The Position Statements are listed below. Please click on any of the titles below to view the statements.
Surgical and non-surgical treatments of sexual dysfunction should be standard benefits of all medical insurance programs
The Sexual Medicine Society of North America (SMSNA) believes that treatment of sexual dysfunction is an essential and necessary element of good healthcare and produces significant improvements not only in sexual function but also in overall health, work productivity and life satisfaction. SMSNA strongly supports the concept that all standard treatments for sexual dysfunction, including implantation of penile prostheses, should be covered by Medicare and other medical insurance programs.
Many good quality scientific studies clearly demonstrate the safety, efficacy and value of standard treatments of sexual dysfunction in men and women.
In general, medical insurance programs grant benefits for treatments that are medically necessary. Medically necessary services are often defined as treatments which replace, improve or restore a dysfunctional, missing or impaired body part. Examples of non-life-threatening conditions which are routinely granted medical insurance benefits are breast reconstruction after treatment for breast cancer, bariatric surgery for treatment of obesity, genital reconstructive surgery for treatment of transgender conditions and joint replacement for treatment of pain and disability due to arthropathy.
The most commonly treated sexual dysfunction is erectile dysfunction (ED). ED is not primarily a psychological problem although there are significant secondary psychological effects of ED. ED is usually a physical problem, which is very often caused by diabetes mellitus, treatments for prostate cancer, hypertension, dyslipidemia, vasculopathy, smoking and various forms of cardiovascular disease. There are several safe and effective treatments for ED due to these conditions. These treatments include oral therapy with PDE5 inhibitors, intracavernous injections, intraurethral prostaglandin, vacuum therapy and implantation of penile prostheses.
SMSNA believes that treatments for ED, as well as other forms of sexual dysfunction, fit the definition of medical necessity and should be routine benefits of medical insurance programs. Treatment of sexual dysfunction is as deserving of insurance benefits as reconstructive breast surgery, transgender reconstructive genital surgery and other conditions which compromise quality of life. SMSNA believes that it is inconsistent for medical insurance benefits to be denied for treatment of sexual dysfunction, which may have a devastating effect on quality of life but granted for breast and genital reconstruction and other dysfunctions which are not life-threatening. When ED is due to prostate cancer treatments, diabetes mellitus and other underlying conditions, SMSNA strongly supports the provision of medical insurance benefits for all standard treatments, including implantation of penile prostheses.
Sexual side effects of treatment for benign prostatic hyperplasia (BPH) are often a distressing problem for patients and/or their sexual partners. Until recently, virtually all treatments for BPH have been associated with risks of erectile dysfunction and/or ejaculatory dysfunction. Pharmacologic therapy for BPH provides modest improvement in urinary function but up to 30% of patients discontinue treatment because of insufficient improvement in urinary symptoms and/or bothersome side effects, including sexual dysfunction. Surgical therapy for BPH provides better levels of improvement in urinary function but also higher levels of sexual dysfunction. Studies show that 3 to 14% of men suffer from erectile dysfunction and 30 to 80% suffer from ejaculatory dysfunction after surgical treatment for BPH.
New FDA-approved methods for treatment of BPH have shown significant benefits to urinary function without sexual side effects, making these new treatment options very attractive for sexually active men who need surgical treatment for BPH. One of these treatments is the cystourethroscopic insertion of permanent adjustable transprostatic implants, which is also known as the Urolift® prostatic urethral lift procedure. In two key publications,1,2 the incidence of erectile and ejaculatory dysfunction after adjustable transprostatic implants was zero. Another method for treatment of BPH is transurethral needle ablation of the prostate using water vapor convective thermal energy, which is also known as WAVE or Rezum®. In a randomized, controlled study,3 there was significant improvement in urinary function and no de novo erectile or ejaculatory dysfunction after water vapor convective thermal energy.
The Sexual Medicine Society of North America (SMSNA) acknowledges the Urolift® prostatic urethral lift procedure and the Rezum® transurethral needle ablation of the prostate using water vapor convective thermal energy as options for the treatment of BPH. Given their favorable sexual side effect profile over alternative therapies, the SMSNA recommends that they be recognized and considered as a viable treatment option in men with symptomatic BPH.
