Implantable Penile Prosthesis for Erectile Dysfunction: Insurance Coverage in the United States.

INTRODUCTION: A manufacturer's benefit verification database was evaluated to ascertain United States health plan insurance coverage for implantable penile prostheses for erectile dysfunction. METHODS: All-payer and employer-sponsored health plan benefit verification databases were queried to determine implantable penile prosthesis approval status. For the all-payer analysis, data by payer were available and presented for 2019-2021 to assess approval status varied by payer and over time. For the employer-sponsored health plan analysis, data by payer were available from 2018-2021. RESULTS: Benefit verification records for the all-payer database were available for 3,167 patients in 2019, 3,016 in 2020, and 2,837 in 2021. Insurance type was preferred provider organization (27.5%), Medicare Advantage (26.9%), Medicare (15.9%), or point-of-service (10.5%). Most patients were approved or verified for implantable penile prosthesis coverage (79.4% in 2019, 79.6% in 2020, and 78.4% in 2021). Coverage was most extensive for government-based insurance (Medicare 98.7%, Medicare Advantage 97.1%, Tricare 100%, and Veterans Affairs 80.0%) but was also favorable for commercial insurance (75.0%). The most common reason for lack of coverage was employer exclusion; the proportion of patients with no coverage due to exclusion increased from 13.5% in 2019 to 17.5% in 2021. Analyses of the employer-sponsored health plan database (n=3,083 patients) showed that 63.1% of patients were approved or verified for coverage and 34.2% did not have coverage due to health plan exclusions. CONCLUSIONS: Approximately 80% of patients had implantable penile prosthesis coverage. Employer exclusion was the most common reason for lagging coverage; rates of employer exclusion increased 29.3% from 2019-2021.

Direct-To-Consumer Internet Prescription Platforms Overlook Crucial Pathology Found During Traditional Office Evaluation of Young Men With Erectile Dysfunction.

OBJECTIVE: To determine comorbidities in young men with erectile dysfunction (ED) who are increasingly targeted by direct-to-consumer (DTC) internet platforms that sell phosphodiesterase-5 (PDE-5) inhibitors without comprehensive clinical evaluation; and, further, to characterize the portrayal of DTC platforms by popular news media. METHODS: We retrospectively reviewed all men age ≤40 evaluated for ED at an andrology clinic during January 2016-March 2019 to obtain demographics, exam and lab findings, and treatments. Five news sources were analyzed during the study period to characterize whether articles about DTC platforms were positive, critical, or balanced/neutral. RESULTS: We identified 388 patients, with age 29.5 ± 5.0 years, 15% rate of obesity, 20% prediabetes or diabetes, 54% dyslipidemia, and 20% hypogonadism. Serum lab findings associated with subfertility were found in 11%. Semen analysis was conducted in 64 men, of whom 40% were abnormal. Varicoceles were found in 35%. PDE-5 inhibitor was prescribed to 328 men (88%). Off-label empiric therapies included clomiphene (32.9%) or aromatase inhibitor (12.1%). Testosterone replacement was initiated in 9.7%. Analysis of news coverage revealed 18 articles, of which 61% portrayed DTC platforms exclusively in a positive light. CONCLUSION: Office consultation identified young men with significant comorbidities that would be missed by DTC platforms, which employ only questionnaires for health screening. DTC platforms present themselves as medical authorities without following AUA Guidelines, yet garner mostly positive press coverage. Patients engaging these platforms may falsely believe they are receiving adequate medical assessment. Urologists may do well to incorporate telemedicine to enfranchise young men with evidence-based evaluation.

Efficacy of a preprostatectomy multi-modal penile rehabilitation regimen on recovery of postoperative erectile function.

