Insurance approval rates for collagenase clostridium histolyticum prior to discontinuation: a Canada-wide analysis.

Collagenase Clostridium histolyticum (CCh), the first approved non-surgical treatment for Peyronie's disease (PD), was withdrawn from the European, Canadian, and Asian markets due to poor demand and lack of government reimbursement options. We sought to assess insurance approval rates and usage of CCh across Canada to understand the factors that led to its withdrawal. Data on patients prescribed CCh for PD or Dupuytren's contracture was obtained through collaboration with BioScript Solutions to assess the association of variables with insurance approval and prescription filling. We identified 3297 insurance coverage applications for Xiaflex® from April 2018 to June 2020. Of all applications for PD, 92.9% applications were approved while 7.1% were rejected. Despite the withdrawal of CCh from Canadian markets, coverage application approval rates for 2018, 2019, and 2020 were 86.5%, 90.1%, and 89.1%, respectively. Of 2921 approved applications, 88.8% prescriptions were filled. For the 376 rejected applications, 66.4% of prescriptions were filled. Overall, 90% of the cost of Xiaflex® was covered in Canada among those with extended health benefits, with an out-of-pocket expense of $210.4. Insurance coverage requests for Xiaflex® were approved at a high rate in Canada with approved patients being very likely to proceed with therapy, despite interprovincial variation.

Canadian provider perspectives on Collagenase Clostridium histolyticum for the treatment of Peyronie's disease and the impact of its discontinuation.

Intralesional Collagenase Clostridium histolyticum (CCh) was the first non-surgical therapy approved for Peyronie's disease (PD). However, CCh's cost and poor market uptake has led to its discontinuation in Europe and Canada. In Canada, Xiaflex® is the trade name for CCh and it is produced by Paladin Labs Inc, an operating company of Endo International. The paper aims to better understand Canadian CCh providers' perspectives regarding its treatment efficacy and the potential impact of its discontinuation. All Xiaflex®-approved Canadian providers were asked to complete an anonymous 21-question survey using an online platform. Analysis consisted of descriptive statistics. Outcomes of interest included previous experience with CCh, protocols utilized, experience with insurance coverage, clinical and patient-reported outcomes, and provider perspectives on the discontinuation of CCh. Overall response rate was 48.3% (29/60). A total of 89% of respondents were male, 61% were in practice more than 10 years, 32% were in an academic practice, and 46% had completed an Andrology/Sexual Medicine fellowship. A total of 93% of respondents felt that CCh was superior to other intralesional therapies for PD. In all, 86% reported a patient satisfaction rate of at least 50%, and the majority (75%) saw a clinically meaningful response. Only 7% expressed difficulty obtaining insurance coverage, with many providers (71%) achieving an insurance approval rate between 75 and 100%. Only 54% of respondents reported that they would continue treating PD in light of CCh's discontinuation, and 96% felt that CCh's discontinuation represents a loss to Canadian patients. In light of CCh's discontinuation, most (79%) are now more likely to offer surgical treatment. In conclusion, most CCh providers found CCh to be effective and were dismayed by its discontinuation. The survey demonstrated that due to the withdrawal of CCh from Canada, physicians' abilities to offer effective medical therapy may become limited, with more providers offering surgical options for PD.

The Comparative Outcomes of Radical Prostatectomy versus Radiotherapy for Nonmetastatic Prostate Cancer: A Longitudinal, Population-Based Analysis.

PURPOSE: The comparative effectiveness of radical prostatectomy (RP) versus radiation therapy (RT) for prostate cancer remains a largely debated topic. Utilizing a provincial population-based linked data set from an equal-access, universal health care system, we sought to compare outcomes among patients treated with either radiation or prostatectomy for nonmetastatic prostate cancer. MATERIALS AND METHODS: We performed a retrospective cohort study by linking several administrative data sets to identify patients who were diagnosed with prostate cancer between 2004 and 2016 in Manitoba, Canada and who were subsequently treated with either RP or RT. Cox proportional hazard models with inverse probability of treatment weighting were used to compare rates of all-cause mortality, as well as prostate cancer specific mortality (PCSM) between patients who underwent RP vs RT. RESULTS: During the study period, 2,540 patients underwent RP and 1,895 underwent RT for prostate cancer. Unadjusted overall survival was higher for RP vs RT (5-year overall survival 95.52% for RP compared with 84.55% for RT, p <0.0001). In inverse probability of treatment weighting-adjusted Cox regression analysis, compared to patients in the RP groups, patients in the RT group had an increased rate of all-cause mortality (HR 1.93, 95% CI 1.65-2.26, p <0.0001), and PCSM (HR 3.98, 95% CI 2.89-5.49; p <0.0001). CONCLUSIONS: RT was associated with higher all-cause mortality and PCSM rates compared with RP. These findings highlight the importance of comparative effectiveness research to identify treatment disparities and warrant further investigation.