1. Woo HH, et.al. Preservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med 2012;9:568-575
2. Roehrborn CG, et. al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol 2013;190:2161-2167
3. McVary KT, Gange SN, Gittelman MC, et al. Erectile and ejaculatory function preserved with convective water vapor energy treatment of LUTS secondary to BPH: randomize controlled study. J Sex Med 2016;13:924-933.
In August 2015, a colloquium of experts commissioned by the Sexual Medicine Society of North America (SMSNA) convened in Washington, DC, to discuss the common clinical scenario of men who present with low testosterone (T) and associated signs and symptoms accompanied by low or normal gonadotropin levels. This syndrome is not classical primary (testicular failure) or secondary (pituitary or hypothalamic failure) hypogonadism because low T may be the result of both testicular and pituitary-hypothalamic failure. The Panel designated this syndrome Adult Onset Hypogonadism (AOH) because it occurs commonly in men of middle-age and older.
The Panel consisted of 17 experts in men’s health, sexual medicine, urology, endocrinology, and methodology. All colloquium participants declared potential conflicts of interest; participants were both members and non-members in the SMSNA. The Panel deliberated regarding a rigorous diagnostic process to document signs and symptoms of AOH, the rationale for treatment with T, and a monitoring protocol for T-treated patients.
The SMSNA recognizes that the evaluation and management of hypogonadal syndromes have been addressed in recent publications (i.e., the Endocrine Society, Bhasin et al., 2010; the American Urological Association, Paduch et al., 2013; the International Society for Sexual Medicine, Dean et al., 2015). The primary purpose of this document is to support health care professionals in the development of a deeper understanding of AOH, particularly in how it differs from classical primary and secondary hypogonadism, and to provide a conceptual framework to guide its diagnosis, treatment, and follow-up.
Consensus statement: AOH is a measurable syndrome characterized by low T, associated symptoms, and low or normal gonadotropin levels. Men with AOH who are candidates for treatment with T should be counseled regarding the benefits and risks of treatment. Patients who are treated should be monitored regularly.
Section 1: Conceptualization of AOH.
AOH is a clinical and biochemical syndrome characterized by a deficiency of T with symptoms and signs that can be caused by testicular and/or hypothalamic-pituitary (HP) dysfunction; AOH is therefore clinically distinct from classical primary and secondary hypogonadism. This syndrome is characterized by T deficiency and the failure to mount an adequate compensatory pituitary response to low T levels; gonadotropin levels are low or in the normal range.
AOH is well-illustrated by hypogonadal men in the European Male Ageing Study (EMAS) (Tajar et al., 2010; see Figure 1). Approximately 2.0% of men had primary hypogonadism (low T, high LH), 9.5% had “compensated” hypogonadism (normal T, high LH), and 11.8% of men were classified as having secondary hypogonadism with low T accompanied by low or normal LH – a presentation consistent with AOH.
Figure 1. Subgroups of men by gonadal status and by decade of age from the European Male Ageing Study (EMAS) (Tajar et al., 2010).
In the EMAS study, the prevalence of hypogonadism was 13.8%; of these men, 85.5% were classified as having secondary hypogonadism (Tajar et al., 2010). Similar prevalences of secondary hypogonadism have been reported among men seeking care for sexual dysfunction (Guay et al., 2010; Maseroli et al., 2015).
Importantly, among men with secondary hypogonadism in the EMAS sample, only 11% had a specific medical condition (e.g., genetics, surgery, radiotherapy, trauma) that could account for the hypogonadism; the etiology in the remaining 89% was unknown (Corona & Maggi, 2015). The term AOH could be applied to the overwhelming majority of these men, many of whom also had concomitant metabolic disease (i.e., obesity, type 2 diabetes, or metabolic syndrome).
Hypogonadism prevalence in general may increase with age (e.g., the Baltimore Longitudinal Study of Aging, BLSA, Harman et al., 2001). The prevalence may be higher among men ≥ 65 years of age although prevalence rates by decade up to age 84 have been reported as statistically indistinguishable (range 34% to 45.5%) (Mulligan et al., 2006). Patterns are similar when symptoms are considered. In the Massachusetts Male Aging Study (MMAS), symptomatic AD prevalence was similar for men aged 40 to 49 years (4.1%) and 50 to 59 years (4.5%) but was increased among men aged 60 to 70 years (9.4%) (Araujo et al., 2004). In the Boston Area Community Health (BACH) study prevalence rates of symptomatic AD by decade among men aged 30 to 69 years ranged from 3.1% to 7.0% and were statistically indistinguishable; the prevalence rate for men aged 70 to 79 years, however, was 18.1% (Araujo et al., 2007). Some studies suggest that AOH, unlike overall hypogonadism, is less likely to be influenced by age. In the EMAS study, the prevalence of men with primary hypogonadism increased significantly with age but not among men with low T and normal LH levels – men likely to have AOH (Tajar et al., 2010).
