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Stakeholder Perspectives in Men's Health August 2014
John A Welz, MPH

As the US healthcare system continues to evolve, physicians in every state and specialty are attempting to comply with new rules, expectations, and costs, and must adapt to meet new healthcare demands. These changes are being driven by a combination of clinical and economic factors, including therapeutic innovation, improved diagnostic and surgical techniques, and perhaps most prominently, a policy environment where purchasers of healthcare are increasingly focused on accountability, quality, and value.

For clinicians who manage conditions such as erectile dysfunction (ED), low testosterone, and Peyronie’s Disease (PD), these sweeping healthcare policy changes coincide with remarkable technological and pharmaceutical innovations, which have significantly improved outcomes for men with urologic conditions. Together, however, the combination of comprehensive healthcare reforms and fast-paced clinical advances has resulted in a challenging environment for urologists and other clinicians who treat these conditions. In order to continue to provide state-of-the-art, quality-driven, and cost-effective care for their patients, these specialists must reconsider both clinical and economic aspects of their practices.

Business Challenges for Today’s Urology Practice
In order to thrive in today’s healthcare environment, today’s urology practices must innovate. Many practices have consolidated to remain competitive, while others have sought to expand their coverage area and attract more new patients. Some of the approaches that have been implemented to mitigate risk, improve financial health, and maximize patient retention for urology practices include:

  • Increasing patient volume (workload): more patients per day, more surgeries per week, the addition of evening hours
  • Adding urology staff or consolidating private practices to broaden the catchment area
  • Performing new procedures or prescribing newly available therapies
  • Maximizing referrals from primary care physicians
  • Partnering with local or regional hospital networks
  • Expanding the service line, including drug infusion services, pathology, diagnostic imaging, radiation, surgery, and/or clinical research.

Despite past communication challenges with payers (typically regarding contracting, prior authorization requirements, and step-edit restrictions), private urology practices now recognize that their financial objectives are increasingly aligned with the payer community. At the same time, payers now appreciate that supporting independent physician practices (relative to hospital-based care settings) has meaningful consequences in terms of the cost, and perhaps also the quality, of patient care.

In a recent engagement of urologists and urology practice administrators, participants noted the positive consequences of including payers’ medical directors, whom one dubbed “the voice of [clinical] reason,” in contract negotiation meetings. In addition to more fair contracts, such meetings were said to lay the groundwork for constructive future collaborations with the payer. Panelists believed that quantitative data regarding differences in patient satisfaction, as well as the cost of care, between office- and hospital-based sites of care will enhance the likelihood that these productive payer–practitioner relationships will continue.1

Central Role of the Urologist in Treating Men’s Health Issues
One can argue that there are disparities between men’s and women’s healthcare. The gynecologic and obstretric specialties were developed specifically to address women’s health needs, and men do not have a corresponding specialty devoted to gender-specific health issues. Men have higher rates of physical inactivity, poor nutrition, and excessive alcohol consumption than women. In addition, studies have shown that men are more resistant to engaging with the healthcare system or participating in preventive health practices than women. Ongoing research has revealed an association between metabolic dysfunction and urologic disorders such as lower urinary tract symptoms, low testosterone, and ED.2

Timely treatment of disorders such as ED and low testosterone may have important health implications for men who are affected. More than 50% of premature male deaths in the United States are a result of chronic but preventable medical conditions. ED and low testosterone are often associated with comorbidities of a chronic nature, but these urologic disorders can also precede a major medical event, such as a heart attack or stroke, by several years. This association may well offer an opportunity for early detection and prevention of life-threatening eventualities.3

To address these issues, the urology community has begun to take a more active leadership role in men’s health. In 2009, the American Urological Association created the Committee on Male Health. The Committee was charged with developing a comprehensive approach to address issues of men’s health, including education, community outreach, research, integration with other specialties, and support of local and national men’s health initiatives.2