Prognostic significance of extent of venous tumor thrombus in patients with non-metastatic renal cell carcinoma: Results from a Canadian multi-institutional collaborative.

PURPOSE: The prognostic significance of level of venous tumor thrombus (VTT) extension in patients with non-metastatic renal cell carcinoma (RCC) has been controversial. The aim of this study was to examine the prognostic significance of VTT extent in patients who underwent surgery for non-metastatic RCC. MATERIALS AND METHODS: The Canadian Kidney Cancer information system database was used to identify patients who underwent surgery for non-metastatic RCC and VTT from January 2011 to December 2019. Association between VTT level and recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS) was examined. Univariable and multivariable analyses were performed to estimate predictors of survival. RESULTS: Out of 6,340 patients during the study period, 228 patients (3.6%) had VTT. VTT was level 0 in 84 (37%), level I to II in 112 (49%), and level III to IV in 33 (14%) patients as per the Mayo Clinic classification. Median age was 65.4 years (interquartile range [IQR] 57.6-72.2) and 169 (74.1%) were male. After a median follow-up of 21.2 months, VTT level did not significantly impact the RFS, CSS, or OS. For VTT level 0, I to II, and III to IV, there was no significant difference in estimated 5-year RFS (31%, 23%, and 30.5%; P > 0.05), CSS (70%, 69%, and 55%; P > 0.05) and OS (64%, 66%, and 50%; P > 0.05). Adjusting for known prognostic factors, thrombus level was not associated with risk of recurrence or death. CONCLUSION: In a large, multi-institutional cohort of patients undergoing surgery for non-metastatic RCC with tumor thrombus, thrombus extent was not independently associated with recurrence or death.

The impact of cannabis use on male sexual function: A 10-year, single-center experience.

INTRODUCTION: Despite increasing consumption rates in much of the world, the impact of cannabis use on various components of male sexual function remains poorly established. The purpose of this study was to further evaluate the relationship between cannabis use and reproductive and sexual function using a large patient cohort from a single academic andrology clinic. METHODS: This is a historical cohort study from a single academic center andrology clinic. Patients from 2008-2017 were included. Intake questionnaires provided baseline demographic information, as well as data regarding substance use and various sexual function parameters. Subjects were categorized as cannabis users or non-users. Cannabis users and non-users were compared using descriptive statistics and Chi-squared tests, and regression analyses were performed to test for association. RESULTS: A total of 7809 males were included in the study; 993 (12.7%) were cannabis users and 6816 (87.3%) were non-users. Cannabis users had a higher mean Sexual Health Inventory for Men (SHIM) score (21.9±4.4 vs. 21.2±4.8, p<0.001) and mean serum total testosterone (13.4±12.0 nmol/L vs. 12.6±11.8 nmol/L, p=0.04) than non-users, although they also had a higher rate of positive Androgen Deficiency in the Aging Male (ADAM) scores (52% vs. 46%, p<0.001). Cannabis users also reported higher sexual frequency compared to non-users (8.8 events/month vs. 7.8 events/month, p<0.05). On multivariate analysis, cannabis use was not associated with SHIM score or serum testosterone concentration. Cannabis use was associated with positive ADAM scores. CONCLUSIONS: Cannabis use was not associated with clinically significant deleterious effects on male sexual parameters in this cohort.

Patient Satisfaction With Telemedicine Appointments in an Academic Andrology-focused Urology Practice During the COVID-19 Pandemic.