To evaluate the efficacy of a novel, multi-modal, preoperative approach to postprostatectomy penile rehabilitation (PR), we performed a retrospective review of patients who underwent nerve-sparing robotic-assisted laparoscopic prostatectomy (NS-RALP). All patients were evaluated at a comprehensive, academic sexual medicine clinic between 2016 and 2017. The "prehabilitation" PR group (n = 106) consisted of men who were seen in the pre-op period and began tadalafil and L-citrulline 2 weeks prior to surgery. Vacuum erectile device (VED) therapy was started at 1-month post-op. These interventions were continued throughout the 12-month follow-up period. Individuals refractory to these therapies could start treatment with intracavernosal injections. The postprostatectomy PR group (n = 25) consisted of men who were not seen in the pre-op period and started the above therapies immediately following their first visit. A higher percentage of men in the prehabilitation group reported return of erectile function within 12 months (56% vs. 24%, P = 0.007). The prehabilitation group also showed better compliance with PR (PDE5i [96% vs. 64%, P < 0.001], L-citrulline [93% vs. 49%, P < 0.001], and VED [55% vs. 20%, P < 0.001]). Seventy-eight percent of men who attended 4-5 follow-up visits reported return of erectile function. Our results suggest that men undergoing a preoperative protocol show superior recovery of erectile function following NS-RALP. Further studies with prospective designs are warranted.

Decisional Quality Among Patients Making Treatment Decisions for Urolithiasis.

OBJECTIVE: To measure decisional quality, physician loyalty, and treatment preference in patients diagnosed with urolithiasis, a "preference-sensitive" condition, to identify areas of improvement to be addressed by a targeted shared decision-making intervention. METHODS: We identified patients who presented for an initial consultation for urolithiasis from March 2016 to May 2017. Patients completed a 24-item patient experience questionnaire after the consultation which assessed decisional quality domains, physician loyalty, and treatment preference. We summarized treatment preferences before and after the consultation and described the changes. RESULTS: Among the total of 113 patients who met inclusion criteria, 78 (69%) patients chose to participate. Thirty-six (46%) of those patients had evidence of decisional conflict and 42 (54%) did not. Only 1 in 5 patients experiencing decisional conflict reported knowing the benefits and risks of each treatment option. Patients with decisional conflict reported lower perceived shared decision-making, treatment satisfaction, and urolithiasis knowledge. Physician loyalty was lower among patients with decisional conflict as well. Thirty-nine percent of them were 'Promoters' of their urologist, compared to 71% of patients without decisional conflict. Sixty-four percent of patients without decisional conflict identified a treatment preference before consultation, while only 17% of patients who experienced decisional conflict were able to do so. CONCLUSION: Many patients with urolithiasis experience decisional conflict and are unsure of their preferences when making a treatment choice. Uncertainty can correlate with low physician loyalty after consultation. This population may benefit from a shared decision-making intervention that improves decisional quality while incorporating patient-specific preferences.

Time-Driven Activity-Based Costing Analysis of Urological Stone Disease.

INTRODUCTION: The documented increasing incidence of nephrolithiasis in the United States will likely be associated with significant economic impact. Time-driven activity-based costing is an analytical method that has been successfully adapted from industrial analysis for use in health care. Using this costing approach we characterized the cost of 4 stone treatment modalities at our academic medical center, including trial of passage, semirigid ureteroscopy, flexible ureteroscopy and extracorporeal shock wave lithotripsy. METHODS: We developed process mapping for urological evaluation, treatment and followup of renal or ureteral stones less than 10 mm in size for each treatment method. We calculated cost of resources, equipment, disposables, personnel and space used for each step in the process. Cost was based on the capacity of each resource and the amount of time required for the treatment process. RESULTS: The cost for trial of stone passage, $389, was expectedly lower than for surgical interventions and was mainly driven by clinic visit costs. Extracorporeal shock wave lithotripsy and semirigid and flexible ureteroscopy costs were $4,367, $4,830 and $5,356, respectively. Intraoperative disposables and personnel were the top contributors to overall treatment costs. CONCLUSIONS: Conservative management is less costly than surgical interventions. Flexible ureteroscopy is the most expensive of surgical interventions. We describe the first time-driven activity-based cost analysis of stone management to our knowledge. Identifying the main drivers of cost can help to improve the value of urological care and improve future cost-effectiveness analyses.

Cost-effectiveness analysis of treatments for metastatic castration resistant prostate cancer.

