I am considering a new position. What should I look for in a benefits package?

A benefits package is an important piece of the puzzle when evaluating job opportunities. For physicians, the type of employer often affects what is provided. For example, many private medical practices provide very little in terms of traditional benefits. As a partner or shareholder, you operate more as an entrepreneur and must pay your own way when it comes to most benefits. Large hospitals and university hospitals often have a more robust benefits package, but you practice medicine as an employee. Private equity groups sometimes land more in the middle.

Regardless of whether you choose your own benefits or they are provided to you by your employer, these are the most common benefits physicians should look for.

Two to 3 weeks per year is common. An important question to ask is whether sick days and time off for continuing medical education (CME) are included in your PTO or if they fall into a separate category.

 Typically, reimbursement amounts range from $2500 to $3500 annually. Make sure to verify what items are reimbursable because many employer policies have caps on airfare and hotel expenses.

 Premiums, co-pays, and coinsurance are important, but be sure to give extra consideration to the deductible and out-of-pocket maximums. The deductible is the amount you must pay before the insurance starts paying. The out-of-pocket maximum is the most you will pay in a calendar year for your deductible, co-pays, and coinsurance. Once the out-of-pocket maximum is reached, the insurance plan will cover 100% of the costs above that amount.

 Most dental plans are standard in terms of deductibles, co-pays, and coinsurance. Pay attention to the annual maximum benefit. These typically range from $500 to $2000. This is the maximum amount the plan will pay for dental work within a calendar year.

Most plans have relatively low co-pays for eye exams ($10 to $20) and provide allowances ($130 to $150) for eyeglasses and contact lenses. Medically necessary contacts are often covered in full. Elective and specialty lenses will likely have a co-pay.

There are 2 types of FSAs: a health care FSA and a dependent care FSA. These accounts let you contribute pretax money and then spend it on qualified expenses. The maximum you can contribute to a health care FSA in 2021 is $2750, and the maximum you can contribute to a dependent care FSA is $5000. Use caution with these accounts because for most, money remaining at the end of the calendar year is forfeited back to the plan.

Employer-provided monthly benefit amounts vary. We recommend physicians have at least 60% of their predisability monthly income covered by an LTD policy. If the employer-provided plan is insufficient, then a physician should acquire a supplemental disability policy to make up the difference. When reviewing disability plans, pay close attention to how disability is defined. A “true own occupation” definition is a specialty-specific policy. If the employer-provided policy does not have this definition, consider getting as much coverage from a supplemental policy
as possible.

 Employers often provide coverage equal to 1 to 2 times a physician’s salary. Some limit coverage to $50,000, but that is done for your tax purposes. If an employer provides life insurance above $50,000, the premium paid for the insurance above $50,000 must be included in the employee’s income and they must pay income taxes on it.

 These retirement plans allow for tax-advantaged retirement saving and investing. In 2021, an employee can contribute $19,500 of their own money to the plan on a pretax or Roth basis. Employers often contribute by making a guaranteed 3% safe harbor contribution, matching a percentage of employee contributions or a mixture of both. Employers may also make discretionary contributions. Pay attention to the vesting schedule, which will tell you how much of the employer contribution you can take with you if you leave the company. You are always 100% vested in your own contributions.

Less commonly offered plans are a 401(a), a pension plan, and a 457.

Additional benefits you may have include a health savings account (HSA), short-term disability, accidental death and dismemberment insurance, adoption assistance, tuition reimbursement, wellness programs, and discounted services.

 is educational program director at MEDIQUS Asset Advisors, Inc in Chicago, Illinois. He welcomes readers’ questions and can be reached at 800-883-8555 or witz@mediqus.com.

The information in this column is designed to be authoritative. The publisher is not engaged in rendering legal, investment, or tax advice. If you would like assistance with your individual investment strategy, please email witz@mediqus.com.

Articles

CME reimbursement amount and 401(k)/401(b) are among elements to consider.

What to look for in an employment benefits package

Results from 2 years of follow-up in a prospective clinical trial demonstrate that sacral neuromodulation (SNM) using a rechargeable device (Axonics) provides durably safe, effective treatment for urinary urgency incontinence (UUI), according to the latest report from investigators in the ARTISAN-SNM trial (NCT03327948).

“The 2-year results are very impressive and underline what SNM can offer to patients with UUI. The clinical outcomes, along with the high rate of patient satisfaction, are testament to the effort the manufacturer invested into developing this technology,” said Andrea M. Pezzella, MD. “The rechargeable device has really raised the bar in the SNM treatment space. I am confident that the results of the study will raise awareness and encourage more physicians to adopt this therapy for long-term management of patients with UUI.”