Ultimately, the urology community is best positioned to lead the consolidation of men’s health concerns and the means to address those concerns. It is possible that, through their role in providing specialized care for a wide range of men’s health needs, the urologist may emerge as the authority and coordinator of care for the majority of men as they navigate their way through the healthcare system.2

Peyronie’s Disease: An Underrecognized Disorder
PD is a good example of a condition that calls for the expertise of a specialist in men’s healthcare. For a man with PD, healthcare needs can range from medication and physical therapy to a variety of surgical interventions to psychological and psychosocial support. The urologist with heightened awareness of the ramifications of this condition can take a proactive role in treating these patients and coordinating their care and their access to the variety of services and support needed to treat the whole man.

PD is one of several gender-specific disorders experienced by men that place a substantial physical and psychological burden on sufferers. PD is a wound-healing disorder of the penis characterized by the formation of fibrous, inelastic plaques located in the tunica albuginea, the fibrous sheath surrounding the corpora cavernosa of the penis. The formation of these plaques results in penile deformities during erection, including curvature, shortening, narrowing, and bending (also known as the hinge effect). The disease does not generally resolve without treatment.4-6

Prevalence estimates for PD vary widely, and it is believed to be underreported for a number of reasons. A web-based survey of a large (N = 11,420) probability-based panel of research subjects representative of the full US population estimated the prevalence of PD to range from 0.5% (the percentage of surveyed subjects with PD diagnosis) to 13% (percentage with diagnosis, treatment, or penile symptoms of PD).7

In another claims-based market research analysis of men with PD in the United States, an estimated 118,182 men with PD (6.4% of all men with the condition) sought treatment for their deformity. An estimated one-third of these men (n = 38,646) had moderate to severe curvature deformity of at least 30°.8

The Burden of Peyronie’s Disease
Men with PD experience significant anxiety and psychological distress, and related effects may include depression, emotional distress, reduced quality of life because of PD-related pain and discomfort, and diminished self-esteem. These factors have been reported to negatively impact sexual relationships, restrict intimacy, and cause social isolation and stigmatization.4

Psychosocial function and sexual function are important issues for men with PD. In a series of interviews, patients with PD indicated that they experienced significant issues with PD-related pain and discomfort, physical appearance and self-image, sexual performance and function, and social stigmatization and isolation. In this analysis, the major themes and patterns of response were consistent across the groups of men with PD.9

Sustained depression is relatively common among men with PD. In a survey of 92 men with diagnosed PD, 48% were classified as clinically depressed based on their scores on the Center for Epidemiological Studies Depression Scale. Furthermore, the percentage of these patients with depression did not change significantly with time since diagnosis, suggesting lack of mental adjustment to the diagnosis of PD. Given the high initial rate of depression, the authors concluded that all men with PD should be screened for mental illness.10

Etiology, Pathophysiology, and Natural History of Peyronie’s Disease
The etiology of PD has not been well characterized. A leading hypothesis postulates that trauma is the most likely trigger for PD, activating an abnormal response to local injury in a man who has a genetic predisposition to abnormal scar formation and healing. Specifically, repeated mechanical stress and microvascular trauma of the penis resulting from excessive bending or single blunt trauma to the erect penis causes bleeding into the subtunical spaces and subsequent tissue damage.4,6,11

In these individuals, collagen synthesis is thought to increase abnormally, and resulting plaque formations interfere with the elasticity of the tunica albuginea. Although the specific mechanisms have not been elucidated, it is thought that changes in elastin fibers and collagen types can contribute to the formation of penile deformities. Fibrin deposits in the injured tissue may initiate an inflammatory wound healing response with resultant recruitment of macrophages, neutrophils, and fibroblasts.4,6,11

First symptoms of PD vary. In about half (52%) of men with the disorder, the first noticeable symptom is a penile deformity. The first presenting symptom is penile pain or a lump in about 40% and 21% of men, respectively.12

