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We examine the progress that has been made towards the development of topical treatments for premature ejaculation (PE). Although generally regarded as one of the most common male sexual problems, the lack of approved pharmacological agents for PE means that treatment options are limited to behavioural therapy, where available, and the use of drugs 'off-label'. There are various theories on the aetiology of PE, but it seems likely that both biological and psychological factors are important. One theory, that men with PE might have a heightened sensory response to penile stimulation, provides the rationale for using topical therapy; reducing the sensitivity of the glans penis with topical desensitizing agents (e.g. local anaesthetics) might improve ejaculatory latency without adversely affecting the sensation of ejaculation. Off-label topical treatments are now relatively widely used, despite limited supportive efficacy data. There are also new topical treatments in various stages of development, designed specifically for use in PE. Treatments reviewed include TEMPE spray, containing a eutectic mixture of the topical anaesthetics lidocaine and prilocaine, and several creams, including one containing natural products (SS-cream), and preliminary results from another containing the local anaesthetic dylonine, with alprostadil (prostaglandin E1). Despite wide variations in the methods of clinical trials, it is possible to conclude that all placebo-controlled studies of topical treatments have reported a significant increase in intravaginal ejaculatory latency time compared to baseline and placebo. Topical treatments for PE are appealing in that they can be applied as needed and only minimal systemic effects are likely. However, without well-controlled drug delivery there is the theoretical possibility of penile hypoaesthesia and/or transvaginal contamination. Unlike the cream formulations, the TEMPE spray has a well-controlled delivery system, making it easy to administer locally, and it appears to be well tolerated in early clinical trials. It appears that topical treatments might be able to satisfy many of the requirements of an ideal treatment for PE, and certainly have the potential for use as a first-line treatment. more...

The efficacy and the tolerability of extended-release oxybutynin chloride, 10 mg daily, and extended-release tolterodine tartrate, 4 mg daily, in women with or without prior anticholinergic treatment for overactive bladder (OAB) were compared in a post-hoc analysis of data from the Overactive Bladder: Performance of Extended Release Agents (OPERA) trial. The patient population and study methods have been described previously (Diokno et al., for the OPERA Study Group, Mayo Clin Proc 78:687-695, 2003). Among the group with anticholinergic experience, extended-release oxybutynin was significantly more effective than extended-release tolterodine in reducing micturition frequency at last observation (p=0.052). Complete freedom from urge incontinence was reported by significantly more patients taking oxybutynin than tolterodine at last observation (23.6 vs 15.1%, p=0.038). In addition, among patients completing a full 12 weeks of oxybutynin treatment, significantly greater reductions were observed compared with those taking tolterodine on the primary efficacy variable, number of urge incontinence episodes (p=0.049), and the combined total of urge and non-urge episodes (p=0.012), although the differences between treatment groups were not significant at last observation. In the anticholinergic-naïve group, efficacy and tolerability outcomes were similar across treatments, except that oxybutynin was associated with a significantly lower frequency of micturition at last observation (p=0.035). No efficacy differences favoring tolterodine were observed, and tolerability of the treatments was comparable. Dry mouth (mostly mild to moderate in severity) was reported significantly more often among participants taking extended-release oxybutynin than extended-release tolterodine (32.2 vs 19.2%, p=0.004), but only among those with previous anticholinergic experience. Discontinuation rates were comparably low across groups. The results demonstrate the appropriateness of initiating treatment for OAB with extended-release oxybutynin, particularly in women presenting with incontinence. more...

Aim: This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED., Methods: A total of 1,911 patients with ED were enrolled into eight predefined groups: (1-3) Caucasian (Reference group), Black American, or Hispanic patients, < or =65 years of age with no diabetes mellitus or depression; (4) patients with depression, < or =65 years of age, no diabetes; (5) patients with diabetes, < or =65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP)., Results: Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1-5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain., Conclusion: Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial. more...