OBJECTIVE: To evaluate patient satisfaction with telemedicine appointments as an alternative to in-person appointments at an Andrology-focused academic urology practice during the coronavirus disease 2019 pandemic. METHODS: Between March and June 2020, all appointments at the practice of a single Andrology-focused academic urologist were conducted by telephone. Consecutive patients were contacted by telephone following their appointment to complete a telephone questionnaire. Baseline demographic information was obtained, and perceptions regarding telephone appointments were assessed using a Likert scale. RESULTS: Ninety-six patients completed the telephone questionnaire. Median age was 48.5 years (interquartile range 37.3-62.8 years) with 55 of 96 (57.3%) of the appointments Andrology-focused. Mean distance of residence from the hospital was 8.4 km (interquartile range 4.7-25.2 km). Only 9 of 96 (9.3%) of the patients felt that the telephone format did not adequately address their needs. However, 26 of 96 (27.1%) of patients said they would prefer an in-person appointment. On multivariable analysis adjusting for age, gender, presenting complaint, type of appointment, education level, and employment status, no factors were associated with feeling that the telephone appointment adequately addressed needs or preference for an in-person appointment in the future. CONCLUSION: Patients were generally satisfied with telephone appointments as an alternative to in-person appointments during the coronavirus disease 2019 pandemic. Nonetheless, a substantial portion of patients said they would prefer in-person appointments in the future.

Impact of Time to Surgery and Surgical Delay on Oncologic Outcomes for Renal Cell Carcinoma.

PURPOSE: The time between radiographic identification of a renal tumor and surgery can be concerning for patients and clinicians due to fears of tumor progression while awaiting treatment. This study aimed to evaluate the association between surgical wait time and oncologic outcomes for patients with renal cell carcinoma. MATERIALS AND METHODS: The Canadian Kidney Cancer Information System is a multi-institutional prospective cohort initiated in January 2011. Patients with clinical stage T1b or greater renal cell carcinoma diagnosed between January 2011 and December 2019 were included in this analysis. Outcomes of interest were pathological up staging, cancer recurrence, cancer specific survival and overall survival. Time to recurrence and death were estimated using Kaplan-Meier estimates and associations were determined using Cox proportional hazards models. RESULTS: A total of 1,769 patients satisfied the study criteria. Median wait times were 54 days (IQR 29-86) for the overall cohort and 81 days (IQR 49-127) for cT1b tumors (1,166 patients), 45 days (IQR 27-71) for cT2 tumors (672 cases) and 35 days (IQR 18-61) for cT3/4 tumors (563). Adjusting for comorbidity, tumor size, grade, histological subtype, margin status and pathological stage, there was no association between prolonged wait time and cancer recurrence or death. CONCLUSIONS: In the context of current surgeon triaging practices surgical wait times up to 24 weeks were not associated with adverse oncologic outcomes after 2 years of followup.

Evaluation of Reported Fertility Preservation Counseling Before Chemotherapy Using the Quality Oncology Practice Initiative Survey.

Importance: The opportunity to discuss fertility preservation is essential for patients of reproductive age with newly diagnosed cancer before the initiation of treatment. Objective: To identify factors associated with fertility preservation counseling among patients of reproductive age before initiating chemotherapy. Design, Setting, and Participants: This cross-sectional study used data obtained from the American Society of Clinical Oncology (ASCO) Quality Oncology Practice Initiative, an oncologist-led quality assessment program that surveys approximately 400 oncology practices biannually, from January, 2015, to June, 2019. Main Outcomes and Measures: The primary outcome was whether reproductive risks were discussed before initiation of chemotherapy. Multivariate logistic regression was performed to identify factors associated with fertility preservation counseling, controlling for age, sex, race/ethnicity, cancer type, year of study, region, clinic type (academic vs private), annual clinic volume, and rates of insurance coverage. Results: Among the 6976 patients of reproductive age (3571 men [51%]; mean (SD) age, 42.5 [7.1] years), with reproductive age ranging from 18 to 40 years for 3405 women and from 18 to 50 years for 3571 men, clinics reported that 3036 of 6976 patients (44%) received counseling regarding the risk of infertility associated with chemotherapy. Women were more likely to be informed (1912 of 3405 [56%]) compared with men (1126 of 3571 [32%]) (P < .001). Factors associated with reduced likelihood of fertility risk discussion included male sex (odds ratio [OR], 0.73; 95% CI, 0.60-0.90), increasing age (OR, 0.93; 95% CI, 0.92-0.94), private practice setting (OR, 0.70; 95% CI, 0.53-0.93), and lack of multidisciplinary team planning (OR, 0.54; 95% CI, 0.41-0.70). Factors associated with increased likelihood of fertility risk discussion included having breast cancer (OR, 1.39; 95% CI, 1.12-1.73) and lymphatic or hematopoietic cancers (OR, 1.79; 95% CI, 1.33-2.40), participating in each subsequent study year (OR, 1.16; 95% CI, 1.08-1.24), receiving care in an academic clinic (OR, 1.45; 95% CI, 1.05-2.01), and being a practice offering clinical trial enrollment (OR, 1.60; 95% CI, 1.13-2.29). States with legislatively mandated coverage of fertility preservation had significantly higher rates of fertility risk discussion compared with states without legislation (48.6% vs 39.6%, P < .001). Conclusions and Relevance: The findings suggest that clinicians are more likely to counsel younger patients and female patients about reproductive risks before initiation of chemotherapy. State laws mandating fertility preservation coverage may be associated with improved frequency of fertility counseling before chemotherapy. Further awareness and implementation of ASCO guidelines appear to be needed to improve rates of fertility risk discussion and referrals to fertility specialists before chemotherapy.