Pezzella is medical director of Southern Urogynecology in West Columbia, South Carolina, and lead author of the published paper summarizing the 2-year outcomes of the ARTISAN-SNM trial. Patients were enrolled if they had 4 or more UUI episodes in a 3-day diary, including 1 or more episodes per day. A total of 129 patients (98% female) aged 21 to 86 years underwent device implantation in a single, nonstaged procedure.

Among 121 patients who completed the 2-year follow-up visit, 93% were judged to be “therapeutic responders” based on achieving a 50% or greater reduction in UUI episodes in a 3-day period. Eighty-two percent of the responders achieved at least a 75% reduction from baseline in UUI episodes, and 37% were dry (100% reduction). Mean number of UUI episodes per day fell from 5.6 at baseline to 1.0 at 2 years. There were no correlations between patient responses and either frequency of daily UUI episodes or time since diagnosis. “Particularly striking is that the responder rate was 88% in the rigorous as-treated analysis that included all study participants and classified anyone who had undergone explantation or exited the study for any reason as treatment failures,” Pezzella told 

Health-related quality of life was evaluated using the validated International Consultation on Incontinence Modular Questionnaire Overactive Bladder Quality of Life questionnaire and showed an improvement from baseline that was both highly statistically significant and clinically meaningful. Statistically significant improvements were also achieved in all subscale scores.

Responses on patient satisfaction questionnaires showed that at 2 years, 94% of participants were satisfied with the therapy and 93% said they would undergo the therapy again with the same expected results. Questions on device recharging showed 91% of participants considered it easy and 94% rated the frequency and duration as acceptable. Almost all participants (98%) reported recharging the device no more than once a week, and the duration of recharging was less than 1 hour for 88% of participants. These measures were stable throughout the 2-year follow-up.

“The patient satisfaction data should dispel any concern that patients would consider the need for recharging the device difficult, inconvenient, or bothersome, and an age-based analysis showed no differences comparing participants who were older than 65 years with their younger counterparts,” Pezzella said. “Recharging electronic devices is a fact of modern living, and with its short and infrequent charging sessions, the rechargeable SNM unit is very user-friendly.”

There were no serious procedure- or device-related adverse events (AEs). The most common device-related AE was uncomfortable change in sensation or magnitude of stimulation (9%), which was resolved through remote adjustments to the system. “The take-home message is that the rechargeable SNM has a very favorable safety profile, and the high rate of success has been, at least for me, a game changer in SNM that proves to be an invaluable treatment option for our patients,” Pezzella said.

Formal follow-up of patients enrolled in the ARTISAN-SNM trial has been completed. The manufacturer has established a postmarketing patient registry and will use the data collected to evaluate the real-world safety and efficacy of the rechargeable SNM system.

1. Pezzella A, McCrery R, Lane F, et al. Two‐year outcomes of the ARTISAN‐SNM study for the treatment of urinary urgency incontinence using the Axonics rechargeable sacral neuromodulation system. 

2021;40(2):714-721. doi:10.1002/nau.24615

“The 2-year results are very impressive and underline what SNM can offer to patients with UUI," said Andrea M. Pezzella, MD.

 Efficacy, safety of rechargeable SNM device for OAB sustained at 2 years

What are legal standards used to define medical malpractice? How do judges and juries decide which medical errors entitle a patient to bring a lawsuit? If a plaintiff alleges medical malpractice, what must he or she prove to recover damages? This article will provide an overview of what must be present for a malpractice claim to exist.

The idea that physicians are responsible for avoidable injuries to patients is nearly as old as the practice of medicine. The Code of Hammurabi sets out penalties for medical errors: “If the doctor has treated a gentleman with a lancet of bronze and has caused the gentleman to die…cut off his hands.” Thankfully, our system for addressing medical errors has changed significantly since Babylonia’s 3800 years ago.

The foundation for the modern approach to addressing medical malpractice was set in ancient Rome, where a person injured by a doctor could seek monetary compensation for economic losses and pain and suffering. The Roman system was the basis for English common law, which was the basis for the American legal system.

To win a malpractice case, a patient is required to prove 4 elements:

• the existence of a duty of care owed to the patient by the doctor

• a breach of this duty in the form of a departure from the standard of care

• a causal tie between the breach and an injury to the patient, and

• damages in the form of monetary costs, physical pain, and mental suffering.

To prevail, a plaintiff must show that it is more likely than not that each element is present.

With the first element, a doctor must exercise reasonable care in providing treatment to the patient. This is typically the most straightforward element for a plaintiff to establish. Although there are some exceptions, a duty is generally presumed to exist when a doctor treats a patient.

To establish a breach of duty, a plaintiff must offer testimony from a qualified expert to explain the standard of care required and how the defendant failed to meet that standard. The definition of 

 can vary. In general terms, it refers to the care that a doctor is reasonably expected to provide under the circumstances in the case. Importantly, the standard of care requires that treatment decisions are reasonable. Meeting the standard of care does not require that decisions are made with foresight and perfect accuracy. Doctors may disagree about what treatment option is best. Such disagreements do not mean that 1 treatment option is within the standard of care and the other is not.

