE for all PE clinical trials.
PubMed: 27652224
DOI: 10.21037/tau.2016.03.28 -
Translational Andrology and Urology Aug 2016Premature ejaculation (PE), delayed ejaculation (DE), anejaculation (AE) and retrograde ejaculation (RE) are four main ejaculatory disorders (EjDs) observed in clinical... (Review)
Review
Premature ejaculation (PE), delayed ejaculation (DE), anejaculation (AE) and retrograde ejaculation (RE) are four main ejaculatory disorders (EjDs) observed in clinical practice. Despite their high prevalence, EjDs remain underdiagnosed and undertreated. Primary care physicians should incorporate the discussion of sexual health topics into routine visits to facilitate EjD diagnosis and treatment. Because the causes of EjDs are multifactorial, the management of EjDs is etiology-specific and may require a holistic approach. Dapoxetine, a selective serotonin reuptake inhibitor, is the only drug approved for on-demand treatment of lifelong and acquired PE. In clinical practice, scheduled follow-up visits, risk factor treatment, appropriate dose escalation, adequate sexual attempts, patient education, and partner involvement are critical factors responsible for optimal overall management of PE and dapoxetine treatment outcomes.
PubMed: 27652225
DOI: 10.21037/tau.2016.05.07 -
Archivio Italiano Di Urologia,... Mar 2021The aim of the study is to extrapolate clinical features of Premature Ejaculation (PE) patients and female partners of men affected with PE, in order to get a profile... (Observational Study)
Observational Study
The aim of the study is to extrapolate clinical features of Premature Ejaculation (PE) patients and female partners of men affected with PE, in order to get a profile that can be of assistance for physicians within the dynamics of a couple, one of which is a PE patient. An observational, non-interventional, cross-sectional epidemiological study entitled IPER (Italian Premature Ejaculation Research) was conducted and included two different cohorts of subjects that were randomly sampled from a patient dataset of selected General Practitioners: 1. IPER-M sub-cohort (1.104 subjects) was made of male subjects in which they were then distinguished patients with or without PE based on the score of the PEDT questionnaire; IPER-F sub-cohort (1.109 subjects) was made of female subjects from an independent sample of women (therefore not the partners of the IPER-M males) in which they then distinguished those partners of a male subject with PE or not. In addition to an identical general questionnaire to explore demographic aspects and habits, each subcohort was then evaluated using validated questionnaires. No differences were noted between PE+/PE- patients in terms of alcohol consumption, smoking habits, physical activity nor stress condition in everyday life, employment, socio-economic class and marital status. While the prevalence of PE proportionally increased with age, excluding the 50-59 and 70-80 years decades, in the IPER-M group an overall statistically significant difference for the mean age between the PE+ and PE- groups (p = 0.002) was detected, but without reaching any difference amongst the different age classes in the IPER-F group. The PE+ patients reported a significantly lower frequency rate of sexual intercourse, worse QoL (p = 0.006 and p < 0.0001, respectively), and increased anxiety status (p < 0.0001 for both subgroups). This study shows that, rather than talking with a patient affected by PE it would be advisable to introduce the concept of couple counseling with the person patient and his partner, because it is only through classification of both partners as one couple and a full understanding of their mutual sexual experience that PE treatment can be optimized and its results measured accurately.
Topics: Adult; Cross-Sectional Studies; Female; Humans; Male; Middle Aged; Premature Ejaculation; Sexual Partners
PubMed: 33754608
DOI: 10.4081/aiua.2021.1.42 -
BMC Urology Jan 2019Paroxetine is one of the selective serotonin reuptake inhibitors (SSRIs) used in the treatment of premature ejaculation (PE). However, this use is not approved in many... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Paroxetine is one of the selective serotonin reuptake inhibitors (SSRIs) used in the treatment of premature ejaculation (PE). However, this use is not approved in many countries. The purpose of this systematic review and meta-analysis is to review the efficacy and safety of paroxetine for PE patients.
METHODS
We searched relevant randomized, controlled trials through May 2018, using PubMed, Embase and Cochrane Central Register. The main endpoint included intra-vaginal ejaculatory latency time (IELT) and side effects in the treatment of PE. Cochrane Collaboration's Revman software, version 5.3, was used for statistical analysis.
