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Novel treatment modalities currently being evaluated for ED include: topical alprostadil, dopamine agonists, melanocortins, Rho-kinase inhibitors, guanylate cyclase activators, as well as in vivo and ex vivo gene therapy.

Alprostadil, which is formulated with SEPA gel or NexAct (both are topical absorption enhancing substances) is in phase 3 clinical studies and has shown improvements in erectile function, but it is unclear when or if this agent will be commercially available. Bremelanotide is a melanocortin receptor agonist with known effects on erectile function originating within the CNS and has shown significant improvements in erectile response after intranasal administration. 36 The active form of Rho-kinase appears to augment the regulation of cavernosal smooth muscle contraction and detumesence, therefore, compounds that inhibit Rho-kinase are currently under development. 34 The potential application of genetic technology, although still in early development, holds the most promise for the future of ED management. In animal studies testing intracavernous injections of a 'naked' DNA plasmid genetically encoded with a potassium channel activator, hSlo, the treatment has slowed the natural decline and maintained erectile function in rats for several months.

36,37 A phase 1 study demonstrated a complete return of erectile function in 2 of 11 men with ED who received hSlo intracavernous therapy, which was well tolerated, as reported in a 2-year follow-up study.

ED encompasses several disorders related to problems with ejaculation, such as premature ejaculation, delayed ejaculation, and anorgasmia. 5 Of these, premature ejaculation is the most common and the focus of this discussion.

Premature ejaculation can be subdivided into a primary or secondary disorder, and although the underlying etiology is not completely known, accumulating evidence supports the role of a neurophysiologic and/or behavioral disease component.

5,7,40 Patients with primary premature ejaculation (PPE) have features consistent with a neurophysiologic focus including family history of PE, penile hypersensitivity, excessive ejaculatory reflex, and serotonin receptor sensitivity.

40 Stress, anxiety, and emotional problems are consistent with a behavioral theory and have been more closely associated with secondary PE. Several neurotransmitters have been implicated for their role in the complex process of the ejaculatory reflex, with serotonin exhibiting an inhibitory role during ejaculation. A complete assessment of sexual function should be evaluated in order to differentiate ED from PE, which has been reported to co-occur in approximately 30% of patients.

40 Complaints involving difficulties maintaining an erection as a result of early ejaculation in the absence of comorbid wholesale viagra pills ED factors could be misdiagnosed as ED if a patient is not properly screened for PE. A short intravaginal ejaculatory latency time (IELT), which is the time from vaginal penetration to ejaculation, can be helpful in establishing the underlying etiology of sexual dysfunction.

Recently, the Premature Ejaculation Tool, a valid and reliable measure of premature ejaculation, was developed to capture patient concerns beyond a short latency time.

Although several drugs have been evaluated in clinical trials to improve ejaculatory control and reduce personal distress, none of these agents are currently approved by FDA for the treatment of PE. However, behavior modification strategies and pharmacologic agents such as the

selective

5 Topical anesthetics effectively desensitize the penis to tactile stimuli, improve latency time, and are associated with only minor local side effects.

The SSRIs and TCAs have traditionally been used as antidepressants and some are associated with intolerable side effects and potentially significant drug interactions, therefore the chronic use of these drugs for the treatment of PE can be unappealing and may result in poor adherence by patients.

To address these concerns, several clinical trials have utilized lower doses and on-demand versus continuous daily dosing of these agents, but an advantage associated with this dosing strategy has not been clearly established.

Paroxetine, sertraline, and fluoxetine have been the most studied SSRIs and are commonly recommended agents for the management of PE within their class. Based on results from several randomized controlled trials, paroxetine seems to have the greatest effect on improving IELT and delaying ejaculation from 1.5 min before treatment to 7.7 min after treatment.

40,41 Sertraline and fluoxetine have also been shown to increase IELT and improve patient satisfaction, compared to placebo, although fluoxetine's long half-life lends itself to continuous daily dosing rather than on-demand administration.

The studies that have evaluated the SSRIs for the treatment of PE have generally found these agents to be well tolerated overall, particularly with trials involving patients receiving on-demand treatment.

Some of the more commonly reported side effects predominantly occurring in patients on continuous dosing include: nausea, fatigue, headache, confusion, and diarrhea. To minimize potentially serious adverse reactions, patients taking SSRIs should be instructed to avoid taking other serotonergic drugs and advised against abruptly discontinuing therapy. Furthermore, healthcare providers should monitor patients closely for drug interactions, because several SSRIs are highly protein bound and metabolized through the cytochrome P450 system.

