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Knowledge Gaps and Uncertainties

Currently there are several knowledge gaps in the management of ED. There is still insufficient information regarding the effectiveness and safety related to the use of different treatment modalities in various clinical subgroups of patients (e.g. diabetes, cardiovascular disease). Furthermore, there is insufficient data with regard to long-term adverse effects of oral ED medications that have been used by millions of users for over a decade. Comparative data on the efficacy and safety profiles of PDE-5 drugs have not yet been accumulated. Safety and efficacy data from trials with head-to-head comparisons of PDE-5 drugs are needed to establish the relative superiority of one drug over the others.

Some controversy has surrounded the issue of the clinical utility of and indications for routine endocrinological blood tests (e.g.testosterone, prolactin) for all patients presenting with ED.19, 20, 37, 38 Current American Urological Association Practice Guidelines Committee (AUA PGC) recommend the determination of hormone levels based on initial clinical assessment or failure of initial PDE-5 management; these tests are not mandatory for all patients.14 This is in contrast to the guidelines of the European Urological Association and the British Society for Sexual Medicine, both of which define endocrinological “screening” as a mandatory component of the initial evaluation of ED.39 The purpose of this testing is to identify and treat endocrinopathies such as hypogonadism and hyperprolactinemia as underlying causes of ED. In these cases, therapeutic outcomes for hormonal disorders and resultant ED are thought to be optimized.20, 40 The debate regarding the optimal approach still continues. One group of experts recommends basic endocrine screening to measure serum levels of testosterone and prolactin, to guide treatment of the patients with testosterone and its analogs to correct specific endocrinopathies and symptoms of ED, 4143 as well as to detect pituitary tumors.38, 44 Other experts do not recommend the administration of routine hormone tests to all ED patients because of the high cost of these tests and the low prevalence of endocrinopathies in the ED population.20, 37, 45 These authors suggested that the screening tests for serum hormonal levels be restricted to those patients with clinical signs of hypogonadism (e.g. decreased libido, small testes, reduced body hair) as revealed by a physical examination, or to those in whom the initial PDE-5 inhibitor therapy was ineffective.20, 38, 45 Authors of one empirical study advocated routine determination of serum testosterone levels for all ED patients older than 50 years and serum prolactin levels for only those with low testosterone levels (< 4ng/mL), decreased libido, and/or gynecomastia.38. Clearly, a universally accepted guideline of “standard of practice” for endocrinological testing of the ED patient is yet to be defined and established.

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