Among healthy aging men, hypothalamic-pituitary-gonadal function may be maintained (i.e., Nieschlag et al., 1982; Yeap et al., 2009; Sartorius et al., 2012). In a broader population of men, however, beginning at 20-30 years of age T levels decline by 0.3% to 1.4% per year (Wu et al., 2008). It is believed that declining T levels are partly the result of primary testis failure – the Leydig cells become less responsive to exogenous gonadotropin stimulation (Rubens et al., 1974) and the number of Leydig cells declines (Neaves et al., 1984).
The relationship between secondary hypogonadism and aging is complex. Production of GnRH decreases with age and GnRH/LH pulse amplitude diminishes (Araujo et al., 2011; Takahashi et al., 2005). In addition, androgen negative feedback suppression of LH secretion may be increased (Winters & Atkinson, 1997). Sex hormone binding globulin (SHBG) levels tend to rise in older men, causing free T levels to decline (Feldman et al., 2002). T levels are higher in the morning than in the evening and there is a dampening of this diurnal rhythm as men grow older (Zumoff et al., 1982).
Section 2: AOH and Common Comorbidities
AOH more often occurs in men who have chronic disease states that are more common as men age, making it difficult to separate the influence of comorbidities from the influence of aging. High BMI, central adiposity, and the metabolic syndrome are associated with low serum total T and low free T levels (Wang et al., 2011; Allan & McLachlan, 2010; MacDonald et al., 2010; Brand et al., 2011; Laaksonen et al., 2004, 2005). Low total and free T levels are associated with an increased risk of developing metabolic syndrome, independent of age and obesity (Wang et al., 2011; Allan & McLachlan, 2010; MacDonald et al., 2010; Brand et al., 2011). In the EMAS study, BMI was significantly associated with risk for secondary hypogonadism and the risk for secondary hypogonadism increased as a man’s number of comorbidities increased (Tajar et al., 2010).
Section 3: Clinical Signs and Symptoms of AOH
AOH is often overlooked because hypogonadal men ignore their symptoms (Dandona & Rosenberg, 2010). T influences all the steps of the male sexual response; sexual dysfunctions are a prominent symptom of AOH and are often the presenting symptom. These symptoms may include: hypoactive sexual desire (HSD), reduced nocturnal and morning erections, reduced sex-induced erections, delayed ejaculation and reduced semen volume (Buvat et al., 2013; Mulligan et al., 2006). The Endocrine Society and the American Association of Clinical Endocrinologists (AACE) suggest that physicians should measure the T levels of men with any of the symptoms and signs in Table 1.
Table 1: Conditions in which serum T measurement is suggested
(adapted from Bhasin et al., 2010)
Osteoporosis, low trauma fracture
Type 2 diabetes
Glucocorticoids, ketoconazole, opioid or other medications that affect T metabolism or production
Moderate to severe COPD
Sellar mass, radiation to the sellar region, or other diseases of the sellar region
End-stage renal disease, maintenance hemodialysis
HIV-associated weight loss
Section 4: Diagnosis and Monitoring
Men presenting with possible signs and symptoms of AOH must be systematically evaluated, accurately diagnosed, carefully counseled regarding the risks and benefits of treatment, and followed regularly if T replacement is initiated. The process recommended by the panel is summarized in Figures 2 and 3.
Risks and Safety of T. There are two challenges to understanding the risks of T replacement in appropriately selected men. The first challenge is the lack of definitive evidence derived from properly-designed prospective studies. The second challenge is the existence of mixed evidence that is not definitive from the literature that is available. In the absence of definitive evidence regarding risks, patients must be monitored regularly for adverse events.