OBJECTIVE: Treatment options for metastatic castration resistant prostate cancer (mCRPC) have expanded rapidly in recent years. Given the significant economic burden, we sought perform a cost-effectiveness analysis (CEA) of the contemporary treatment paradigm for mCRPC. METHODS: We devised a treatment protocol consisting of sipuleucel-T, enzalutamide, abiraterone, docetaxel, radium-223, and cabazitaxel. We estimated number and length of treatments for each therapy using dosing schedules or progression free survival data from published clinical trials. We estimated treatment cost using billing data and Medicare reimbursement values and performed a CEA. Our analysis assumed US$100,000 per life year saved (LYS) as the threshold societal willingness to pay. RESULTS: Incremental cost-effectiveness ratios (ICER) for strategies incorporating sipuleucel-T that were not eliminated by extended dominance exceeded the societal threshold willingness-to-pay of US$100,000 per LYS, the lowest of which was sipuleucel-T + enzalutamide + abiraterone + docetaxel at US$207,714 per LYS. Enzalutamide + abiraterone + docetaxel exhibited the most favorable ICER among strategies without sipuleucel-T at US$165,460 per LYS. CONCLUSION: Based on the available survival data and current costs of treatment, all treatment strategies greatly exceed a commonly assumed societal willingness-to-pay threshold of US$100,000 per LYS. Improvements in this regard can only come with a reduction in pricing, better tailoring of treatment or significant enhancements in survival with clinical use of treatment combinations or sequences.

Heterogeneity of Outcomes in D'Amico Intermediate-Risk Prostate Cancer Patients after Radical Prostatectomy: Influence of Primary and Secondary Gleason Score.

AIM: The aim of this study was to clarify and examine the outcomes of prostate cancer patients classified as intermediate risk (IR) using the D'Amico risk classification system, specifically focusing on the influence of primary and secondary biopsy Gleason score (BGS). PATIENTS AND METHODS: An institutional review board-approved database of robotic-assisted radical prostatectomies performed after 2006 was stratified by standard D'Amico criteria. IR patients were then sub-stratified by BGS. Pathologic and intermediate-term biochemical disease-free survival (BDFS) outcomes were analyzed. RESULTS: Overall, 1,090 patients were classified as D'Amico low-risk, 896 as IR, and 240 as high-risk. Of the 896 IR patients, 63 had BGS 6, 630 were 3 + 4 = 7, and 203 4 + 3 = 7. Among IR patients, as the BGS increased, there was an increasing likelihood of extracapsular extension (21, 28, and 38%, respectively; p = 0.005), positive surgical margins (14, 26, 31%; p = 0.048), and worse 3-year BDFS (96, 94, 88%; p = 0.01). Multivariable logistic regression and Cox regression analyses confirmed differences among IR groups. CONCLUSION: D'Amico IR patients demonstrate significant heterogeneity in both pathologic outcomes and BDFS. IR patients with a BGS of 6 appear to have similar intermediate-term BDFS as low-risk patients. An increasing BGS from 3 + 3 to 3 + 4 to 4 + 3 results in a higher likelihood of locally-advanced disease and intermediate-term biochemical failure.

Decisional regret after robotic-assisted laparoscopic prostatectomy is higher in African American men.

OBJECTIVES: Longitudinal studies report racial disparities in prostate cancer (PCa) including greater incidence, more aggressive tumor biology, and increased cancer-specific mortality in African American (AA) men. Regret concerning primary treatment selection is underevaluated in patients with PCa. We investigated the relationships between clinicopathologic variables across racial and socioeconomic lines following robotic-assisted laparoscopic prostatectomy. MATERIALS AND METHODS: We assessed treatment decisional regret using a validated questionnaire in a total of 484 white and 72 AA patients with PCa who were followed up for a median of 16.6 months post-robotic-assisted laparoscopic prostatectomy. Socioeconomic status (SES) information was aggregated from 2010 US census zip code data. Perioperative clinicopathologic characteristics and functional outcomes were compared between groups. Univariate and multivariate regression analyses were used to evaluate the influence of race, aggregate SES, and other clinical and demographic characteristics on decisional regret. RESULTS: The majority (87.7%) of the population was not regretful of their decision to undergo treatment. However, a greater proportion of AA vs. white patients were regretful (20.6% vs. 11.2%, respectively; P = 0.03). AA and white men were similar on all functional, clinical, and pathologic features with the exception of younger age among AA men (56 vs. 60 y, respectively; P<0.001). Although there were significant differences in SES by race (P<0.001), regret did not differ by SES (ß =-1.53; P = 0.15). Race, postoperative sexual dysfunction, pad usage, and length of hospital stay, however, were significantly associated with decisional regret. CONCLUSIONS: AA men were more regretful than white men, after adjusting for clinicopathologic characteristics and postoperative functional outcomes.