Reasons for worldwide decline in male fertility.

PURPOSE OF REVIEW: To review the evidence regarding a decrease in worldwide sperm parameters and discuss potential causative factors. RECENT FINDINGS: The topic of worldwide decline in sperm parameters is contentious; however, recent high-quality studies have demonstrated that there is indeed a decline in sperm parameters. Several retrospective and basic science studies have shown possible links for this decline in sperm parameters such as obesity, diet, and environmental toxins. SUMMARY: There exist substantial data to suggest a decline in sperm counts over time. Although causative factors have yet to be fully elucidated, potential causes include, increased rates of obesity, poor diet, and exposure to environmental toxins. How this decline in sperm counts reflects fertility has yet to be determined. As such, further studies are necessary to evaluate whether this decline in sperm count correlates with decreased fecundity and how to identify and mitigate potential causative factors.

The development and comparative effectiveness of a patient-centered prostate biopsy report: a prospective, randomized study.

PURPOSE: The prostate biopsy pathology report represents a critical document used for decision-making in patients diagnosed with prostate cancer, yet the content exceeds the health literacy of most patients. We sought to create and compare the effectiveness of a patient-centered prostate biopsy report compared with standard reports. MATERIALS AND METHODS: Using a modified Delphi approach, prostate cancer experts identified critical components of a prostate biopsy report. Patient focus groups provided input for syntax and formatting of patient-centered pathology reports. Ninety-four patients with recent prostate biopsies were block randomized to the standard report with or without the patient-centered report. We evaluated patient activation, self-efficacy, provider communication skills, and prostate cancer knowledge. RESULTS: Experts selected primary and secondary Gleason score and the number of positive scores as the most important elements of the report. Patients prioritized a narrative design, non-threatening language and information on risk classification. Initial assessments were completed by 87% (40/46) in the standard report group and 81% (39/48) in the patient-centered report group. There were no differences in patient activation, self-efficacy, or provider communication skills between groups. Patients who received the patient-centered report had significantly improved ability to recall their Gleason score (100% vs. 85%, p = 0.026) and number of positive cores (90% vs. 65%, p = 0.014). In total, 86% of patients who received the patient-centered report felt that it helped them better understand their results and should always be provided. CONCLUSIONS: Patient-centered pathology reports are associated with significantly higher knowledge about a prostate cancer diagnosis. These important health information documents may improve patient-provider communication and help facilitate shared decision-making among patients diagnosed with prostate cancer.

Changes in risk-group stratification of patients undergoing radical prostatectomy at the Southern Alberta Institute of Urology over time.