Cardiovascular risks. Definitive evidence regarding the short- and long-term cardiovascular risks of T replacement is not yet available because the published prospective trials were not designed or powered to examine cardiovascular endpoints. The available trials and meta-analyses report mixed findings, with some finding no risks associated with T replacement and others reporting risks associated with T replacement. The need for definitive trials that can yield unambiguous findings is underscored by several recent publications using retrospective data that report possible risks of T replacement (i.e., Layton et al., 2015; Finkle et al., 2014; Vigen et al., 2013). The clinical utility of these data is unclear because of the inherent limitations of these studies (e.g., lack of assessment of whether men met criteria for T replacement, failure to compare event rates to those in non-T-using men, and statistical limitations). Therefore, it is critically important that men administered T be monitored regularly.
Prostate cancer risks. No appropriately designed and powered study has been conducted to assess prostate cancer-related risks of T replacement. The available evidence has yielded mixed findings although most studies have found no risk associated with T replacement (e.g., Hsing et al., 2001; EHPCCG, 2008; Calof et al., 2005). Given the absence of definitive evidence, men administered T should be monitored regularly.
Erythrocytosis. During TRT, levels of hemoglobin (Hb) and hematocrit (Hct) rise for the first 5-6 months, then tend to plateau (Swerdloff & Wang, 2003; Wang et al., 2004). Injectable T formulations are associated with the greatest treatment-induced increases in Hb and Hct (Dobs et al., 1999; Rhoden & Morgentaler, 2004; Vorkas et al., 2012; Jick & Hagberg 2013). Although it has been hypothesized that enhanced blood viscosity poses a threat for ischemic sequela, the direct relationship between TRT-induced erythrocytosis and subsequent risk for cardiovascular (CV) events has not been demonstrated through prospective randomized controlled trials (Schreijer et al., 2010; Braekkan et al., 2010; Vaya & Suescun 2013; De Stef et al., 2008; Glueck et al. 2014). Therefore, in the absence of sufficient information regarding risk, men administered T should be monitored regularly.
Benign Prostatic Hypertrophy (BPH)/Lower Urinary Tract Symptoms (LUTS). The preponderance of evidence indicates that T replacement has no effect on BPH and LUTS symptoms or improves symptoms (Amano et al., 2010; Francomano et al., 2014; Haider et al., 2009; Kalinchenko et al., 2008; Karazindiyanogly & Cayan, 2008; Pearl et al., 2013; Shigehara et al., 2011).
Section 5: Conclusion
AOH is a diagnosable clinical syndrome in which men experience signs and symptoms associated with low T levels and low or normal gonadotropin levels. Its etiology appears to include failure at the testicular and hypothalamic-pituitary levels, making it distinct from classical primary and secondary hypogonadism. The AOH presentation is more common among men with prevalent comorbidities such as obesity, metabolic syndrome, and diabetes. AOH is a more accurate diagnosis for the group of adult men most frequently diagnosed with hypogonadism. Men with AOH who are candidates for treatment with T should be counseled regarding the risks and benefits of treatment. Men who are treated with T should be monitored regularly given that definitive evidence regarding potential short-term and long-term risks of T is not yet available.
Acknowledgements and Disclosures
The SMSNA is a not-for-profit society established in 1994 to promote, encourage and support the highest standards of practice, research, education and ethics in the study of the anatomy, physiology, pathophysiology, diagnosis and treatment of human sexual function and dysfunction. The SMSNA strives to support the free exchange and discussion of new ideas, thoughts and concepts in sexual medicine.
The colloquium was funded by the SMSNA Foundation through an unrestricted grant from Repros Therapeutics, Inc. SMSNA required complete independence from industry during the development of this document. No industry representatives were present in the closed meeting, there was no industry participation in the evidence selection, discussion, or creation of this document, and there was no attempt by industry to influence its content.
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Dear Medical Director,
Many scientific studies document that sexual health is an integral part of good overall health and that sexual dysfunction compromises overall health and life satisfaction. The importance of sexual health in enhancing quality of life is an unchallenged and intuitive concept to men and women everywhere.
The Sexual Medicine Society of North America (SMSNA) is North America’s leading professional society, which is concerned with the medical aspects of sexual health and sexual dysfunction. Among the patients for whom our members care, the sexual side effects of treatment for benign enlargement of the prostate gland are a common problem. Benign enlargement of the prostate gland (also called benign prostatic hyperplasia or BPH) is a condition which affects most older men. Until recently, virtually all treatments for this common condition have been associated with risks of erectile dysfunction and/or ejaculatory dysfunction. Pharmacologic therapy for BPH provides modest improvement in urinary function but up to 30% of patients discontinue treatment because of insufficient improvement in urinary symptoms and/or bothersome side effects, including sexual dysfunction. Surgical therapy for BPH provides better levels of improvement in urinary function but also higher levels of sexual dysfunction. Studies on surgical therapy for BPH show that 3 to 14% of men suffer from erectile dysfunction and 30 to 80% suffer from ejaculatory dysfunction after treatment.
