The International Society for Sexual Medicine's Process of Care for the Assessment and Management of Testosterone Deficiency in Adult Men

Abstract

Introduction In 2014, the International Society for Sexual Medicine (ISSM) convened a panel of experts to develop an evidence-based process of care for the diagnosis and management of testosterone deficiency (TD) in adult men. The panel considered the definition, epidemiology, etiology, physiologic effects, diagnosis, assessment and treatment of TD. It also considered the treatment of TD in special populations and commented on contemporary controversies about testosterone replacement therapy, cardiovascular risk and prostate cancer. Aim The aim was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of diagnosis and management of TD for clinicians without expertise in endocrinology, such as physicians in family medicine and general urology practice. Method A comprehensive literature review was performed, followed by a structured, 3-day panel meeting and 6-month panel consultation process using electronic communication. The final guideline was compiled from reports by individual panel members on areas reflecting their special expertise, and then agreed by all through an iterative process. Results This article contains the report of the ISSM TD Process of Care Committee. It offers a definition of TD and recommendations for assessment and treatment in different populations. Finally, best practice treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with TD. Conclusion Development of a process of care is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to new insights into the pathophysiology of TD, as well as new, efficacious and safe treatments. We recommend that this process of care be reevaluated and updated by the ISSM in 4 years.

Controversies in the diagnosis and management of testosterone deficiency syndrome

“…The Canadian guideline advises a threemonth trial of treatment, 1 as also recommended in the Endocrine Society guideline. 5 In line with the International Society for Sexual Medicine guideline, 3 I suggest that clinicians consider a minimum period of six months when assessing response. In a randomized controlled trial of testosterone undecanoate in men with type 2 diabetes, my colleagues and I showed that improvement continued until six months, and even extended to 12 months in some patients.…”

“…Given the ongoing controversy and changes in our understanding of testosterone deficiency, it is not surprising that there are multiple guidelines available from other developers, including recent updates from the European Association of Urology 2 and the International Society for Sexual Medicine. 3 The guideline from the Canadian Men's Health Foundation 1 provides recommendations specifically for Canadian physicians and is largely consistent with the 2008 International Society for the Study of the Aging Male 4 and 2010 Endocrine Society guidelines. 5 The current guideline will be a useful resource for Canadian physicians, but although research studies are bringing clarity to some aspects of caring for patients with testosterone deficiency syndrome, there are still many for which there is no consensus.…”

“…The European Association of Urology and the International Society for Sexual Medicine set parameters that men with a total testosterone level of less than 8 nmol/L will usually benefit from treatment and that a trial of therapy may be indicated for those with levels between 8 and 12 nmol/L in the presence of substantial symptoms. 2,3 Although experts could argue about these levels, the levels do, at least, provide a basis for primary care management and remove the mystique that only an eminent endocrinologist can really diagnose "true" testosterone deficiency. Canadian physicians may find these specific levels helpful as a guide in diagnosis.…”

BSSM guidelines on testosterone deficiency: a summary

“…Testosterone therapy is appropriate for treating ED, particularly at TT levels <8nmol/L, 4,7 and for salvaging ED treatment failures with oral medication, particularly at TT levels <10.4 nmol/L. 24 It also reduces the need for more invasive and expensive second-and third-line ED treatments in …”

“…5 The condition is characterised by a deficiency in serum androgen levels, with or without decreased genomic sensitivity to androgens, 6 and relevant signs and symptoms. 5,7 Epidemiology of TD There is wide variation in the estimated prevalence of TD. The European Male Aging study evaluated more than 3000 men between 40-79 years of age according to biochemistry and symptoms, defining the syndrome of TD as the presence of three or more sexual symptoms associated with a total testosterone (TT) level less than 11 nmol/L, and a free testosterone (FT) level less than 0.22 nmol/L.…”