Comparison of 3 upper tract anticarcinogenic agent delivery techniques in an ex vivo porcine model.

OBJECTIVE: To evaluate the degree of urothelial exposure using 3 upper tract delivery techniques in an ex vivo porcine model, to determine the optimal modality to locally deliver topical anticarcinogenic agents in patients with upper tract urothelial carcinoma. MATERIALS AND METHODS: An indigo carmine solution was infused into en bloc porcine urinary tracts to test the 3 techniques: antegrade infusion via nephrostomy tube, reflux via indwelling double-pigtail stent, and retrograde administration via a 5F open-ended ureteral catheter. Nine renal units (3 per delivery method) were used. After a 1-hour dwell time, the urinary tracts were bivalved and photographed. Each renal unit was evaluated by 3 blinded reviewers who estimated the total percentage of stained urothelial surface area using a computer-based area approximation system. In addition, as a surrogate for exposure adequacy, a validated equation was used to calculate the staining intensity at 6 predetermined locations in the upper tract, with lower values representing more efficient staining. RESULTS: Mean percent of surface area stained for the nephrostomy tube, double-pigtail stent, and open-ended ureteral catheter groups was 65.2%, 66.2%, and 83.6%, respectively (P = .002). Mean staining intensities were 40.9, 33.4, and 20.4, respectively (P = .023). CONCLUSION: Our results suggest that retrograde infusion via open-ended ureteral catheter is the most efficient method of upper tract therapy delivery. Larger studies using in vivo models should be performed to further validate these findings and potentially confirm this method as optimal for delivery of topical anticarcinogenic agents in upper tract urothelial carcinoma.

Abdominal approaches to pelvic prolapse repairs.

PURPOSE OF REVIEW: Abdominal sacrocolpopexy has been considered the gold standard for vaginal vault prolapse repair for several decades. Although transvaginal approaches gained popularity as minimally invasive alternatives, complications related to the use of vaginal mesh have led surgeons to perform these repairs less frequently. By incorporating laparoscopic and robotic techniques into the traditional open abdominal sacrocolpopexy, surgeons can offer the benefits of minimally invasive surgery while avoiding risks of vaginal mesh. This review article aims to evaluate the efficacy and outcomes of abdominal sacrocolpopexy by comparing open, laparoscopic, and robotic assisted laparoscopic surgery. RECENT FINDINGS: The excellent outcomes of open abdominal sacrocolpopexy have repeatedly been shown in published, randomized data. This has been further validated in minimally invasive techniques through randomized data evaluating the outcomes of laparoscopic sacrocolpopexy. Among the various sacrocolpopexy techniques, outcomes are similar among the open, laparoscopic, and robotic approaches. Minimally invasive surgeries have been shown to have advantages in terms of perioperative morbidity. SUMMARY: The superior outcomes of abdominal sacrocolpopexy are available using minimally invasive techniques for pelvic organ prolapse repair. Further research with randomized data is required to establish how these approaches compare to each other. Given the inherent advantages of minimally invasive surgery, robotic or laparoscopic abdominal sacrocolpopexy may become the preferred approach to abdominal pelvic organ prolapse repair.

Health literacy and disease understanding among aging women with pelvic floor disorders.