Background: Although premature ejaculation (PE) is a common male sexual dysfunction, its relevant parameters have not been adequately studied in large community-based samples., Objective: To examine the diagnostic utility of two self-report questions based on the DSM-IV-TR definition of PE and to investigate the relationship between self-identified PE, sexual functioning, and sexual satisfaction in men., Methods: An Internet survey of general health and aspects of sexual functioning and satisfaction was conducted in 2,056 males. Subjects were classified as having "probable" or "possible" PE, or as "non-PE" by survey responses., Results: A total of 1158 men met the selection criteria (sexually active in a stable heterosexual relationship), and 189 (16.3%) were classified as having probable PE by reporting they ejaculated before they wished and indicating it was "very much" or "somewhat" a problem. Another 188 (16.2%) men reported ejaculating before they wished but rated their distress lower and were classified as having possible PE. Compared to non-PE men, those with probable and possible PE reported significantly worse sexual functioning in 6 of 8 study measures. Concern about partner satisfaction was high in all groups. The importance of ejaculatory control and the ability to have intercourse for the desired time was significantly higher in men with PE as compared to non-PE men (P < 0.01)., Conclusions: PE was a common problem, was characterized by a lack of ejaculatory control, and was associated with significant effects on sexual functioning and satisfaction. Additional research on the sensitivity and specificity of these self-report questions should be pursued. more...

Introduction: Penile prostheses, introduced as the first effective organic treatment for erectile dysfunction over three decades ago, have an important role in the treatment of erectile dysfunction when other nonprosthetic treatment options have proven unsatisfactory. Although they are the least chosen and most invasive treatment option, they have the highest satisfaction rate of all available ED options and provide a predictable and reliable result., Aim: To provide recommendations/guidelines concerning state-of-the-art knowledge for utilization of the penile prosthesis in the management of men with erectile dysfunction., Methods: An International Consultation in collaboration with the major sexual medicine associations assembled over 200 multidisciplinary experts from 60 countries into 17 committees. Committee members established specific objectives and scopes for various sexual medicine topics. The recommendations concerning state-of-the-art knowledge in the respective sexual medicine topic represent the opinion of experts from five continents developed in a process over a 2-year period. There were 10 experts from seven countries concerning the Penile Implant for Erectile Dysfunction., Main Outcome Measure: Expert opinion was based on grading of evidence-based medical literature, widespread internal committee discussion, public presentation and debate., Results: Recommendations/guidelines for penile prosthesis (hydraulic, semi-rigid and soft silicone) insertion for management of men with erectile dysfunction were updated. Consensed issues included: criteria for patient selection, informed consent procedures, strategies for preoperative preparation, operative incisions/technical considerations and outcome results in terms of patient satisfaction and device survival. Updated information was reviewed concerning therapies for device failures, device insertion in scarred corporal bodies and strategies for managing implant infections., Conclusions: There is a need for more research in developing management strategies for insertion of penile prostheses in men with ED. more...

It seems naïve to believe that some plants or herbs do not contain specific compounds that could benefit patients with ED. Many supplements have not been investigated in a laboratory or clinical research setting before commercial sale, however,which creates a complex situation. If efficacy is or is not demonstrated through adequate research, then the benefit or lack thereof cannot be mentioned on the label. Furthermore, clinicians and the public cannot be made aware of which compounds or supplements are effective because no general standards for sale exist under the current guidelines. Dietary supplements have received a tremendous amount of publicity. The large and growing market for ED treatment seems to have contributed partly to the promotion of numerous supplements and their apparent benefits. Whether these dietary supplements have merit is questionable. Some supplements may produce results opposite to those advertised. Other supplements may be enjoying the benefits of the placebo effect. Because a placebo response of 25% to 50% has been recorded in clinical trials with effective agents, it is understandable that some supplements enjoy financial success despite the limited research espousing their use. If one to two of four individuals or one of three individuals who try a dietary supplement gain some benefit for their ED, the market for these supplements will remain extraordinary. On a larger scale, of 100,000 men who try a supplement, approximately 25,000 to 50,000 will claim some success. The challenge for clinicians is to discuss the placebo response properly and the need for good research before any intervention, especially supplements, can be advocated for general use. Table 2 summarizes some popular ED supplements and general conclusions that can be drawn from clinical investigations. Some dietary supplements may have an active ingredient that benefits patients with certain types of ED. An exciting area of future dietary supplement research is the ability of certain agents to have a synergistic effect with prescription agents for ED, thereby improving response rates in men that have failed approved ED therapy initially, especially with oral agents. Randomized clinical trials are the best method of determining which dietary supplements will become a part of conventional medicine. Therefore, more randomized trials for dietary supplements are needed so that they may have the opportunity to become a part of the mainstream milieu, which means that more funding needs to be made available for ED research. The coming years of research should bring enormous excitement and objectivity to this area of medicine. more...