A departure from the standard of care is legally insignificant without an injury. To establish the third element of a malpractice claim, a plaintiff must show a direct tie between a breach of the relevant standard and an injury. Expert testimony can usually establish that an injury would not have occurred “but for” the identified breach of the standard of care.

Finally, a plaintiff asserting a malpractice claim must show that the injury incurred is compensable. There are 2 recognized types of injury, or damages. First, there are economic damages, the monetary costs resulting from an injury. This includes the cost of subsequent medical care and lost wages. The other component is a plaintiff’s noneconomic damages, which comprise the pain and mental suffering associated with an injury. This type of loss is much more difficult to evaluate. What is the dollar amount that compensates someone for discomfort? What is the monetary value of the anxiety a patient experiences? The answers to these questions are entirely subjective. Ultimately, if a plaintiff can show that the other elements of their claim are present, a jury will determine the amount that represent fair compensation for an injury.

The framework explained in this article is designed to balance society’s interest in compensating persons wrongly injured by medical errors against the need to ensure that doctors are not held to an impossible standard of perfection. This system has been developed over thousands of years. It is unclear if we will ever find the perfect way to respond to medical complaints, but we can be certain that the justice system will continue to evolve.

 is an attorney in the Columbus, Ohio office of Reminger Co., LPA. He specializes in malpractice defense and insurance litigation. Please contact him at KSteele@reminger.com with any feedback or comments on this column.

Required elements to prove a claim include breach of duty and damages.

How is a medical malpractice claim defined?

The addition of onvansertib to abiraterone acetate (Zytiga) and prednisone yielded clinically meaningful activity in patients with metastatic castration-resistant prostate cancer (mCRPC) and early signs of resistance to abiraterone.

Data from a phase 2 trial presented during the 2021 Genitourinary Cancers Symposium showed that over one-third (35%) of patients across the 3 onvansertib doses had disease control at 12 weeks, the primary end point of the study. Further, one of the three onvansertib doses led to 63% of patients achieving disease control at 12 weeks.

Onvansertib is an oral PLK1 inhibitor. Research has shown that PLK1 is overexpressed in prostate tumors and is associated with higher grade prostate cancers.

The open-label, phase 2 study is exploring onvansertib in patients with mCRPC receiving abiraterone/prednisone and showing early signs of progressive disease. The study defined initial progressive disease as tests showing 2 rising PSA values separated by ≥1 week of the patients having minimal or no symptoms.

As of January 11, 2021, 51 patients had been treated across the study’s 3 dosing schedules, which comprised onvansertib at 24 mg/m2 (arm A; days 1-5 of 21-day cycles), 18 mg/m2 (arm B; days 1-5 of 14-day cycle), or 12 mg/m2 (arm C; days 1-14 of 21-day cycles).The results shared during the symposium included 24, 17, and 10, patients in arms A, B, and C, respectively.

Across all 51 treated patients, the median age was 72 years (range, 51-87), 86% of patients were White, and 84% had an ECOG performance status of 0. The median number of years since diagnosis was 4 (range, 1-28), the median baseline PSA was 11.4 ng/mL (range, 0.6-515), 57% were grade groups 4 and 5, and 37% had de novo metastatic disease. Visceral metastasis was present in 35% of cases, with bone metastasis occurring in 82%.

Across the 3 cohorts, there were 37 patients in the efficacy evaluable population, which included patients who completed at least 12 weeks of treatment or had disease progression within 12 weeks. Thirteen (35%) of these 37 patients achieved the primary end point of disease control at 12 weeks

In arm C, 5 (63%) of 8 evaluable patients had disease control at 12 weeks. This compared with 5 (29%) of 17 evaluable patients in arm A and 3 (25%) of 12 evaluable patients in arm B. Radiographic stable disease at 12 weeks was achieved by 6, 9, and 5 patients in arms C, A, and B, respectively. Three patients in arm C had a response lasting ≥6 months, compared with 5 patients each in arms A and B.

Over half (53%; n = 19) of the efficacy evaluable patients had 1 or more androgen receptor alterations associated with resistance to abiraterone. At 12 weeks, 5 of these patients achieved disease control and 8 had radiographic stable disease.

Safety data across all 51 treated patients showed that the combination of onvansertib and abiraterone was tolerable across the 3 dosing schedules of the PLK1 inhibitor. Grade 3 adverse events (AEs) occurring across the 3 dosing schedules were anemia (n = 1), neutropenia (n = 7), hypophosphatemia (n = 4), white blood cell (WBC) decrease (n = 3), and hypokalemia (n = 1). Grade 4 AEs across all doses included 2 cases of WBC decrease.

