Effects of vardenafil administration on intravaginal ejaculatory latency time in men with lifelong premature ejaculation

Aversa, Antônio; Pili, M; Francomano, Davide; Bruzziches, Roberto; Spera, Enrico; Pera, Giuseppe; Spera, Giovanni

doi:10.1038/ijir.2009.21

Cited by 87 publications

(92 citation statements)

References 31 publications

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“…The evidence for PDE5 inhibitors was reported in 12 RCTs, 39 138 and tadalafil 141 both significantly increased IELT compared with placebo, (MD 3.80 minutes, 95% CI 3.30 to 4.30 minutes; and 2.59 minutes, 95% CI 1.28 to 3.90 minutes; p < 0.00001 and p = 0.0001, respectively). There was no significant difference in IELT between sildenafil and placebo in one RCT.…”

Section: Phosphodiesterase-5 Inhibitorsmentioning

confidence: 97%

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Interventions to treat premature ejaculation: a systematic review short report

Cooper

James

Kaltenthaler

et al. 2015

Health Technology Assessment

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BackgroundPremature ejaculation (PE) is commonly defined as ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the person wishes it. PE can be either lifelong and present since first sexual experiences (primary), or acquired (secondary), beginning later (Godpodinoff ML. Premature ejaculation: clinical subgroups and etiology.J Sex Marital Ther1989;15:130–4). Treatments include behavioural and pharmacological interventions.ObjectiveTo systematically review evidence for clinical effectiveness of behavioural, topical and systemic treatments for PE.Data sourcesThe following databases were searched from inception to 6 August 2013 for published and unpublished research evidence: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects and theHealth Technology Assessmentdatabase; ISI Web of Science, including Science Citation Index, and the Conference Proceedings Citation Index-Science. The US Food and Drug Administration website and the European Medicines Agency (EMA) website were also searched.MethodsRandomised controlled trials (RCTs) in adult men with PE were eligible (or non-RCTs in the absence of RCTs). RCT data were extrapolated from review articles when available. The primary outcome was intravaginal ejaculatory latency time (IELT). Data were meta-analysed when possible. Other outcomes included sexual satisfaction, control over ejaculation, relationship satisfaction, self-esteem, quality of life, treatment acceptability and adverse events (AEs).ResultsA total of 103 studies (102 RCTs, 65 from reviews) were included. RCTs were available for all interventions except yoga. The following interventions demonstrated significant improvements (p < 0.05) in arithmetic mean difference in IELT compared with placebo:topical anaesthetics– eutectic mixture of local anaesthetics (EMLA®, AstraZeneca), topical eutectic mixture for PE (Plethora Solutions Ltd) spray;selective serotonin reuptake inhibitors(SSRIs) – citalopram (Cipramil®, Lundbeck), escitalopram (Cipralex®, Lundbeck), fluoxetine, paroxetine, sertraline, dapoxetine (Priligy®, Menarini), 30 mg or 60 mg;serotonin–noradrenaline reuptake inhibitors– duloxetine (Cymbalta®, Eli Lilly & Co Ltd);tricyclic antidepressants– inhaled clomipramine 4 mg;phosphodiesterase-5(PDE5)inhibitors– vardenafil (Levitra®, Bayer), tadalafil (Cialis®, Eli Lilly & Co Ltd);opioid analgesics– tramadol (Zydol SR®, Grünenthal). Improvements in sexual satisfaction and other outcomes compared with placebo were evident for SSRIs, PDE5 inhibitors and tramadol. Outcomes for interventions not compared with placebo were as follows:behavioural therapies– improvements over wait list control in IELT and other outcomes, behavioural therapy plus pharmacotherapy better than either therapy alone;alpha blockers– terazosin (Hytrin®, AMCO) not significantly different to antidepressants in ejaculation control;acupuncture– improvements over sham acupuncture in IELT, conflicting results for comparisons with SSRIs;Chinese medicine– improvements over treatment as usual;delay device– improvements in IELT when added to stop–start technique;yoga– improved IELT over baseline, fluoxetine better than yoga. Treatment-related AEs were evident with most pharmacological interventions.LimitationsAlthough data extraction from reviews was optimised when more than one review reported data for the same RCT, the reliability of the data extraction within these reviews cannot be guaranteed by this assessment report.ConclusionsSeveral interventions significantly improved IELT. Many interventions also improved sexual satisfaction and other outcomes. However, assessment of longer-term safety and effectiveness is required to evaluate whether or not initial treatment effects are maintained long term, whether or not dose escalation is required, how soon treatment effects end following treatment cessation and whether or not treatments can be stopped and resumed at a later time. In addition, assessment of the AEs associated with long-term treatment and whether or not different doses have differing AE profiles is required.Study registrationThis study is registered as PROSPERO CRD42013005289.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Phosphodiesterase-5 Inhibitorsmentioning

confidence: 97%

“…One RCT assessed tadalafil 20mg one to 36 hours preintercourse 141 and two RCTs assessed vardenafil. 138,140 The vardenafil doses for these RCTs were not available from any reviews.…”