A new method for treatment of BPH, the cystourethroscopic insertion of permanent adjustable transprostatic implants (also known as the Urolift® prostatic urethral lift procedure), has been approved by the FDA. This new procedure has the key advantage of avoiding the risks of erectile and ejaculatory dysfunction while still providing excellent improvement in urinary function. In two key publications,1,2 the incidence of erectile and ejaculatory dysfunction after adjustable transprostatic implants was zero. The absence of sexual side effects of this therapy makes adjustable transprostatic implants a very attractive option for the treatment of BPH in all sexually active men. Some urologists believe it is the treatment of choice for sexually active men with BPH.
It has come to the attention of the SMSNA that your organization considers the Urolift® prostatic urethral lift procedure to be investigational and/or experimental in the treatment of BPH, thereby making this procedure ineligible for reimbursement. It is difficult for us to understand how an FDA approved procedure could be considered investigational or experimental. The SMSNA does not consider this FDA-approved procedure to be investigational or experimental. We believe that the Urolift® prostatic procedure is a standard option for the treatment of BPH and that it should be recognized as an appropriate therapeutic tool, which is being used by many urologists. We request that you reconsider your position on this procedure, which has excellent clinical results and which has the distinct advantage compared to other treatments for BPH of preserving normal sexual function.
|Lawrence S. Hakim
|Ira D. Sharlip
Legislative Affairs Committee Chair
- Woo HH, et.al. Preservation of sexual function with the prostatic urethral lift: a novel treatment for lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Sex Med 2012;9:568-575
- Roehrborn CG, et. al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol 2013;190:2161-2167
As a professional society dedicated to the effective and safe treatment of individuals with sexual dysfunction and men’s health overall, the Sexual Medicine Society of North America is aware of recent concerns regarding cardiovascular risks associated with the use of testosterone therapy. This concern stems from two journal articles, one published in November 2013 in the Journal of the American Medical Association (1), and the other published in January 2014 in the journal, Plos One (2). Neither of these reports was a planned experimental study with control groups and defined goals. Instead these were retrospective analyses of data collected for other reasons. These types of analyses are prone to bias and error, and results are often irreproducible (3). For this reason, this type of study is generally not used for medical decision-making, although in some cases these may prompt further investigation with an experimental study.
Review of both studies (click here for detailed analysis of these studies) reveals major flaws that render questionable the assertion that testosterone therapy increased cardiovascular (CV) risks. The suggestion of increased cardiovascular risk with these recent reports is contradicted by a large body of literature that strongly indicates CV risks in association with low testosterone levels, and beneficial effects of T therapy in improving risk factors for CV disease (4-7). Although an objective scientific approach must openly consider all new evidence, the SMSNA does not find these new reports to provide credible evidence of increased CV risk with T therapy.
Testosterone deficiency (also called hypogonadism) is a medical condition recognized for over a century, associated with symptoms that include reduced sexual desire, erectile dysfunction, fatigue, depressed mood, reduced muscle mass, and increased fat. Research has shown that T deficiency is also associated with a number of significant health issues, such as diabetes, obesity, the metabolic syndrome, and bone fractures (6). Several longitudinal population-based studies have demonstrated reduced longevity in men with low T levels (8-11). Treatment of T deficiency improves symptoms as well as several indicators of general health. Testosterone therapy is only indicated in men with characteristic symptoms or signs as well as documented low testosterone levels.
Like all treatments, T therapy has risks (12). The most common are erythrocytosis (increased production of red blood cells), acne, gynecomastia (breast enlargement), and fluid retention. The historical concern that T therapy promotes prostate cancer appears to be unfounded (13). The current evidence does not support the assertion that T therapy increases the risk of heart attacks, stroke, or other cardiovascular risks.