OBJECTIVES: Few studies on health literacy and disease understanding among women with pelvic floor disorders have been published. We conducted a pilot study to explore the relationship between disease understanding and health literacy, age, and diagnosis type among women with urinary incontinence and pelvic organ prolapse. METHODS: The study subjects were recruited from urology and urogynecology specialty clinics based on a chief complaint suggestive of urinary incontinence or pelvic prolapse. Subjects completed questionnaires to assess symptom severity, and health literacy was measured using the Test of Functional Health Literacy in Adults. Patient-physician interactions were audiotaped during the office visit. Immediately afterward, patients were asked to describe diagnoses and treatments discussed by the physician and record them on a checklist, with follow-up phone call, where the same checklist was administered 2 to 3 days later. RESULTS: A total of 36 women with pelvic floor disorders, aged 42 to 94 years, were enrolled. We found that health literacy scores decreased with increasing age. However, all patients had low percentage recall of their pelvic floor diagnoses and poor understanding of their pelvic floor condition despite high health literacy scores. Patients with pelvic prolapse seemed to have worse recall and disease understanding than patients with urinary incontinence. CONCLUSIONS: High health literacy as assessed by the Test of Functional Health Literacy in Adults may not correlate with patients' ability to comprehend complex functional conditions such as pelvic floor disorders. Lack of understanding may lead to unrealistic treatment expectations, inability to give informed consent for treatment, and dissatisfaction with care. Better methods to improve disease understanding are needed.

Outcomes of pregnancy following surgery for stress urinary incontinence: a systematic review.

PURPOSE: Although few data have been published on the safety of childbearing after surgery for stress urinary incontinence, a large proportion of physicians recommend that women wait to complete childbearing before pursuing surgical treatment for stress urinary incontinence. We systematically reviewed the available literature to examine the safety of pregnancy after stress urinary incontinence surgery, and to measure the effect of such pregnancy on continence outcomes. MATERIALS AND METHODS: The review was conducted according to the recommendations of the MOOSE (Meta-Analysis of Observational Studies in Epidemiology) group. We performed a systematic review to identify articles published before January 2011 on pregnancy after incontinence surgery. Databases searched include PubMed®, EMBASE® and the Cochrane Review. Our literature search identified 592 titles, of which 20 articles were ultimately included in the review. RESULTS: Data were tabulated from case reports, case series and physician surveys. The final analysis in each category included 32, 19 and 67 patients, respectively. Urinary retention developed during pregnancy in 2 women, 1 of whom was treated with a sling takedown and the other with intermittent catheterization. Of these 2 women 1 also had an episode of pyelonephritis during pregnancy, possibly related to the intermittent catheterization. The incidence of postpartum stress urinary incontinence ranged from 5% to 18% after cesarean delivery and from 20% to 30% after vaginal delivery. CONCLUSIONS: Although the data on outcomes in the literature are limited and further studies need to be performed on the subject, the current data suggests that any increase in risks for pregnancy after surgery for stress incontinence may be small. A low risk of urinary retention during pregnancy may exist. Although some data suggest that cesarean deliveries may result in a lower rate of recurrent stress urinary incontinence than vaginal deliveries, a formal analysis could not be performed with the available data.

Unnecessary imaging for the staging of low-risk prostate cancer is common.

OBJECTIVE: To quantify the rate of overuse of preoperative imaging procedures in a referral cohort of low-risk patients. International evidence-based best practice guidelines discourage routine imaging for staging purposes in low-risk patients with newly diagnosed prostate cancer. MATERIAL AND METHODS: An institutional database comprised of all patients undergoing robotic-assisted laparoscopic prostatectomy was queried for "low-risk" patients between May 2005 and January 2010. "Low-risk" was defined by the most inclusive criteria for imaging recommendations: prostate-specific antigen ≤10 ng/mL and Gleason score ≤6. We defined staging imaging as a bone scan, computed tomography (CT) of the pelvis or endorectal magnetic resonance imaging performed after the diagnosis of prostate cancer and before prostatectomy for the indication of "prostate cancer." Six-hundred seventy-seven patients were identified as having low-risk disease and comprised our study population. RESULTS: Of the 677 patients identified as low risk, 328 (48%) underwent at least one preoperative imaging procedure despite the guideline recommendations. Two-hundred two of 677 (30%) patients were administered at least 2 of the 3 modalities, and 18/677 (3%) patients received all 3 imaging examinations before prostatectomy. Suspicious results from the CT (7/265%, 2.7%) or bone scan (21/241%, 8.7%) resulted in 27 patients undergoing additional radiographic imaging, none of which resulted in suspicious lesions requiring intervention or biopsy. CONCLUSIONS: Despite international evidence-based guidelines for the staging of newly diagnosed prostate cancer patients, many urologists continue to refer low-risk patients for unnecessary imaging studies. This may place the patient at increased risk from radiation or contrast exposure and places an unnecessary financial burden on the patient and health care system.