"The preliminary data presented at ASCO-GU support a clinically meaningful onvansertib exposure effect," principal investigator David Einstein, MD, attending physician at Beth Israel Deaconess Medical Center, stated in a press release. "In the first 8 patients treated to-date on Arm C, we are excited to see an increase in DCR with greater time on onvansertib, without excessive toxicity. Together with the clinically meaningful rates of disease control, and duration of disease control, we are seeing across all cohorts, these data demonstrate onvansertib's potential to address a critical unmet need for patients with abiraterone-resistant mCRPC."

1. Einstein DJ, Choudhury AD, Saylor PJ, et al. A phase II study of onvansertib in combination with abiraterone and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 39, 2021 (suppl 6; abstr TPS186). doi 10.1200/JCO.2021.39.6_suppl.TPS186

Abiraterone/prednisone can increase survival in prostate cancer; however, most patients develop resistance between 9 and 16 months after starting treatment. 


Onvansertib active in abiraterone-resistant prostate cancer

We have received a number of questions from those seeking advice on choosing a coding level when using the new 2021 evaluation and management (E/M) guidelines. The most common questions concern the meaning and interpretation of ideas within the 3 medical decision–making (MDM) categories: the complexity of presenting problem, data, and risk. We are dedicating this article to explaining some of the nuances of the new guidelines, giving our thoughts on the interpretation of many of the ideas. We also aim to advise how best to incorporate these concepts into the practice of medicine and improve chart documentation. Although we anticipate further discussion about the concepts in future articles, we hope this one will help clear up some of the most common initial areas of confusion. There may still be some adjustments to the interpretation from the American Medical Association (AMA) or the Centers for Medicare & Medicaid Services (CMS), as even they continue to answer thousands of questions. We will not be addressing time-based coding in this article.

Number and complexity of problem(s) addressed at patient encounter

In the 1997 E/M guidelines, the presenting problems section allowed a provider to add up points based upon the evaluation and management of new or established problems that were stable, worsening, or required further evaluation at the time of the patient visit; the sum of the points determined the final level for this section. In contrast, the level selected for this section in the 2021 E/M guidelines is no longer additive, but is now based upon the patient being seen for problems that are self-limited; acute or chronic; or stable, stable or worsening, or life threatening; or for one that is as yet undiagnosed and has an uncertain prognosis.The reason for this update is to compensate the health care professional for their thought process when evaluating a patient, and for their expertise with MDM regarding a patient’s treatment during an episode of care. Due to this update, providers will need to adjust their thinking and how they approach the problem(s) addressed section.

The part of this section that requires the greatest change is when providers address a new problem. In the updated guidelines, there is no specific category for new problem. Rather, if a diagnosis is made and it is acute or chronic, that is the level that should be chosen. The only term that specifically addressed new problem is that of “undiagnosed new problem with uncertain prognosis.” Providers should not choose this for all new problems, but rather only for new problems that are undiagnosed and require further evaluation with a differential diagnosis that includes a high risk of morbidity without treatment. Urology examples include patients who present with an elevated prostate-specific antigen (PSA) level, an abnormal prostate examination or prostate nodule, gross or microscopic hematuria, or a new onset flank pain for which a diagnosis cannot be made while they are in the office. The differential diagnosis in each of these examples includes diagnoses with a high risk of morbidity without treatment, such as underlying cancer. In contrast, examples that do not qualify may include patients who present with acute cystitis, a known ureter stone, or epididymitis, which, while may be new to the examiner, are either diagnosed at the time of the office visit or do not have a high risk of morbidity.

It is important to provide accurate documentation to support one’s thought process, in a way that gives a coder or auditor enough information to ensure that a chart is coded appropriately. Auditors may not be trained specifically in urology and therefore may not understand the implications of the provider’s thought process, so providing appropriate documentation will reduce the risk of an adverse audit. For patients who present with an undiagnosed new problem with uncertain prognosis, documentation should include the knowns and unknowns about the condition. This includes the potential next clinical step(s) for work-up to establish a diagnosis and the potential for morbidity of the diagnoses that may be found. Examples include the following:

 Gross hematuria may be due to both benign and malignant conditions, and the differential diagnosis includes trauma, infections, organ bleeding, and cancers. When a patient presents with gross hematuria, the next step in management depends on the patient’s history and circumstances. Therefore, documentation should support the provider’s thought process and the risks, and may include statements such as: “Gross hematuria (known) of unknown etiology (unknown): Plan is to schedule the patient for upper tract imaging and then to perform a cystoscopy to rule out kidney or bladder cancer (potential).”