There is no reason to change the current management of men with testosterone deficiency on the basis of these recent articles. Men currently being treated for testosterone deficiency with testosterone therapy and experiencing benefits may continue treatment. Men diagnosed with testosterone deficiency should consider treatment with testosterone therapy after full discussion with their healthcare provider. Testosterone therapy provides significant benefits for men with sexual symptoms, and also for a variety of non-sexual symptoms. Like all medical treatments, testosterone therapy is associated with risks, and these should be discussed with one’s healthcare provider. Weighing the entirety of available medical research, there is no compelling evidence that testosterone therapy increases cardiovascular risks.
- Vigen R, O'Donnell CI, Barón AE, Grunwald GK, Maddox TM, Bradley SM, Barqawi A, Woning G, Wierman ME, Plomondon ME, Rumsfeld JS, Ho PM. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA. 2013;310:1829-1836.
- Finkle WD, Greenland S, Ridgeway GK, Adams JL, Frasco MA, Cook MB, Fraumeni Jr JF, Hoover RN. Increasing Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e85805. Doi: 10.1371/journal.pone.0085805
- Ioannidis, J. P. A. Contradicted and initially stronger effects in highly cited clinical research. Journal of the American Medical Association, 2005; 294, 218–228.
- Oskui PM, French WJ, Herring MJ, Mayeda GS, Burstein S, Kloner RA. Testosterone and the cardiovascular system: a comprehensive review of the clinical literature. J Am Heart Assoc. 2013 Nov 15;2(6):e000272
- Carson CC and Rosano G. Exogenous testosterone, cardiovascular events, and cardiovascular risk factors in elderly men: A review of trial data. J Sex Med 2012;9:54–67.
- Traish AM, Miner M, Zitzmann M, Morgentaler A. Testosterone deficiency. Am J Medicine, 124, 578-587, 2011.
- Aversa A, Bruzziches R, Francomano D, Rosano G, Isidori AM, Lenzi A, and Spera G. Effects of testosterone undecanoate on cardiovascular risk factors and atherosclerosis in middleaged men with late onset hypogonadism and metabolic syndrome: Results from a 24-month, randomized, double-blind, placebo-controlled study. J Sex Med 2010;7:3495–3503.
- Shores MM, Matsumoto AM, Sloan KL, Kivlahan DR. Low serum testosterone and mortality in male veterans. Arch Intern Med. 2006;166:1660–1665.
- Laughlin GA, Barrett-Connor E, Bergstrom J. Low serum testosterone and mortality in older men. J Clin Endocrinol Metab. 2008;93:68–75.
- Khaw KT, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Day N. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007;116:2694–2701.
- Haring R, Volzke H, Steveling A, Krebs A, Felix SB, Schofl C, Dorr M, Nauck M, Wallaschofski H. Low serum testosterone levels are associated with increased risk of mortality in a population-based cohort of men aged 20-79. Eur Heart J. 2010;31:1494–1501.
- Rhoden EL, Morgentaler A: Risks of testosterone-replacement therapy and recommendations for monitoring. N Engl J Med 350:482-92, 2004.
- Khera M, Crawford D, Morales A, Salonia A, Morgentaler A. A New Era of Testosterone and Prostate Cancer: From Physiology to Clinical Implications. Eur Urol. Epub 2013 Aug 16.
The statement below is based on a meeting convened in November 2011 by the Sexual Medicine Society of North America. The meeting consisted of a panel of internationally recognized experts in men's health, sexual medicine, endocrinology and prostate disease. The participants were charged with reviewing the medical literature as it stands at this time on the link between 5-alpha reductase inhibitors and persistent sexual side effects.
Five alpha-reductase inhibitors, a class of medication used to treat the symptoms of certain prostate conditions as well as male-pattern hair loss, are known to be associated with undesired sexual symptoms during treatment. Some of these symptoms may last for many years after stopping these medications. The Sexual Medicine Society of North America (SMSNA) recognizes that an association exists between these drugs and persistent undesirable symptoms after termination of treatment and that men with these symptoms are suffering. However, at this time, human scientific evidence does not allow us to define the prevalence or the cause of these symptoms. The medical literature is limited, and as such, it is currently impossible to definitively link, as cause and effect, these medications to the long-lasting symptoms these men experience. Future research is required to differentiate whether such symptoms are an association with or are the result of the use of these medications. SMSNA are committed to developing a better understanding of this problem, to defining which research avenues may be of most benefit and to developing clinical care pathways for such patients.
