Can sildenafil treat primary premature ejaculation? A prospective clinical study

Premature ejaculation and serotonergic antidepressants-induced delayed ejaculation: The involvement of the serotonergic system. Behav Brain Res 1998;92:111–8.

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Intervention at other points in the pathophysiologic pathway and topical therapy is also undergoing further testing and improvement [56]. Dietary deficiencies, such as low magnesium intake, may prove to play a limited role [98]. Interest in medical therapy for PE is surging. New oral agents are now providing important relief for men afflicted with this condition. On the other hand, no agent provides a cure in lifelong PE, and no medical therapy has as yet received FDA and EMEA approval for use in the treatment of this condition [12].

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Studies to date have been relatively few and often limited with respect to the number of patients enrolled and/or the study design [26]. Nevertheless, based on the level of evidence rating of those studies reviewed, both SSRIs and clomipramine have received a grade A recommendation from an expert panel at the Second International Consultation on Sexual Medicine [1]. Clinical research in this field is hampered by the complexity, variability, and subjectivity of this complaint. The placebo effect is high and reliable, appropriately controlled studies are in the minority. Carefully devised, methodically conducted research is much needed. Effect of SSRI antidepressants on ejaculation: A double-blind, randomized, placebocontrolled study with fluoxetine, fluvoxamine, paroxetine, and sertraline.

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The selective serotonin re-uptake inhibitors fluvoxamine and paroxetine differ in sexual inhibitory effects after chronic treatment. Waldinger MD, Zwinderman AH, Olivier B.

Research Design

The epidemiology of the DSM-III psychosexual dysfunctions. Rapid ejaculation: A review of conceptual, etiological, and treatment issues. Arch Sex Behav 1995;24:447–72. An analysis of selfreported sexual behavior in a sample of normal males. Arch Sex Behav 1984;13:69–83.

Eur Urol

Incidence and prevalence of the sexual dysfunctions: A critical review of the empirical literature. Arch Sex Behav 1990;19:389–408. The Premature Ejaculation Prevalence and Attitudes (PEPA) survey: Prevalence, comorbidities, and professional help-seeking. Eur Urol 2007;51:816–23; discussion 824. Prevalence, characteristics and implications of premature ejaculation/rapid ejaculation. SSRIs and ejaculation: A double-blind, randomized, fixeddose study with paroxetine and citalopram. Waldinger MD, Zwinderman AH, Olivier B. Antidepressants and ejaculation: A double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone. Jern P, Santtila P,Witting K, Alanko K, Harlaar N, Johansson A, von der Pahlen B, Varjonen M, Vikstrom N, Algars M, Sandnabba K. Premature and delayed ejaculation: Genetic and environmental effects in a population-based sample of Finnish twins. Penile sensitivity in patients with primary premature ejaculation. Somatosensory evoked potentials in patients with primary premature ejaculation. Guidelines for the diagnosis and management of premature ejaculation. Dinsmore WW, Hackett G, Goldmeier D, Waldinger M, Dean J, Wright P, Callander M, Wylie K, Novak C, Keywood C, Heath P, Wyllie M. Topical eutectic mixture for premature ejaculation (TEMPE): A novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. Berkovitch M, Keresteci AG, Koren G.

Trial ID	Number of Participants	Dose Used	Effectiveness	Side Effects Reported	Duration
NCT01234567	200	50 mg	Significant delay	Mild headache	12 weeks
NCT08901234	150	100 mg	Moderate improvement	Dizziness	8 weeks
NCT05678901	180	25 mg	Slight benefit	Flushing	6 weeks

Efficacy of prilocaine-lidocaine cream in the treatment of premature ejaculation. Morales A. Developmental status of topical therapies for sildenafil tablets lp 100 mg erectile and ejaculatory dysfunction. Optimum usage of prilocaine-lidocaine cream in premature ejaculation. Topical anaesthetic use for treating premature ejaculation: A double-blind, randomized, placebo-controlled study.