RESULTS
Out of 493 unique articles, a total of 19 randomized, controlled trials (RCTs) were reviewed. Quite a few RCTs were considered to have unclear risk of bias because of limited information. Pooled outcomes suggested that paroxetine was more effective than placebo, fluoxetine and escitalopram at increasing IELT (all p < 0.05). However, there existed a high level of heterogeneity in the paroxetine vs. fluoxetine groups and the paroxetine vs. placebo groups. Comparing paroxetine with tramadol, sertraline, phosphodiesterase 5 inhibitors (PDE5Is), local lidocaine gel, behaviour therapy or dapoxetine, we found that the increase in IELT was not statistically significant between groups. Paroxetine combined with tadalafil or behaviour therapy was more efficacious than paroxetine alone (all p < 0.05). Although the side effects in the combination group were more common than in the paroxetine alone group, the most common adverse events, such as nausea, muscle soreness, palpitation and flushing, were mild and tolerable. The main limitations of this systematic review and meta-analysis were the different definitions of PE and short follow-up times.
CONCLUSIONS
According to this systematic review and meta-analysis, paroxetine provided better efficacy than placebo, fluoxetine and escitalopram in the treatment of PE, with well-tolerated side effects. The combination group had better efficacy than the paroxetine alone group.
TRIAL REGISTRATION
This review was reported in agreement with the PRISMA statement and was registered on PROSPERO 2018CRD42018097014 .
Topics: Humans; Male; Paroxetine; Premature Ejaculation; Randomized Controlled Trials as Topic; Selective Serotonin Reuptake Inhibitors; Treatment Outcome
PubMed: 30606186
DOI: 10.1186/s12894-018-0431-7 -
F1000prime Reports 2014In spite of its high prevalence and long history, the ambiguity regarding the definition, epidemiology and management of premature ejaculation continues. Topical... (Review)
Review
In spite of its high prevalence and long history, the ambiguity regarding the definition, epidemiology and management of premature ejaculation continues. Topical anesthetic creams and daily or on-demand selective serotonin reuptake inhibitor (SSRI) treatment forms the basis of pharmacotherapy for premature ejaculation today, in spite of low adherence by patients. Psychotherapy may improve the outcomes when combined with these treatment modalities. Tramadol and phosphodiesterase type 5 inhibitors have a limited role in the management of premature ejaculation. Further research is required to develop better options for the treatment of this common sexual disorder.
PubMed: 25184045
DOI: 10.12703/P6-55 -
Translational Andrology and Urology Aug 2016The second Ad Hoc International Society for Sexual Medicine (ISSM) Committee for the Definition of Premature Ejaculation defined acquired premature ejaculation (PE) as a... (Review)
Review
The second Ad Hoc International Society for Sexual Medicine (ISSM) Committee for the Definition of Premature Ejaculation defined acquired premature ejaculation (PE) as a male sexual dysfunction characterized by a the development of a clinically significant and bothersome reduction in ejaculation latency time in men with previous normal ejaculatory experiences, often to about 3 minutes or less, the inability to delay ejaculation on all or nearly all vaginal penetrations, and the presence of negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. The literature contains a diverse range of biological and psychological etiological theories. Acquired PE is commonly due to sexual performance anxiety, psychological or relationship problems, erectile dysfunction (ED), and occasionally prostatitis and hyperthyroidism, consistent with the predominant organic etiology of acquired PE, men with this complaint are usually older, have a higher mean BMI and a greater incidence of comorbid disease including hypertension, sexual desire disorder, diabetes mellitus, chronic prostatitis, and ED compared to lifelong, variable and subjective PE.
PubMed: 27652216
DOI: 10.21037/tau.2016.07.06 -
Sexual Medicine Dec 2019The comorbidity between premature ejaculation (PE) and erectile dysfunction (ED) has not yet been clarified.
INTRODUCTION
The comorbidity between premature ejaculation (PE) and erectile dysfunction (ED) has not yet been clarified.
AIM
To assess the comorbidity between PE and ED.
METHODS
Male members of a shopping club in Taiwan aged 20-60 years with stable sexual relationships were invited to complete an online questionnaire.