 Similarly, a patient who presents with an elevated PSA could have both benign and malignant conditions and the differential diagnosis include prostate enlargement, infections, and prostate cancer. The initial evaluation for a patient with an elevated PSA may therefore qualify as an undiagnosed new problem with uncertain prognosis. Documentation to support this may include a statement such as: “The patient presents for an evaluation of a new finding of an elevated PSA as referred from their primary care provider (known). The most recent PSA is up to 5.5 ng/mL from about 2.0 in the past. The prostate exam today reveals no concerning nodules. I explained to the patient that this increase in PSA could indicate multiple problems (unknown) including prostate cancer or prostatitis (potential). After discussion, he agreed to try an antibiotic for 2 weeks and to recheck the PSA to rule out prostatitis as the cause of the PSA elevation. He will return after his repeat PSA, and if the level remains elevated we may need to proceed to a prostate biopsy. The patient will call if he experiences any progressing symptoms in the interim.”

Amount and/or complexity of data to be reviewed and analyzed

The data portion of MDM has generated a number of questions for us as well as the AMA, and requires clarification. A deeper dive into the guidelines offers further insight into the interpretation and proper use of items in this MDM category. Remember, data previously reported or ordered by the physician that are now reviewed cannot be counted a second time as data under MDM for a subsequent visit. Providers should remember that “independent interpretation of test performed by another physician/other qualified health care professional” requires more in documentation than simply stating that an outside image was reviewed. Rather, documentation must include the work performed, the independent interpretation of the data, and findings; these include abnormalities, if any, and relevant normal findings. Once again, the key to a successful chart is appropriate supporting documentation.

Risk of complications and/or morbidity or mortality of patient treatment

The risk category in the 2021 E/M guidelines was based upon the table of risk in the 1997 guidelines using the diagnostic procedure(s) ordered and management option(s) selected. Therefore, of the 3 MDM sections, the risk category is the one least changed and most familiar to providers. Once again, documentation of one’s thought process is paramount to accurate code selection and protection from an audit.

The AMA Current Procedural Terminology (CPT) guidelines define risk as: “the probability and/or consequences of an event. The assessment of the level of risk is affected by the nature of the event under consideration. For example, a low probability of death may be high risk, whereas a high chance of a minor, self-limited adverse effect of treatment may be low risk. Definitions of risk are based upon the usual behavior and thought processes of a physician or other qualified health care professional in the same specialty. Trained clinicians apply common language usage meanings to terms such as ‘high’, ‘medium’, ‘low’, or ‘minimal’ risk and do not require quantification for these definitions, (though quantification may be provided when evidence-based medicine has established probabilities). For the purposes of MDM, level of risk is based upon consequences of the problem(s) addressed at the encounter when appropriately treated. Risk also includes MDM related to the need to initiate or forego further testing, treatment and/or hospitalization.”

We would like to use an example that is common in urology to help highlight some thoughts when using risk: active surveillance for prostate cancer. A number of providers and coders have suggested that 99212 would be the appropriate code to use for all patients on active surveillance using the new E/M guidelines, as the patient would be coded using a level 3 presenting problem (1 stable chronic condition), level 2 for data (PSA), and straightforward risk (venipuncture). Although this conclusion may be correct for some cases, it is not correct for all, based upon the CPT definition of risk.

The table in the guidelines for risk provides risk examples; however, by itself, it is not intended to encompass the entirety of the guidelines but rather to provide a quick reference. When one considers the consequences of MDM for patients on active surveillance for prostate cancer, their risk may vary based upon other factors, such as age, family history, other signs and symptoms, pathology report, test results, and other health conditions. The provider must also consider the available treatment options and the risks associated with either intervention or continued monitoring of the patient. For some patients, the problem may be considered minimal, while others may be at a higher risk of progression or have a higher risk based upon their ability to tolerate a treatment. Although many patients on surveillance have straightforward risk, this is not the case with everyone. Using key words such as minimal, low, moderate, and high where appropriate in the documentation explains one’s thinking and helps in the communication with an auditor. Documenting in a way that shows a level of risk that other urologists would agree upon given the same situation may support a risk level.

In short, from an auditing perspective, a chart review is based on the information documented. If the patient’s full condition and diagnostic considerations are not well documented, it would require another urologist or someone with a deep clinical understanding of the conditions treated to interpret the true nature of the visit. Payers and the vast majority of coders will not take that step. Instead of leaving this interpretation to chance, we encourage clearly worded documentation to help support the selected risk level. This would protect one’s code choice in the event of chart reviews by insurers and help support appeals in the event of denials.

