Adele M. Caruso, DNP, CRNP

 is a nurse practitioner at the University of Pennsylvania Health System, Philadelphia. Urology Times blogs present opinions, advice, and news from urologists and other urology professionals. Opinions expressed by bloggers are their own, and do not necessarily reflect the views of Urology Times or its parent company, MJH Life Sciences.

Our country is in a state of national emergency due to the novel coronavirus, which causes the disease known as COVID-19. Advanced practice providers (APPs) across the nation are on the front lines caring for patients. This includes nurse practitioners and physician assistants who have advanced training and education in many areas of need to combat the COVID-19 pandemic. Urology APPs are doing their part!

The World Health Organization declared a global pandemic related to a novel coronavirus. COVID-19 is a respiratory illness with symptoms of fever, cough, and shortness of breath, different than coronaviruses that are already known. The first cases were reported in Wuhan, China in December 2019.

Coronaviruses in general can cause illness in both humans and animals, and it has been suggested that COVID-19 may have been transmitted to humans from bats, similar to SARS-CoV and MERS-CoV. The severity of the illness varies from very mild cases with minimal symptomatology to severe cases resulting in death. Older patients and those with comorbidities or are immunocompromised are at higher risk for developing severe illness (

NPs and PAs are highly qualified providers with advanced training and education and are an essential part of the health care work force. This is especially important to acknowledge as the majority of the nation is facing a physician shortage, and APPs are filling this gap with over 290,000 NPs and 140,000 PAs practicing nationwide (

). During this unprecedented time, it is crucial to safeguard access to care while ensuring we all stay safe.

APPs are keeping current with regular review of the full Centers for Disease Control and Prevention COVID-19 Guidance Updates (

) and as well as the COVID-19 Policy and Practice Updates disseminated by our government agencies, professional association boards, health systems, and private practices. This is quite the task with the plethora of communications on social distancing, personal protective equipment (PPE), ventilator availability, COVID-19 testing, therapeutics including hydroxychloroquine and plasma therapies, and potential vaccine developments.

While keeping abreast of daily updates, these sources adapt and modify treatments as new information becomes available. APPs, along with our physician colleagues, are on the front lines with managing and monitoring the spread of disease, delivering care, and executing treatment recommendations.

APPs are an integral part of the urology team and are filling administrative roles in handling the day-to-day divisional and departmental flow in an uninterrupted fashion. Urologist/APP teams are managing care seamlessly. They are providing care on site for those necessary or urgent appointments and procuring telemedicine encounters for necessary but non-urgent visits. Patient access to urologic care is being maintained during this COVID-19 pandemic thoughtfully, guided by evidence and expertise. Acute problems, as well as the bulk of crucial oncologic surveillance and treatment regimens, are being skillfully handled via telemedicine, in both the traditional telephone and virtual platforms.

APPs in urology are part of the “boots on the ground” with this triage process. They are calming fears and alleviating anxiety among urology patients who face postponement of surgical procedures. Amidst this pandemic and anticipating a “peak” sometime soon, many APPs either have been deployed or are preparing for deployment to another area of the hospital, location, or practice area to combat this pandemic. Urology APPs are serving on the front lines.

Barriers that limit APP abilities limit APPs’ ability to provide care. APPs are actively advocating for removal of practice barriers at both federal and state levels so they may better serve patients during the COVID-19 emergency. Due to the guidance of President Trump, every state is taking measures to relax regulations imposed on various health care professionals. The American Association of Nurse Practitioners, the largest association representing nurse practitioners of all specialties, is advocating and supporting various legislation to this end. The American Association of Physician Assistants is doing the same.

A recent success on the federal level was the signing of the Coronavirus Aid, Relief and Economic Security (CARES Act) into law by President Trump on March 27. This law strengthens seniors’ access to home health care services and provides needed funding for health care professionals. Most importantly, the law authorizes NPs and PAs to certify and recertify home health care services for Medicare patients, an authorization not previously permitted, strengthens funding for PPE, and secures other vital resources (

In Pennsylvania, regulations were relaxed, and health care professionals licensed under the Department of State’s 

Bureau of Professional and Occupational Affairs

 can provide telemedicine services during the COVID-19 emergency. Patients have access to telehealth and can receive care at home to eliminate the spread to the disease.