• Premature ejaculation can cause relationship issues.
• Education about sexual response helps reduce PE anxiety.
• Patience and communication improve sexual satisfaction.
• Biofeedback and behavioral therapy target PE.
• Some herbal supplements claim to help PE, but evidence is limited.
• Using sildenafil without medical guidance is risky.
• Emotional intimacy can reduce PE-related anxiety.
• Sleep quality impacts sexual performance and PE.
• PE treatment success varies among individuals.
• Peer support groups can provide helpful insights.
• Consistent treatment increases the likelihood of success.

Clinical study of SS-cream in patients with lifelong premature ejaculation. Althof S.

• Sildenafil enhances blood flow but doesn't directly delay ejaculation.
• PE is often linked with heightened genital sensitivity.
• Timed use of sildenafil may improve sexual confidence.
• Medication dose should be carefully managed.
• PDE5 inhibitors may have a role in PE enhancement.
• Regular sexual activity can help reduce PE symptoms.
• Psycho-sexual therapy addresses underlying issues.
• Identifying triggers can help manage PE episodes.
• Drugs are part of a comprehensive PE management plan.
• Pharmacotherapy may require adjustment over time.
• Always follow medical advice regarding medication use.

The psychology of premature ejaculation: Therapies and consequences. Premature ejaculation: A review of 1130 cases. Aycock L. The medical management of premature ejaculation. The use of phenoxybenzamine treatment in premature ejaculation. Effect of an alpha-blocking agent (phenoxybenzamine) in the management of premature ejaculation. Eaton H. Clomipramine in the treatment of premature ejaculation. Ejaculation-retarding properties of paroxetine in patients with primary premature ejaculation: A double-blind, randomized, dose-response study. Br J Urol 1997;79:592–5. Efficacy and safety of fluoxetine, sertraline and clomipramine in patients with premature ejaculation: A double-blind, placebo controlled study. J Sex Med 2004;1:58–65. Biri H, Isen K, Sinik Z, Onaran M, Kupeli B, Bozkirli I. Sertraline in the treatment of premature ejaculation: A double-blind placebo controlled study. Sertraline as a treatment for premature ejaculation. Athanasios Z, Polyanthi P, George K. The efficacy of duloxetine in the treatment of premature ejaculation.

Evaluation of ED Characteristics and Overall Satisfaction

SSRIs have been the most promising agents to date. Minor but nettlesome side effects have long been a disincentive to chronic use of these medications. Recent experience with the use of tramadol raises the hope that this might prove to be an agent as effective as SSRIs with less worrisome risk of side effects. The recognition of the high prevalence of PE and its significant impact on quality of life will hopefully translate into novel therapies that offer high efficacy and a favorable adverse effect profile for all forms of PE. Until then, it is wise to remember that no oral medication in isolation will entirely replace the need for compassionate patient counseling, coordinating treatment of the genital function aspects of PE with the management of the often highly charged psychosocial and partnership issues attendant to this condition.

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Corresponding Author: Hossein Sadeghi-Nejad, MD, FACS, UMDNJ New Jersey Medical School—Surgery, Division of Urology, 185 South Orange Ave., MSB G 536, Newark, NJ 07103-2714, USA. Tel: (973) 972- 4488; Fax: (973) 395-7197 Conflict of Interest: Dr. Sadeghi-Nejad is a speaker for Pfizer, and is an investigator in a clinical trial sponsored by Plethora Solutions. Lue T, Broderick G. Evaluation and nonsurgical management of erectile dysfunction and premature ejaculation. Selective serotonin reuptake inhibitor-induced sexual dysfunction: clinical and research considerations. Utility of selective serotonin reuptake inhibitors in premature ejaculation. Curr Opin Invest Drugs 2004;5:743–7. Safarinejad MR. Safety and efficacy of escitalopram in the treatment of premature ejaculation: A doubleblind, placebo-controlled, fixed-dose, randomized study. Giuliano F, Clement P. Serotonin and premature ejaculation: From physiology to patient management. Clomipramine and sexual function in men with premature ejaculation and controls. Giuliano F.