We recognize there may be areas of confusion when trying to understand the new 2021 E/M guidelines. For accurate code selection, providers must comprehend the true intent of the words in the guidelines at a deep level and also document the chart to support their thought process. There remains some ambiguity concerning the definitions, likely created by design due to medical care being individualized and based upon patient presentation and how a similar provider faced with the same situation might act. E/M coding cannot always be based on a single diagnosis or even a group of diagnoses. Instead, it must be based on the documentation of the patient presentation and the provider’s clinical thought process on the date of the visit. This deeper understanding of the guidelines should provide an opportunity for practices to reset their operational thinking so that the work, effort, and risk of a patient’s condition at their medical encounter is appropriately documented and therefore appropriately billed.

 is compliance officer and medical director of coding and reimbursement, United Urology Group and Chesapeake Urology, Towson, Maryland. 

 is CEO of PRS Urology SC in Denver, Colorado.

The information in this column is designed to be authoritative, and every effort has been made to ensure its accuracy at the time it was written. However, readers are encouraged to check with their individual carrier or private payers for updates and to confirm that this information conforms to their specific rules.

Providers must carefully outline their clinical thought process.

E/M guidelines require a different approach to documentation

Adding vibegron (Gemtesa) to treat overactive bladder (OAB) symptoms in men receiving standard first-line treatment for benign prostatic hyperplasia (BPH) is safe and effective, according to a study published in 

The study specifically assessed add-on vibegron in 42 patients who had persistent storage symptoms after being treated for ≥12 weeks with α-1 blockers (n = 22) or PDE5 inhibitor (n = 20) as frontline BPH therapy. The study met its primary end point with a significant decrease in Overactive Bladder Symptom Score (OABSS) between baseline and the completion of vibegron treatment at 12 weeks: 6.21 versus 4.38 respectively (

 <.001; higher results on OABSS indicate worse symptom severity).

Patients enrolled on the trial had an OABSS score of 3 or higher and at least 1 characteristic persistent storage symptom, such as urgency, urgency incontinence, daytime frequency, and/or nighttime frequency. The mean patient age at baseline was 72 years and the mean prostate volume was 40.6 mL. The α-1 blockers received for BPH/BPH-related lower urinary tract symptoms (LUTS) included silodosin (8 patients), naftopidil (10 patients) and tamsulosin (4 patients). The remaining 20 patients received tadalafil for BPH/BPH-related LUTS. The dose of vibegron administered was 50 mg once daily for 12 weeks.

Among their findings, the researchers noted that, “Although each score of several questionnaires, especially for storage symptoms, improved significantly, no significant improvement was found in stress incontinence, straining, bladder pain and urethral pain in the Core Lower Urinary Tract Symptom score. Maximum flow rate and residual urine volume did not change.”

The investigators also used statistical modeling to determine independent factors affecting the efficacy of vibegron. These factors were found to be prostate volume (

 = .028), monotherapy with α-1 blocker (

 = .007), and Core Lower Urinary Tract Symptom score (

Regarding safety, there were no patient discontinuations during the 12-week treatment period that were caused by treatment-emergent adverse events. The researchers did note in their paper that 4 patients, due to unknown reasons, did not attend their 12-week follow-up visit with their urologist.

The FDA approved vibegron in December 2020 for the treatment of adult patients with OAB with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.

The approval was based on the phase 3 EMPOWUR trial. In the primary study analysis, at 12 weeks, vibegron showed a mean change from baseline in the average daily number of micturitions of -1.8 compared with -1.3 for placebo and -1.6 for tolterodine (

The mean change from baseline in UUI episodes was -2.0, -1.4, and -1.8, respectively.

1. Ishikawa K, Tsujimura A, Miyoshi M, et al. Efficacy and safety of vibegron add-on therapy in men with persistent storage symptoms after receiving alpha 1-blocker or phosphodiesterase 5 inhibitor: a preliminary study [published online ahead of print on January 20, 2021]. 

2. Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB). Published online December 23, 2020. https://bit.ly/37I8SVc. Accessed February 10, 2021.

3. Staskin D, Frankel J, Varano S, et al. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. 

. 2020;204(2):316-324. doi: 10.1097/JU.0000000000000807

The investigators also determined independent factors affecting the efficacy of vibegron in this setting.

Add-on vibegron effective for OAB in men receiving standard BPH treatments

“It depends on the situation. If it’s an obvious situation, where the urinalysis is normal, there’s no postvoid residual, and it seems like classic stress incontinence, I don’t necessarily do urodynamics.

We typically do urodynamics when something’s unclear and confusing. I don’t always do urodynamics before doing a sling.

In the majority of cases that need a sling, where they need fewer than 5 to 6 pads a day, if for some reason the history is not clear, I would do urodynamics. If the history seems clear and reasonable, and there aren’t other issues, I don’t do urodynamics because it doesn’t really help me decide. I don’t do urodynamics unless it’s going to influence my decision or help the decision process in some way.

The decision process could indicate a patient may not be a good candidate for a sling. If, for some reason, you’re concerned there’s some other issue—involuntary contractions or another type of neurogenic component in his bladder—urodynamics can help identify that a person is not a good candidate for a sling. But in a straightforward case, I don’t necessarily do it.