APPs are now able to practice telehealth across state lines. Additionally, governors of five states (New York, New Jersey, Kentucky, Louisiana, and Wisconsin) signed executive orders to enact full practice authority for NPs, which includes the removal of the restrictive barrier of a collaborative agreement, and also relaxed regulations for PAs, bolstering their respective health care work forces during this crisis.

Urology APPs are making an impact during this COVID-19 pandemic. Those deployed are using their individualized skillsets to care for patients. APPs with acute care training are taking care of the critically ill inpatients, and those with outpatient experience are posted in triage tents. They are serving regardless of risk to their own health, as are other health care professionals. They are maintaining patient access and managing health care needs. They are protecting patients and guiding them during this crisis.

They are advocating for the removal of regulatory barriers that prevent patient access to care. They are on the front lines and are fulfilling their professional commitment within their department and with deployments to alternate areas of need. I say, thank you to all of those APPs, urologists, and urology teams!

Do you have COVID-19 news to share? Please share your invaluable experiences by sending an email to 

Articles

"Urology APPs are making an impact during this COVID-19 pandemic. Those deployed are using their individualized skillsets to care for patients," writes Adele M. Caruso, DNP, CRNP.

Urology APPs: Making an impact during the COVID-19 pandemic

 is a nurse practitioner at the University of Pennsylvania Health System, Philadelphia. Urology Times blogs present opinions, advice, and news from urologists and other urology professionals. Opinions expressed by bloggers are their own, and do not necessarily reflect the views of Urology Times or its parent company, MJH Life Sciences.

Advocacy is an integral component of professional life for both advancing and promoting advanced practice provider disciplines, and also championing patient care issues within today’s health care system. So, let’s get active!

Merriam-Webster defines advocacy as “the act or process of supporting a cause or proposal,” while activism is “a doctrine or practice that emphasizes direct vigorous action especially in support of or opposition to one side of a controversial issue.” Advanced practice providers (APPs) provide quality health care in the United States and have demonstrated that they can improve much-needed access to health care for patients. It is imperative that APPs are active in advocacy for issues that remove barriers and ensure direct access to patients for their services.

According to the World Health Organization, “Health policy refers to decisions, plans, and actions that are undertaken to achieve specific health care goals within a society.” One of my favorite definitions is by Longest, who defines health policies as “authoritative decisions regarding health or the pursuit of health made in the legislative, executive, or judicial branches of government that are intended to direct or influence the actions, behaviors, or decisions of others” (Longest, BB. 

Health Policymaking in the United States,

 Sixth edition. Chicago, Health Administration Press, 2016). Be cognizant of health policies that affect health through health determinants and vice versa; these include physical environment, behavior and biology, social factors, and health services.

The BCG shortage: No short-term solution!

There are also the important extrinsic factors such as money for health care, the provider work force, and technology (Longest, BB. 

 Sixth edition. Chicago, Health Administration Press, 2016). As part of the expanding work force, APPs in urology care for the population health of patients with an array of genitourinary issues. By participating in advocacy and activism, we can support the policies we feel are in the best interest of our patients.

Understanding the phases of the policymaking process is key and includes the formulation phase of agenda setting and development of legislation, the implementation phase upon formal enactment of legislation, and the modification phase where all decisions in both these phases can be revisited and modified.

One must take into consideration the “window of opportunity” and external environment during this process. Know your political climate! This “window of opportunity” described by Kingdon opens when a confluence of problems, possible solutions, and political circumstances converge to stimulate legislation (Kingdon, JW. 

Agendas, Alternatives, and Public Policies, Update Edition, with an Epilogue on Health Care,

 Second edition. Upper Saddle River, NJ, Pearson Longman, 2011).

Nurse practitioners and physician assistants have health policy initiatives, and being familiar with these initiatives is imperative when called upon to articulate these agendas. Become familiar with current legislative objectives both regionally and nationally. If you are not already a member, join your professional association. Nurse practitioners and physician assistants have advocacy agendas for both professional and patient issues on their respective websites 

. You might also consider becoming involved with your state’s advocacy organization; eg, 

There are opportunities to advocate as an individual on both the state and federal levels, as well as advocate as part of an organization.  State advocacy is encouraged, and the AUA supports members to become effective state-level advocates to address legislation and regulations affecting their local communities. Federal and state legislative priorities are set annually and others may be considered as the need arises.