Section: 120mentioning

confidence: 99%

Interventions to treat premature ejaculation: a systematic review short report

Cooper

James

Kaltenthaler

et al. 2015

Health Technology Assessment

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“…The second study compares vardenafil with placebo. 39 In this study, patients who took vardenafil (vs placebo) reported significantly increased ejaculatory control, improved overall sexual satisfaction and distress scores, respectively. Interestingly, multiple regression analysis for IELT by the number of attempts at sexual intercourse showed significant differences between the slopes of lines for placebo and vardenafil.…”

Section: Pde5-i In Pementioning

confidence: 97%

Is there a role for phosphodiesterase type-5 inhibitors in the treatment of premature ejaculation?

et al. 2011

Self Cite

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Premature ejaculation (PE) is considered to be the most common male sexual dysfunction. The realization that PE may co-exist with ED prompted the use of PDE5-i's alone or in combination with selective serotonin reuptake inhibitors (SSRIs) for treating ejaculatory disorders. Until recently, there was little evidence that PDE5-i's alone may have a role in the treatment of PE in the absence of ED, and current available treatments include only on-demand dapoxetine. However, available data indicate that there is clinical, anatomical, physiological, pharmacological and genetic evidence to explain the efficacy of PDE5-i's. Nine manuscripts that examined the efficacy of PDE5-i's in the treatment of PE, alone or in combination with SSRIs, were retrieved. All studies reported some significant changes in the intravaginal ejaculatory latency time and sexual satisfaction scores, although not all were clinically meaningful. Well-designed multicenter studies are urgently required to further elucidate the efficacy and safety, as well as the mechanisms of action of PDE5-i's in the treatment of PE. The aim of this review is to discuss basic rationale and to show clinical evidence sustaining the possibility to use off-label PDE5-i's to treat PE.

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“…56 Two studies of vardenafil for PE showed that it increases IELT and reduces the post-ejaculation refractory period in men with lifelong PE. 58,59 A double-blind, prospective, crossover study compared the effectiveness of sildenafil with the squeeze technique and on-demand use of two different SSRIs (paroxetine and sertraline) and clomipramine in patients with primary PE. Sildenafil demonstrated a 15-fold increase in IELT compared with two-to fourfold increases for the other groups.…”

Section: Pde-5ismentioning

confidence: 99%

Current therapeutic strategies for premature ejaculation and future perspectives

Xin¹,

Zhu²,

Yuan³

et al. 2011

Asian J Androl

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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. Ejaculation is a tightly coordinated activity with different ejaculatory organs and a spinal reflex initiated by genital and/or brain stimulation through the peripheral sensory receptors and regions, afferent pathways, the central nervous system ejaculatory centre of the brain (namely, sensory and motor areas located in the para-ventricular nucleus of the hypothalamus and the medial preoptic area). The spinal ejaculatory centre, located at the T 12 -L 1-2 spinal cord level (paragigantocellular), and its efferent pathway modulate the function of the ejaculatory organs. Ejaculation is also mediated by a complex interaction of central serotonergic and dopaminergic neurons with the secondary involvement of cholinergic, adrenergic, oxytocinergic and GABAergic neurons.Ejaculation consists of two main phases, the emission phase and the expulsion phase. The emissions include seminal fluid and secretions of the prostate and bulbourethral glands. In this phase, the contraction of accessory ejaculatory organs induces the accumulation of semen in the posterior urethra. Expansion of the posterior urethra creates a feeling of emission and sensory information that is transmitted to the spine via dorsal nerve sensory pathway and along the spinal cord up to the brain ejaculatory centre during the sexual arousal phase. The expulsion phase consists of the highly regular rhythmic contraction of striated muscles and the relaxation of smooth muscles in the ejaculatory ducts. The ejaculated semen can be divided into a number of components by serial biochemical analysis. 1 These include secretions from the seminal vesicles, prostate and bulbourethral (Cowper's) glands and spermatozoa.

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Effects of vardenafil administration on intravaginal ejaculatory latency time in men with lifelong premature ejaculation

Cited by 87 publications

References 31 publications

Interventions to treat premature ejaculation: a systematic review short report

Interventions to treat premature ejaculation: a systematic review short report

Is there a role for phosphodiesterase type-5 inhibitors in the treatment of premature ejaculation?

Current therapeutic strategies for premature ejaculation and future perspectives

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