Obviously, if the patient had infection, high postvoid residual, or a history of neurological issues, whether it’s a previous stroke or some other neurological condition that could influence bladder function, it’s a good tool to have if used in the right place.”

“I use urodynamics in my patients for several reasons. I want an objective evaluation of the severity of their outlet incompetence, giving me an estimation of their leak-point pressure. It provides good objective proof that it’s stress incontinence. A lot of patients suffer mixed incontinence, and if there’s a significant overactive bladder component that hasn’t been adequately addressed, oftentimes I address that first, to see if we can get the patient to a point where they have satisfactory control.

It also really provides a baseline reference so if they develop recurrent incontinence after a sling or an AUS [artificial urinary sphincter], I can repeat the study and have a look before they have anything done to compare to data after.

I have no objection to the approach of not doing urodynamics if it’s demonstrated the patient has stress incontinence and empties well. It’s not a requirement, but it’s a reasonable adjunct. Moreover, for patients who are considering a male sling as opposed to an AUS, it’s important we delineate the severity of their incontinence because the literature is replete with examples that slings are for patients that fit some strict criteria regarding their degree of incompetence.

Urodynamics allows me to have more confidence that we have properly selected those patients.

Urodynamics itself is incredibly low risk. There’s a small risk of infection but it’s more objective support that we’ve made an accurate diagnosis and we’ve objectively evaluated the severity of that diagnosis to guide the decision-making of the sling versus artificial sphincter.”

“We usually do urodynamics prior to doing either a sling or a sphincter. It’s part of the work-up to assess the capacity and compliance.

My partner does the sphincters, but I’m sure there are some situations where they don’t have any preoperative lower urinary tract symptoms with a relatively normal-sized prostate [and] normal-sized bladder and everything looks fine, [and]where they had no symptoms pre-op. [In those cases,] maybe they may consider doing it without urodynamics. But if you can you do the urodynamics, there’s little downside to doing it. You might end up with someone who has a noncompliant bladder or similar issues that you could treat prior to a sling or sphincter that might improve their symptoms, and which might be a contraindication to doing a sphincter.

You don’t want to block up a bladder that has really poor compliance because then the pressure is just transmitted to the upper tract. Usually, that would be like a neurogenic bladder, somebody with a lot of symptoms pre-op, so that’s going to be unusual.

You can also give them an idea of whether they have an element that’s not going to be necessarily treated with the sphincter. Sphincters are going to treat all stress-related incontinence, but if there is an element of urge, the patients might need to be on medication after surgery, so you can counsel them about that as well.

You can use urodynamics no matter what procedure you’re considering, but the sphincter would provide more back pressure than the sling in general.”

is in group practice and is an assistant clinical professor at Texas A&M University in Dallas, Texas, 

an associate professor of urology at the University of Arizona, Tucson, and 

is assistant professor of urology at Albany Medical College and urology section lead at Albany Stratton VA.

"We typically do urodynamics when something’s unclear and confusing. I don’t always do urodynamics before doing a sling," says 1 urologist.

Do you use urodynamics when determining when to insert a sling following a prostatectomy?

The American Society of Clinical Oncology (ASCO) has published an update to its guideline for initial hormonal management of noncastrate advanced, recurrent, or metastatic prostate cancer.

The latest guideline, which was published online in the 

, was developed by a multidisciplinary expert panel. The recommendations were made based on a systemic review of 4 clinical practice guidelines, 1 endorsement of a clinical practice guideline, 19 systematic reviews, 47 phase 3 randomized controlled trials, 9 cohort studies, and 2 review papers.

These are the recommendations established by the expert panel:

There are 4 standards of care for the initial treatment of noncastrate metastatic prostate cancer, consisting of androgen deprivation therapy (ADT) combined with either docetaxel, abiraterone acetate (Zytiga), enzalutamide (Xtandi), or apalutamide (Erleada). The treatments are indicated both as initial frontline treatment and in previously treated patients without disease progression. ASCO has no specific recommendation regarding sequencing or combining these 4 agents.

Rather than single-agent castration therapy, physicians “should consider” the combination regimen of ADT plus abiraterone and prednisolone in patients with noncastrate locally advanced nonmetastatic disease previously treated with radiotherapy.

In men presenting with noncastrate locally advanced nonmetastatic prostate cancer, immediate ADT is an option in men with no prior local therapy who are ineligible for or unwilling to receive radiotherapy.

Patients with high-risk biochemically recurrent nonmetastatic disease “may be offered” intermittent ADT.

Active surveillance is an option for patients with biochemically recurrent nonmetastatic prostate cancer that is low risk.

Across all noncastrate settings, ASCO does not currently recommend using either micronized abiraterone acetate or the approach of taking a reduced abiraterone dose with a low-fat breakfast.