The natural history of PD involves acute and chronic phases. The acute phase, which generally lasts 12 to 18 months, is characterized by progression in plaque size and progression in curvature deformity, often with pain at the site of the plaque and painful erections that are caused by inflammation. Plaque size and curvature deformity stabilize during the chronic phase and inflammation and pain are not characteristic of this phase of the disease.5,6,13

Treatment of Peyronie’s Disease
Effective treatment options for PD are limited. In treating PD, a number of nonsurgical interventions are used in clinical practice, including oral and topical treatments (vitamin E, tamoxifen, pentoxifylline, potassium para-aminobenzoate, colchicine) and intralesional injections (corticosteroids, interferons, verapamil). Although the aforementioned treatments may result in some improvement in PD signs, such as penile curvature deformities and psychosocial symptoms, none have been approved by the US Food and Drug Administration (FDA) as safe and effective for the treatment of PD. Furthermore, most historically available, minimally invasive treatments have little in the way of controlled data demonstrating efficacy.4,5,7,14

Some men with symptomatic PD may opt for surgery. International Society for Sexual Medicine guidelines indicate that to be eligible for surgery, patients should have stable disease and a compromised ability or an inability to engage in coitus, have extensive plaque calcification, or desire a rapid and reliable result. Surgical procedures include tunica albuginea plication, plaque incision or partial excision of the plaque with grafting, and implantation of a penile prosthesis with straightening maneuvers.5

However, surgery may be reserved for severe cases of PD because of serious complications that include penile shortening, ED, neurovascular injury, infection, and decreased sexual sensation.5,14,15

References

  1. Raedler LA, Welz JA. Business challenges and opportunities for today’s urology practices. Urol Pract Manag. 2013;2:7-8.
  2. Elterman DS, Kaplan SA, Pelman RS, Goldenberg SL. How ‘male health’ fits into the field of urology. Nat Rev Urol. 2013;10:606-612.
  3. Grauer NA. Treating the whole man. Dome. 2013;64:7.
  4. Levine LA. The clinical and psychosocial impact of Peyronie’s disease. Am J Manag Care. 2013;19:S55-S61.
  5. Ralph D, Gonzalez-Cavadid N, Mirone V, et al. The management of Peyronie’s disease: evidence-based 2010 guidelines. J Sex Med. 2010;7:2359-2374.
  6. Miner MM, Seftel AD. Peyronie’s disease: epidemiology, diagnosis, and management. Curr Med Res Opin. 2014;30:113-120.
  7. DiBenedetti DB, Nguyen D, Zografos L, Ziemiecki R, Zhou X. A population-based study of Peyronie’s disease: prevalence and treatment patterns in the United States. Adv Urol. 2011;2011:282503.
  8. Data on file. Auxilium Pharmaceuticals, Inc.
  9. Rosen R, Catania J, Lue T, et al. Impact of Peyronie’s disease on sexual and psychosocial functioning: qualitative findings in patients and controls. J Sex Med. 2008;5:1977-1984.
  10. Nelson CJ, Diblasio C, Kendirci M, Hellstrom W, Guhring P, Mulhall JP. The chronology of depression and distress in men with Peyronie’s disease. J Sex Med. 2008;5:1985-1990.
  11. Moreland RB, Nehra A. Pathophysiology of Peyronie’s disease. Int J Impot Res. 2002; 14:406-410.
  12. Pryor JP, Ralph DJ. Clinical presentations of Peyronie’s disease. Int J Impot Res. 2002; 14:414-417.
  13. Kadioglu A, Küçükdurmaz F, Sanli O. Current status of the surgical management of Peyronie’s disease. Nat Rev Urol. 2011;8:95-106.
  14. Gelbard M, Goldstein I, Hellstrom WJG, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of Peyronie’s disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013;190: 199-207.
  15. Wespes E, Hatzimouratidis K, Eardley I, et al; European Association of Urology. Guidelines on penile curvature. European Association of Urology website. www.uroweb.org/gls/pdf/16%20Penile%20Curvature_LR.pdf. Published February 2012. Accessed May 9, 2014.
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