The Sexual Medicine Society of North America (SMSNA), a specialty society of the American Urological Association, supports in general the recent nationwide initiative to reduce peri-operative infections by the use of clippers rather than razors for preoperative hair removal. However, the delicate, irregular, and elastic skin of the male genitalia is ill-suited for clippers, which tend to produce multiple skin breaks, in contrast with razors, which have been used with good success for decades. In the absence of any evidence to the contrary, the SMSNA recommends that surgeons be permitted their choice of razors or clippers for preoperative preparation of the male genitalia.
Certain states have recently denied Medicaid therapy for erectile dysfunction to men who have been convicted of sexual offenses. The Sexual Medicine Society of North America, Inc. (SMS) acknowledges governments' need to protect its citizens from sexual predators. Denial of Medicaid benefits for erectile dysfunction is appropriate in the case of sexual predators.
SMS believes it is unwise and illogical to deny effective treatment of erectile dysfunction to all Medicaid beneficiaries.
Erectile dysfunction often results from certain serious organic diseases, including heart disease, high blood pressure, diabetes and high cholesterol. Current medical and surgical treatments of erectile dysfunction are safe and highly effective and can restore an essential bodily function.
Cigarette smoking is a risk factor for erectile dysfunction. Men who smoke have a greater chance of developing erectile dysfunction than men who do not smoke.
Diagnostic studies used to evaluate the pathophysiology of impotence should be individualized for each patient.
A generic or standard list of diagnostic tests for all patients is not an appropriate practice.
Studies used for the diagnostic evaluation of impotence should be limited in general to the tests which are needed to identify the treatment options available to each patient, taking into account each patient's unique clinical status and treatment preferences.
The patient who wishes to identify the cause or causes of his erectile dysfunction as organic and/or psychogenic, nocturnal penile tumescence and rigidity (NPTR) monitoring, vascular and other testing are useful, but the patient must be provided information permitting an informed decision to seek testing which is not essential to the selection of treatment options.NPTR monitoring and extensive vascular testing are not indicated for the diagnostic evaluation of every impotent patient.
Ethical medical practice requires that diagnostic, therapeutic and other decisions must be made solely for the benefit of the patient and must be made without regard for the benefit of the health care provider.
The Society for the Study of Impotence has found no peer-reviewed, objective or independently- monitored studies, or other data, which prove the safety or efficacy of penile lengthening and girth enhancement surgery.
The Society believes that, in men who do not have congenital anatomical anomalies of the penis, the safety and efficacy of penile lengthening and girth enhancement surgery have not been established.
Therefore, penile lengthening and girth enhancement surgery can only be regarded as experimental surgery.
The Society is aware of complications and adverse outcomes which should be clearly disclosed to patients considering such surgery.
The Society believes that those government agencies charged with the regulation of medical practice and the enforcement of laws prohibiting false or unsubstantiated advertising claims should give careful attention to claims made with regard to these surgical procedures.
Testosterone supplementation is indicated for men who have signs and symptoms of hypogonadism accompanied by subnormal serum testosterone measurements. Testosterone supplementation can provide important health benefits to these hypogonadal men. Testosterone supplementation should be administered only under competent and careful medical surveillance in order to identify early signs of possible adverse effects. Although the benefits and risks of long-term testosterone supplementation have not yet been definitively established, the weight of current evidence does not suggest an increased risk of heart disease or prostate cancer with long-term use of testosterone. Testosterone is not medically indicated in men who do not have hypogonadism.
Hypogonadism is a clinical and biochemical syndrome associated with a deficiency in serum testosterone. Manifestations include diminished sexual interest and performance, depression, lack of energy and vitality, anemia, decreased bone density and muscle mass. When this symptom complex occurs in the adult male, it is known as late onset hypogonadism, androgen deficiency in the aging male (ADAM) or andropause.
The diagnosis of hypogonadism is made by correlating the clinical signs and symptoms with blood tests documenting low levels of serum testosterone.
A. Symptoms. The clinical picture includes diminished sexual desire and erectile quality, depressed mood, irritability, tiredness and fatigue. These manifestations need not all be present to identify the syndrome and the severity of one or more does not necessarily match the severity of the others. B. Physical examination. The physical examination is frequently unremarkable. Small or soft testicles may be present. Gynecomastia, truncal obesity, loss of muscle mass and manifestations of osteoporosis may also be associated with hypogonadism. C. Blood tests. The levels of serum testosterone, normally, are highest in the morning and may decline significantly throughout the day. Several blood assays to measure serum testosterone are available. Total testosterone is most commonly used but requires awareness that its values may not reflect the amount of metabolically active testosterone fractions. For this reason, measurement of bioavailable or free testosterone may more closely correlate with clinical symptoms. D. Other blood tests. Follicle stimulating hormone (FSH), luteinizing hormone (LH) and prolactin are frequently assayed to assist in determining the cause of hypogonadism (primary vs secondary).