Of the newer agents recommended for initial management, abiraterone was the first to be approved by the FDA. In February 2018, the FDA approved abiraterone for use in combination with prednisone for patients with metastatic high-risk castration-sensitive prostate cancer. The approval was supported by the phase 3 LATITUDE trial, in which there was a 38% reduction in the risk of death with the addition of abiraterone acetate and prednisone to ADT compared with ADT alone.

Next, in September 2019, the FDA approved apalutamide for the treatment of patients with metastatic castration-sensitive prostate cancer. The approval was based on the phase 3 TITAN trial which showed that apalutamide plus ADT led to a 33% reduction in the risk of death compared with placebo plus ADT.

The third of the newer agents approved in this setting was enzalutamide, which the FDA approved in December 2019 for the treatment of patients with metastatic castration-sensitive prostate cancer. The approval was based in part on the phase 3 ARCHES trial in which there was a 61% reduction in the risk of radiographic progression or death with enzalutamide plus ADT compared with placebo plus ADT.

The complete details and supporting data for this ASCO guideline are available in the full publication at

1. Virgo KS, Rumble RB, de Wit R, et al. Initial management of noncastrate advanced, recurrent, or metastatic prostate cancer: ASCO guideline update [published online January 26, 2021]. 

2. Fizazi K, Tran N, Fein LE, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. 

. 2017;377:352-360. doi: 10.1056/NEJMoa1704174

3. Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for metastatic, castration-sensitive prostate cancer [published online May 31, 2019]. 

. 2019;381(1):13-24. doi: 10.1056/NEJMoa1903307

4. Xtandi (Enzalutamide) approved by U.S. FDA for the treatment of metastatic castration-sensitive prostate cancer [news release]. Pfizer. Published December 16, 2019. https://bit.ly/2tpujIV. Accessed January 28, 2021.

Abiraterone acetate, enzalutamide, and apalutamide are highlighted among the standards of care for initial treatment.

ASCO publishes guideline update for initial management of noncastrate advanced prostate cancer

Relationship status and mental health are strong indicators of whether a man aged 18 to 31 might have erectile dysfunction (ED), according to a study published in the 

Compared with single men, those in this age group who were married/partnered had 65% lower odds of having ED. Men who used antidepressants were 3 times more likely to have moderate-to-severe ED. Anxiety and use of tranquilizers were also linked to increased odds of having moderate-to-severe ED.

Also of note, although only a small percentage (2%) of the study population reported use of ED medication or supplements, 29.7% of these men did not correctly use the treatment.

“Erectile dysfunction was common in a large sample of sexually active young adult men from a US cohort and was associated with relationship status and mental health. Health providers should screen for erectile dysfunction in young men, and monitor use of prescription erectile dysfunction medications and supplements for sexual functioning,” the authors wrote.

The investigators initiated the study because of the paucity of data regarding the relationship between physiological and psychological factors and erectile dysfunction in young men.

The study population comprised 2660 sexually active men aged 18 to 31 years from the 2013 Growing Up Today Study. The participants were all children of women in the Nurses’ Health Study II (NHSII).

The International Index of Erectile Function-5 scale was used by the investigators to define ED prevalence and severity, which were examined in cross-sectional survey data. Use of ED treatments was self-reported. Multivariable models were used to estimate links between moderate-to-severe ED and various patient demographic, medical, and mental factors.

The mean age in the overall patient population was 26 years, 39.9% were married, 20.3% were overweight/obese, 1.1% had diabetes, 6.3% had hypertension, and 7.7% had hypercholesterolemia. Regarding mental health history, 11.1% had depression and 8.4% had anxiety. Regarding treatment, 5.6% had used antidepressants within the past year and 2.3% had used a tranquilizer within the past year.

Overall, 300 (11.3%) of the 2660 patients had mild ED and 77 (2.9%) had severe ED. No ED was reported for 2283 (85.8%) patients.

The authors noted that their research did not show an association between metabolic factors or age and ED.

The researchers listed limitations of their study, including the limited racial/ethnic and socioeconomic diversity of the study population, and the reliance upon cross-sectional data.

“Moderate-to-severe ED was more prevalent among men who were not married or living with a partner, who reported using antidepressants, or who reported anxiety or using tranquilizers,” the authors wrote in their conclusion. “Given the high prevalence of mild to severe ED, research examining additional demographic, psychological, behavioral, and physical correlates of ED in diverse samples of young men is needed.”

1. Calzo JP, Austin SB, Charlton BM, et al. Erectile dysfunction in a sample of sexually active young adult men from a U.S. cohort: demographic, metabolic and mental health correlates. 

. 2021 Feb;205(2):539-544. doi: 10.1097/JU.0000000000001367

Compared with single men, those in this age group who were married/partnered had 65% lower odds of having ED. 

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