Clinical trials evaluating the TCAs for the treatment of PE have focused primarily on clomipramine which has been shown to have favorable effects on IELT in several studies.

5 In a randomized crossover design involving 36 men with PE who were treated with fluoxetine, sertraline, clomipramine, and placebo, clomipramine had the greatest effect on IELT (from 46 sec at baseline to 5.75 min, P 43 Anticholinergic side effects such as drowsiness, dizziness, dry mouth, and fatigue have been reported in clomipramine-treated patients and may necessitate discontinuation of therapy; on-demand dosing may minimize these effects and improve patient tolerability. Compared to the array of prospective treatment modalities being studied for patients with erectile dysfunction, future investigational agents for patients with PE to date have not been as promising. The lack of currently approved treatment options by the FDA has further called into question the chronic continuous use of current agents which are viewed as having a questionable cheap viagra prescription risk-to-benefit ratio for the management of PE. Despite these challenges, several agents are being investigated for PE including: SSRIs, serotonin receptor (5-HT 1A ) antagonists, opioid receptor agonists, PDE 5 inhibitors, and topical preparations.

Dapoxetine, a rapidly absorbed SSRI with a short half-life, has received the most attention of the investigational agents for PE.

Despite receiving a non-approvable letter from FDA in 2005, dapoxetine is in phase 3 studies and is currently available in several European countries.

Unfortunately the SSRIs BMS-505130 and UK-390957, which had shown some initial promise, no longer appear to be under development.

44 The proposed rationale behind the development of the 5-HT 1A antagonists for PE is that the coadministration of these agents with the SSRIs may improve the onset of effect in patients who are utilizing on-demand treatment. Combination treatment with pindolol (a non-selective beta blocker with known 5-HT 1A antagonist properties) and paroxetine was shown to improve IELT, weekly intercourse episodes, and satisfaction in PE patients who were refractory to paroxetine monotherapy. 45 However, combination therapy was also associated with significantly more side effects, which is consistent with the poor tolerability of non-selective beta blockers.

Despite several studies that have evaluated the use of sildenafil, vardenafil, or tadalafil, substantial data to support the efficacy of these agents in men with PE, who do not have coexisting ED, is lacking. Other currently available agents that have received attention or have limited data for the treatment of PE include tramadol and alpha adrenergic antagonists such as alfuzosin and terazosin.

Finally, clinical research focused on topical preparations that have novel delivery formulations, such as a lidocaine/prilocaine metered dose aerosolized spray continue to receive attention because they have demonstrated efficacy and are well tolerated by most patients. The prompt recognition and management of underlying organic, neurogenic, and psychogenic conditions associated with ED are necessary to improve treatment-related outcomes.

Phosphodiesterase inhibitors have now replaced generic viagra soft tabs online older agents such as alprostadil, phentolamine, and papaverine for the first-line treatment of ED.

The convenience of these oral dosage forms, which have been available for the past decade, has also generated the willingness of more men to seek earlier treatment for their symptoms.

Although premature ejaculation remains one of the most common sexual disorders, the lack of FDA-approved treatments has proven to be a significant challenge for the management of this condition.

Despite this obstacle, several agents are currently recommended by the AUA for the treatment of PE such as SSRIs, TCAs, and topical lidocaine/prilocaine.

Several investigational drugs for the management of ED and PE are also in various phases of development.

Douglass is assistant clinical professor, Northeastern University School of Pharmacy, Adult Internal Medicine, Boston Medical Center, Mass. Lin is a urologist at Massachusetts Bay Urologic Associates, Dorchester Center, Mass.

Disclosure Information: The authors report no financial disclosures as related to products discussed in this article. Management of erectile dysfunction: diagnosis and treatment guideline.

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Efficacy of type-5 phosphodiesterase inhibitors in the drug treatment of premature ejaculation: a systematic review. Although it may feel uncomfortable to take that first step and see a doctor, there are many treatments available today that can restore erectile function, allowing patients to return to sexual activity. Conservative treatment often begins with pills (such as “the blue pill,” Viagra and Cialis) and penile injections. But, what happens if pills and injections don’t work for you? At The Institute for Advanced Reconstruction, we may be able to restore erectile function by performing super active viagra 150 mg a minimally invasive nerve transfer procedure. Erectile dysfunction (ED), also known as impotence, is a common male sexual dysfunction defined as an inability to achieve or sustain an erection.