Factors associated with improved neurologic outcomes in patients with incomplete tetraplegia.

STUDY DESIGN: Retrospective review of 412 patients with traumatic, incomplete, cervical spinal cord injuries, and an average follow-up period of 2 years. OBJECTIVES: To determine what patient characteristics, injury variables, and management strategies are associated with improved neurologic outcomes. In particular, the effects of intravenous steroids (NASCIS II protocol), early definitive surgery (<24 hours after injury), early anterior decompression for burst fractures or disc herniations (<24 hours after injury), and surgical decompression for stenosis without fracture were assessed. SUMMARY OF BACKGROUND DATA: Controversy surrounds the pharmacologic and surgical management of patients with spinal cord injuries. METHODS: Neurologic data were collected retrospectively and classified using American Spinal Injury Association guidelines. This information was recorded at the time of injury, on admission to rehabilitation, on discharge from rehabilitation, and at 1, 2, and final year of follow-up evaluation. Outcome measures included change in motor score, change in sensory score, final motor score, and final sensory score. The SPSS v10.0.7 statistical software package was used for data analysis. RESULTS: Neurologic recovery was not related to the following factors: gender, race, type of fracture, or mechanism of injury. Neurologic recovery also was not related to the following interventions: high-dose methylprednisolone administration, early definitive surgery, early anterior decompression for burst fractures or disc herniations, or decompression of stenotic canals without fracture. Improved neurologic outcomes were, however, noted in younger patients ( = 0.002), and those with either a central cord or Brown-Sequard syndrome ( = 0.019). CONCLUSIONS: The most important prognostic variable relating to neurologic recovery in a patient with a spinal cord injury is the completeness of the lesion. When an incomplete cervical spinal cord lesion exists, younger patients and those with either a central cord or Brown-Sequard syndrome have a more favorable prognosis for recovery. In this study, no evidence was found to support high-dose steroid administration, routine early surgical intervention, or surgical decompression in stenotic patients without fracture.

Changes in carotid artery blood flow during anterior cervical spine surgery.

STUDY DESIGN: Carotid artery blood flow was measured in 15 patients undergoing anterior cervical spine surgery. OBJECTIVE: To determine the effect of intraoperative retraction on carotid artery flow dynamics. SUMMARY OF BACKGROUND DATA: Adequate surgical exposure for anterior cervical discectomy and fusion necessitates prolonged retraction of the carotid artery. The perioperative effects of retraction on carotid blood flow have not been investigated. METHODS: Duplex ultrasonic measurements of common carotid artery flow velocity were taken in 15 patients undergoing anterior cervical discectomy and fusion. Measurements were recorded before surgery, intraoperatively after exposure was obtained and self-retaining retractors were placed, intraoperatively at the end of the procedure just before release of retraction, after surgery in the recovery room, and on postoperative day 1. Using flow velocity data, the changes in cross-sectional area were calculated at each time interval and expressed as a percentage of change in area from baseline measurements. The parameters of patient age, preexisting atherosclerotic vascular disease, and prolonged intraoperative retraction were analyzed to determine whether they were associated with the observed changes. RESULTS: Vessel cross-sectional area decreased an average of 14% with the initial placement of self-retaining retractors, and decreased further to 70% of baseline by the end of the case. Flow remained laminar at all times, and flow velocities returned to normal in the recovery room. Although these changes were more pronounced in the younger patients studied, and appeared to be only moderately attenuated by the presence of mild preexisting atherosclerotic vascular disease or prolonged vessel retraction, these observations could not be statistically confirmed because of the small number of patients in each subgroup. CONCLUSIONS: Intraoperative retraction during anterior cervical spine surgery alters common carotid artery flow dynamics by causing a significant reduction in vessel cross-sectional area. These changes are most pronounced in young patients. Atherosclerotic disease is a common finding in patients evaluated for anterior cervical discectomy and fusion.