INTRODUCTION: Prostate cancer is the most common cancer among men, but overall mortality rates remain low, due to the preponderance of low-risk disease. Over the last decade, there has been a shift toward more conservative management in low-risk prostate cancer, in order to minimize unnecessary intervention. This study aimed to evaluate the number of low-risk radical prostatectomies (RPs) being performed at the Southern Alberta Institute of Urology over a 10-year period. METHODS: We retrospectively reviewed all patients who underwent RP from 2005 to 2014 at our institution. Patients were stratified by D'Amico risk classification and grade group based on 12-core transrectal ultrasound-guided biopsy (TRUS-bx) results. RP findings are reported from February 2005 to October 2014 to describe concordance between TRUS-bx and RPs. Basic descriptive analyses were used for this study. RESULTS: Over the study period, 2,310 RPs were performed in our institution. Overall, 35.2% of these were performed on men with low-risk prostate cancer. From 2005 to 2014, the proportion of RPs performed for low-risk prostate cancer dropped from 54.0% to 8.9%, and 49.8% of patients who underwent RP for low-risk disease experienced pathologic upgrading, though only 3.8% were upgraded to grade group 3 or greater. Other adverse pathological findings were uniformly low among the low-risk group. CONCLUSION: The proportion of patients undergoing RP at our center for low-risk prostate cancer decreased significantly over the 10 years evaluated in this study, reflecting current global trends toward active surveillance in the management of low-risk prostate cancer.

The effect of time from biopsy to radical prostatectomy on adverse pathologic outcomes.

OBJECTIVE: To assess the impact of time between prostate cancer diagnosis on biopsy and definitive intervention with radical prostatectomy (RP) in regard to adverse pathologic outcomes using a large multi-surgeon database. MATERIALS AND METHODS: We retrospectively reviewed 2,728 patients who underwent RP between 2005 and 2014. Patients were stratified according to biopsy Grade Group (GG). Pathologic outcomes were evaluated for patients with <2 months between biopsy and surgery and then at monthly intervals of up to 6 months. Adverse pathological outcomes were defined as Gleason upgrading from biopsy, the presence of extraprostatic extension (EPE, pT3a) or seminal vesicle invasion (SVI, pT3b), positive surgical margins, and lymph node positivity. The chi-squared test was used for statistical analysis. RESULTS: In total 2,310 patients met the inclusion criteria. Median time from biopsy to surgery was 83 days (range: 61-109 days). No difference was observed for patients in any risk category regarding the adverse pathologic outcomes, including GG upgrade from biopsy to prostatectomy, presence of EPE, SVI, positive surgical margins, and positive lymph node involvement, with delays of up to 6 months between biopsy and RP. Surgical margins were positive in 25% of cases with pT2 disease and 50.2% of cases with pT3 and greater disease. EPE and SVI were present in 24.5% and 7.5% of specimens, respectively. CONCLUSION: Surgical delays of up to 6 months following prostate biopsy were not associated with an increased risk of GG upgrading, EPE, SVI, positive surgical margins, or lymph node involvement.

Impaired sleep is associated with low testosterone in US adult males: results from the National Health and Nutrition Examination Survey.

PURPOSE: Testosterone deficiency has been linked to several adverse health outcomes and recent data have suggested that abnormal sleep quality may result in lower testosterone levels. We assessed the effect of self-reported sleep patterns on serum testosterone while controlling for co-morbidities, and baseline demographics. MATERIALS AND METHODS: Using data collected from the 2011-2012 National Health and Nutrition Examination Survey (NHANES), we extracted serum total testosterone level, sleep duration, demographic, and co-morbidities for men aged 16 years and older. Univariate and multivariate linear regression was used to estimate the association of number of hours slept, co-morbidities, and demographics with serum testosterone. RESULTS: Among the 9756 individuals in the NHANES dataset, 2295 (23.5%) were males 16 years and older with a median (interquartile range) age of 46 years (29-62) who also had serum testosterone levels drawn. Median serum testosterone level was 377 ng/dL (IQR: 279-492 ng/dL). Median number of hours slept was 7 h (IQR: 6-8 h). On multivariate linear regression, we found serum testosterone decreased by 0.49 ng/dL per year of age (p = 0.04), 5.85 ng/dL per hour loss of sleep (p < 0.01) and 6.18 ng/dL per unit of body mass index (BMI) increase (p < 0.01). CONCLUSIONS: Among men aged 16-80 in the United States, we found increasing age, impaired sleep and elevated BMI is associated with low testosterone. It is important, therefore, that evaluation and treatment of reduced serum testosterone should also include improving sleep duration in combination with weight management.