Clinicians working in urology should adhere to the same guidelines that are observed in cardiovascular medicine when dealing with a patient with ED. A golden opportunity exists to discuss lifestyle changes with any man with or concerned about ED. Providing heart-healthy recommendations to men with minimal to extensive ED may produce a twofold impact: (1) patients may be able to affect the future extent of their disease, and (2) patients may become healthier overall. Patients following a heart-healthy lifestyle after a diagnosis of ED or to prevent ED should enjoy increased quality or quantity of life. The time is more than ripe for patients to understand that heart health is tantamount to erectile health. more...

The evaluation and treatment of erectile dysfunction (ED) differs from that of many medical conditions. An intimate dialogue between the patient and physician must be established for accurate assessment of ED severity and successful therapy. Patient and partner education on the nuances of oral phosphodiesterase inhibitor therapy is important to maximize treatment success with this currently first-line therapy. Realistic expectations for the erectile response and patience are necessary to resume satisfactory sexual functioning. Relationship issues or partner resistance can contribute to a suboptimal erectile response to therapy, in which case the patient may benefit from sexual therapy referral. more...

Since its approval in 1998, sildenafil citrate (Viagra) has been shown to be efficacious in >100 clinical trials involving >8000 men with erectile dysfunction (ED). In clinical practice, however, many men do not continue long-term use of sildenafil for a variety of reasons; thus, 6 different aspects of optimizing treatment with sildenafil are described here. (1) Intercourse success rates, considered a reflection of real-world effectiveness, were assessed in 1276 patients with ED. Results indicated that the cumulative probability of achieving intercourse success with sildenafil increased with the number of attempts, reaching a plateau after approximately 8 attempts. (2) A comprehensive disease management approach that included a medical history, physical examination, educational material about ED, modifications of risk factors/lifestyle changes, and counseling resulted in successful intercourse in 74% of 111 patients taking sildenafil. (3) A survey conducted among primary care physicians revealed that almost 50% did not routinely question their patients about ED symptoms, although it is known that most patients would prefer their physician to take the initiative. (4) Overall, 55% of 137 men who were previously not successful with sildenafil became successful after reeducation and counseling, which included information on patient and partner expectations, how to properly take the drug, titration to maximum dose, and a minimum trial of 8 attempts for efficacy assessment. (5) Many men with ED have underlying comorbidities or take multiple medications that are risk factors for ED. Controlling these risk factors in 521 men from a multispecialty clinic led to an overall intercourse success rate of 82%; patients with multiple risk factors were less likely to have intercourse success than men with only 1 risk factor. (6) Finally, treatment satisfaction is a pivotal factor in maintaining long-term ED therapy. In an open-label trial, 82% of 443 subjects reported treatment satisfaction with sildenafil. In summary, these findings highlight how important it is for physicians to take a more comprehensive, proactive approach when treating men with ED, including control of risk factors, instructions on how to properly take the drug, partner involvement, and follow-up visits. Using these recommended measures, most men with ED, including those whose treatment was previously unsuccessful, can be treated successfully with sildenafil. more...