Presently, injectable, oral and transdermal preparations of testosterone are available in North America. With the exception of testosterone undecanoate (currently unavailable in the United States), oral preparations carry a significant risk of liver toxicity. Injectable, transdermal and the oral undecanoate are all acceptable treatment options.
and risks A. Benefits. Benefits of testosterone supplementation include improvement in any or all of the following: sense of well being, sexual function (sexual interest and erection), energy, mood, cognition and body composition (muscle strength, bone mineral density, fat distribution and correction of anemia). B. Adverse effects. Adverse effects of testosterone supplementation include erythrocytosis, increased prostate volume, gynecomastia, edema, testicular atrophy and acne. C. Risks. Risks include exacerbation of a pre-existing (sub-clinical) cancer of the prostate. Worsening of sleep apnea is also a potential risk of testosterone administration.
and follow-up Careful, regular monitoring is recommended at 3-6 month intervals for the first year and at 6-12 month intervals thereafter. Physician’s evaluation should include an assessment of the clinical response, a digital rectal examination, blood tests for testosterone, hemoglobin, hematocrit, and prostate specific antigen (PSA). Lipid profile and liver function tests may also be considered.
February 11, 2003
(Submitted by the Androgen Supplement SubCommittee, a subcommittee of the SMS Health Policy Committee)
Alvaro Morales, M.D., Kingston, ONT
Chairman Culley Carson, M.D., Chapel Hill, NC
Wayne Hellstrom, M.D., New Orleans, LA
Larry Lipshultz, M.D., Houston, TX
Abe Morgentaler, M.D., Boston, MA
The SMSNA strongly supports the development of novel erectogenic therapies, given that many men with ED either fail currently available treatments or find them unpalatable. The society, however, recognizes the need for adequately powered, multicenter, randomized, sham/placebo-controlled trials in well-characterized patient populations to ensure that efficacy and safety are demonstrated for any novel ED therapy. The society agrees with the regulatory agency pathway of Phase I, II and III studies to achieve such a goal. Without FDA approval, the use of any novel therapy is considered off-label. The emergence of low intensity shock wave therapy (LiSWT), intracavernous stem cell therapy (SCT), intracavernous platelet rich plasma (PRP) therapy (and other agents such as amniotic fluid) represent a new frontier of investigative restorative therapies for ED treatment. In contrast to existing pharmacologic therapies that treat symptoms, therapies such as LiSWT, SCT, PRP represent potentially restorative modalities based on the concept that they might regenerate erectile tissues.
There exists robust basic science evidence in a variety of animal models (aged, diabetic, cavernous nerve injury) supporting the ability of LiSWT and SCT to improve erectile function. However, to date, there is an absence of robust clinical trial data supporting their efficacy and long-term safety in humans. Furthermore, the precise treatment parameters (energy settings, dosing, frequency of use, and duration of therapy among others) and cell source allowing optimization of these evolving therapies remain as yet, undefined. There exists only a small number of animal studies in a single model (cavernous nerve injury) establishing PRP as a potential erectogenic therapy. At this time, there are no human studies evaluating PRP as an erectogenic therapy.
Although several plausible and scientifically sound mechanisms of action have been proposed to explain how restorative therapies might improve erectile function, rigorous experimental data conclusively validating these mechanisms is currently lacking. This is in part because, unlike conventional pharmacologic therapies which generally have a primary, well-defined target, the mechanism of action of restorative therapies is likely to be complex involving a number of pathways inherent to the regenerative potential of the host. The SMSNA both advocates for and supports the application of high quality research, both pre-clinical and clinical, aimed at better understanding the mechanisms involved, the magnitude and durability of benefit and the long-term safety of restorative therapies.
Thus, given the current lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, SMSNA believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval. Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks. Finally, the SMSNA advocates that patients involved in these clinical trials should not incur more than basic research costs for their participation.
To view the document click here.
The SMSNA Position on Restorative Therapies for ED was also referenced in the following article in Healthline.