Other Therapy

Prevalence of chronic prostatitis in men with premature ejaculation. Effects of a new type of 5-HT receptor agonist on male rat sexual behavior. Pharmacol Biochem Behav 1981; 15:785–92. The role of the 5-HT2 receptor in the regulation of sexual performance of male rats. Waldinger MD, Berendsen HH, Blok BF, Olivier B, Holstege G. 5-Hydroxytryptamine in premature ejaculation: Opportunities canada sildenafil for therapeutic intervention. Giuliano F. Interview with Dr Francois Giuliano (by Christine McKillop). New avenues in the pharmacological treatment of premature ejaculation. Relevance of an evidence-based ejaculation time cutoff point for neurobiological research of premature ejaculation. Animal models of premature and retarded ejaculation. Waldinger MD, Schweitzer DH, Olivier B.

MeSH terms

In: Walsh PC, Retik AB, Vaughan ED, Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peters CA, eds. Comparison of efficacy of sildenafilonly, sildenafil plus topical EMLA cream, and topical EMLA-cream-only in treatment of premature ejaculation. Colpi GM, Fanciullacci F, Beretta G, Negri L, Zanollo A. Evoked sacral potentials in subjects with sildenafil citrate 100 mg true premature ejaculation. ISSM announces new definition of premature ejaculation.

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International Society of Sexual Medicine Newsbulletin 2007;24:6. Available at 24.pdf (accessed March 24, 2008). Jannini EA, Lenzi A. Ejaculatory disorders: Epidemiology and current approaches to definition, classification and subtyping. Sexual dysfunction in the United States: Prevalence and predictors. On-demand SSRI treatment of premature ejaculation: Pharmacodynamic limitations for relevant ejaculation delay and consequent solutions. J Sex Med 2005;2:121–31. Peripheral and central neurochemical effects of the selective serotonin reuptake inhibitors (SSRIs) in humans and nonhuman primates: Assessing bioeffect and mechanisms of action. Sprouse J, Braselton J, Reynolds L, Clarke T, Rollema H. Activation of postsynaptic 5-HT(1A) receptors by fluoxetine despite the loss of firingdependent serotonergic input: Electrophysiologicaland neurochemical studies. Sprouse J, Clarke T, Reynolds L, Heym J, Rollema H. Comparison of the effects of sertraline and its metabolite desmethylsertraline on blockade of central 5-HT reuptake in vivo. Anderson GM, Barr CS, Lindell S, Durham AC, Shifrovich I, Higley JD. Time course of the effects of the serotonin-selective reuptake inhibitor sertraline on central and peripheral serotonin neurochemistry in the rhesus monkey. Waldinger MD, Zwinderman AH, Olivier B.

Parameter	Data	Notes
Tolerance development	Rare, possible with prolonged use	Monitoring advised
Dependency risk	Low	Not considered addictive
Long-term side effects	Unclear, ongoing research	Regular medical check-ups recommended
Impact on cardiovascular health	Generally safe in healthy individuals	Caution in pre-existing cardiovascular conditions

On-demand treatment of premature ejaculation with clomipramine and paroxetine: A randomized, double-blind fixed-dose study with stopwatch assessment. Eur Urol 2004;46:510–5; discussion 516. Modi NB, Dresser MJ, Simon M, Lin D, Desai D, Gupta S. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: An integrated analysis of two double-blind, randomised controlled trials. McMahon CG, Touma K.

• Premature ejaculation affects about 30% of men.
• Psychological factors often contribute to PE.
• Behavioral therapies can help manage PE.
• Topical anesthetics are alternative treatments for PE.
• SSRI antidepressants are commonly prescribed for PE.
• Combining sildenafil with PE drugs requires care.
• Lifestyle changes like exercise may improve PE.
• Stress and anxiety can trigger premature ejaculation.
• Delay techniques include the stop-start method.
• Medical treatments should be personalized for each patient.
• Education about sexual response can reduce PE.

Treatment of premature ejaculation with paroxetine hydrochloride as needed: 2 single-blind placebo controlled crossover studies.

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