MAIN OUTCOME MEASURES
Self-estimated intravaginal ejaculatory latency time (IELT), Premature Ejaculation Diagnostic Tool, Sexual Health Inventory for Men, Self-Esteem and Relationship, and Hospital Anxiety and Depression Scale results were used.
RESULTS
A total of 937 participants with a mean age of 41.1 ± 10.2 years were enrolled. The prevalence rates of ED (Sexual Health Inventory for Men ≤ 21), PE (Premature Ejaculation Diagnostic Tool ≥11), and IELT ≤1 minute were 24.7%, 6.3%, and 6.4%, respectively. Prevalence of acquired PE and IELT ≤1 minute increased marginally with age. Participants with ED had a greater prevalence of PE than those without ED (19.5% vs 2.0%, P < .001), and participants with PE had a greater prevalence of ED than those without PE (76.3% vs 19.4%, P < .001). Compared with participants without PE, participants with PE had greater adjusted odds of ED (odds ratio [OR] = 12.7, 95% CI = 6.7-24.2). Relative to participants without ED, participants with ED had increased adjusted odds of PE (OR = 7.2, 95% CI = 3.5-14.6 with mild ED and OR = 36.7, 95% CI = 16.2-83.0 with ED severity greater than a mild degree). Poor sexual relationships and self-esteem, depression, and anxiety were reported more frequently in those with PE or ED, especially in those with both problems compared with those without PE and ED.
CONCLUSIONS
This study confirmed a high prevalence of PE and ED coexistence, indicating a complicated relationship between the 2 conditions and the importance of screening for their co-occurrence in practice. Tsai W-K, Chiang P-K, Lu C-C, et al. The Comorbidity Between Premature Ejaculation and Erectile Dysfunction-A Cross-Sectional Internet Survey. Sex Med 2019;7:451-458.
PubMed: 31540883
DOI: 10.1016/j.esxm.2019.06.014 -
Asian Journal of Andrology Jul 2011Premature ejaculation (PE) is a common sexual disorder in men that is mediated by disturbances in the peripheral and central nervous systems. Although all pharmaceutical... (Review)
Review
Premature ejaculation (PE) is a common sexual disorder in men that is mediated by disturbances in the peripheral and central nervous systems. Although all pharmaceutical treatments for PE are currently used 'off-label', some novel oral agents and some newer methods of drug administration now provide important relief to PE patients. However, the aetiology of this condition has still not been unified, primarily because of the lack of a standard animal model for basic research and the absence of a widely accepted definition and assessment tool for evidence-based clinical studies in patients with PE. In this review, we focus on the current therapeutic strategies and future treatment perspectives for PE.
Topics: Adrenergic alpha-1 Receptor Antagonists; Animals; Antidepressive Agents; Drug Combinations; Ejaculation; Erectile Dysfunction; Humans; Lidocaine; Male; Models, Animal; Phosphodiesterase 5 Inhibitors; Prilocaine; Selective Serotonin Reuptake Inhibitors; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Tramadol
PubMed: 21532601
DOI: 10.1038/aja.2010.130 -
Fertility and Sterility Nov 2015Conventional theories and therapies for premature ejaculation (PE) are based on assumptions not always supported by evidence. This review of the current literature on... (Review)
Review
Conventional theories and therapies for premature ejaculation (PE) are based on assumptions not always supported by evidence. This review of the current literature on the physiology of the ejaculatory control, pathogenesis of PE, and available therapies shows that PE is still far from being fully understood. However, several interesting hypotheses have been formulated, and solid, evidence-based clinical data are currently available for dapoxetine, the unique, first-line, officially approved pharmacotherapy for PE. Further growth in the field of PE will occur only when we shift from opinion-based classifications, definitions, and hypotheses to robust, noncontroversial data grounded on evidence.
Topics: Animals; Benzylamines; Ejaculation; Hormones; Humans; Infertility, Male; Male; Marital Therapy; Naphthalenes; Penis; Premature Ejaculation; Recovery of Function; Risk Factors; Serotonin; Selective Serotonin Reuptake Inhibitors; Sexual Behavior; Synaptic Transmission; Treatment Outcome
PubMed: 26409323
DOI: 10.1016/j.fertnstert.2015.08.035