Superior Cost Effectiveness of Penile Plication vs Intralesional Collagenase Injection for Treatment of Peyronie's Disease Deformities.

INTRODUCTION: In 2013 injection of collagenase clostridium histolyticum became the first nonsurgical FDA (Food and Drug Administration) approved treatment for Peyronie's disease. We evaluated the cost effectiveness of collagenase injection compared to penile plication. METHODS: A decision tree model using TreeAge Pro Healthcare (TreeAge Software, Inc., Williamstown, Massachusetts) was developed for cost analysis comparing collagenase clostridium histolyticum and penile plication. Treatment success was defined as penile curvature of 30 degrees or less. Data from IMPRESS (Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) I and II were used to calculate the probability of success, and stratified by severity of disease (moderate defined as 30 to 60 degrees and severe as 61 to 90 degrees). We assumed that 50% of injection failures proceeded to secondary plication. Material costs of medications, office visits, and facility and surgical fees, and predicted costs of complications were obtained from our billing department using real-world patient data. For penile plication 90% success was assumed based on published series. All failed plications were assumed to undergo repeat plication. RESULTS: The calculated probability of treatment success after injection was 49.5% for moderate curvature (30 to 60 degrees) and 12% for severe curvature (61 to 90 degrees). Per patient plication cost was $3,039, while injection pathway was $25,856 for moderate disease and $26,375 for severe disease. One-way sensitivity analyses revealed cost equivalence at $2,558 for injection. No increase in efficacy of collagenase injection accomplished cost equivalence at current pricing. CONCLUSIONS: Collagenase clostridium histolyticum treatment was at least 8 times more expensive than penile plication. Achieving cost equivalence would require a significant decrease in drug cost. Collagenase clostridium histolyticum appears to be most appropriate for men with moderate, as opposed to severe, penile deformities.

Priapism: pathogenesis, epidemiology, and management.

INTRODUCTION: Priapism describes a persistent erection arising from dysfunction of mechanisms regulating penile tumescence, rigidity, and flaccidity. A correct diagnosis of priapism is a matter of urgency requiring identification of underlying hemodynamics. AIMS: To define the types of priapism, address its pathogenesis and epidemiology, and develop an evidence-based guideline for effective management. METHODS: Six experts from four countries developed a consensus document on priapism; this document was presented for peer review and debate in a public forum and revisions were made based on recommendations of chairpersons to the International Consultation on Sexual Medicine. This report focuses on guidelines written over the past decade and reviews the priapism literature from 2003 to 2009. Although the literature is predominantly case series, recent reports have more detailed methodology including duration of priapism, etiology of priapism, and erectile function outcomes. MAIN OUTCOME MEASURES: Consensus recommendations were based on evidence-based literature, best medical practices, and bench research. RESULTS: Basic science supporting current concepts in the pathophysiology of priapism, and clinical research supporting the most effective treatment strategies are summarized in this review. CONCLUSIONS: Prompt diagnosis and appropriate management of priapism are necessary to spare patients ineffective interventions and maximize erectile function outcomes. Future research is needed to understand corporal smooth muscle pathology associated with genetic and acquired conditions resulting in ischemic priapism. Better understanding of molecular mechanisms involved in the pathogenesis of stuttering ischemic priapism will offer new avenues for medical intervention. Documenting erectile function outcomes based on duration of ischemic priapism, time to interventions, and types of interventions is needed to establish evidence-based guidance. In contrast, pathogenesis of nonischemic priapism is understood, and largely attributable to trauma. Better documentation of onset of high-flow priapism in relation to time of injury, and response to conservative management vs. angiogroaphic or surgical interventions is needed to establish evidence-based guidance.

Vardenafil rescue rates of sildenafil nonresponders: objective assessment of 327 patients with erectile dysfunction.

OBJECTIVES: To prospectively investigate whether vardenafil can effectively treat patients for whom sildenafil (100 mg) has failed. The introduction of two new oral phosphodiesterase type 5 inhibitors (tadalafil and vardenafil) raises the question of whether the new agents will permit us to treat sildenafil nonresponders with another oral agent. METHODS: Patients were seen at one institution during a 5-year period. A total of 327 patients complaining of sildenafil-refractory erectile dysfunction underwent intracavernous pharmacologic injection and color duplex Doppler ultrasonography. Subsequently 59 of these men tried vardenafil home dosing. RESULTS: Of the 327 men in whom sildenafil failed, 16% were younger than 50, 21% were 51 to 60, 34% were 61 to 70, and 28% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 154 (47%), mixed vascular insufficiency in 73 (22%), and cavernous venous occlusive disease in 57 (17%). Forty-three men (13%) had normal erectile responses to prostaglandin E1 (10 to 20 microg). Of the 59 men who tried vardenafil, 19% were younger than 50, 17% were 51 to 60, 40% were 61 to 70, and 23% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 28 (42%), mixed vascular insufficiency in 10 (19%), and cavernous venous occlusive disease in 15 (29%). Six men (8%) had normal erectile responses to prostaglandin E1. Only 7 (12%) of the 59 men reported that home vardenafil dosing resulted in successful intercourse. CONCLUSIONS: An appropriate diagnostic evaluation and subsequent treatment algorithm have yet to be established for those for whom phosphodiesterase type 5 inhibitors fail. We found that most sildenafil nonresponders had severe arterial insufficiency and were older, with 62% older than 60 years. Our preliminary experience suggests that only a small percentage (12%) of sildenafil nonresponders can be salvaged with vardenafil.