The AUA advocates for the specialty of urology and works at the federal and state level on behalf of its members and patients. Some 

 include preservation of access to appropriate PSA screening, reform of the U.S. Preventive Services Task Force recommendation process, and addressing work force shortages. Examples of 

 are medical liability reform efforts, support of efforts to reduce the burden of prior authorization, and support of legislative and regulatory efforts to expand meaningful patient access to telemedicine services.

Hematuria evaluation: Evidence for optimal practice?

How can you make a difference in your professional practice? How you can help patients through advocacy? I challenge you to stay informed and participate!

As always, please feel free to share your perspective by emailing me at 

"It is imperative that APPs are active in advocacy for issues that remove barriers and ensure direct access to patients for their services," writes Adele M. Caruso, DNP, CRNP.

Advanced practice providers: Make advocacy part of your professional life

 is a nurse practitioner at the University of Pennsylvania Health System, Philadelphia. Opinions expressed by bloggers are their own, and do not necessarily reflect the views of Urology Times or its parent company, MultiMedia Healthcare.

Bacillus Calmette-Guerin (BCG) intravesical immunotherapy is the most effective treatment for management of our patients with non-muscle invasive bladder cancer (NMIBC). What do we do without it, and how do we explain the current worldwide BCG shortage to our patients?

BCG intravesical immunotherapy is indicated in the form of intravesical installations for intermediate- and high-risk tumors following transurethral resection of the bladder tumor (TURBT). BCG significantly reduces bladder cancer recurrence rates while also impacting early progression rates. A risk-stratified approach is outlined in both the 

 guidelines for NMIBC according to low-, intermediate-, and high-risk tumors.

Per the AUA/SUO and EAU guidelines, post-TURBT mitomycin-C or epirubicin is recommended for low- and intermediate-risk patients. Additional induction intravesical therapy is not recommended for low-risk patients, post TURBT. In intermediate-risk patients, chemotherapy and immunotherapy is recommended. BCG immunotherapy is the recommended therapy for high-risk patients newly diagnosed with carcinoma in situ (CIS), high-grade T1, or high-risk bladder cancer.

In intermediate-risk patients responsive to chemotherapy or BCG, maintenance chemotherapy or BCG is recommended. The recommendation for high-risk patients is induction BCG and for BCG responders, a 3-year BCG maintenance regimen is recommended as tolerated. BCG induction without maintenance is associated with an 11% progression rate at 5 years 

In the absence of full availability, one would like to offer an effective alternative that optimizes patient access. Patients can be offered a one-third dose of BCG for induction and maintenance courses up to 1 year. This approach is based on a randomized trial by the European Organization for Research and Treatment of Cancer that showed no difference in progression rates between a full dose and one-third dose of BCG 

 Conservation of the medication requires three patients to be treated simultaneously, and coordination of this approach requires some administrative effort. Ideally, and for optimal efficacy, an induction of BCG course should be followed by maintenance if the drug is available. This is not generally not feasible during this current shortage. Other agents may be offered if BCG is unavailable or if administering one-third dose is not possible.

Alternatives to BCG include alternate intravesical immunotherapy and chemotherapy agents. One may consider an alternate immunotherapy agent such as intravesical interferon, which alone and in combination with BCG has demonstrated efficacy against bladder cancer. Chemotherapy alternatives to BCG include intravesical gemcitabine, mitomycin-C, and valrubicin (See 

AUA/Society of Urologic Oncology guideline

European Association of Urology guideline

"Alternatives to BCG Immunotherapy for Bladder Cancer Treatment During Drug Shortages."

A triage process is essential during this time of shortage. In a group practice, this requires a weekly review of the panel of bladder cancer patients in entirety. Patients are categorized by their pathology and assigned BCG therapy according to severity. Initiation of BCG maintenance therapy may not be an option during this time. If the patient is currently on maintenance, the recommendation is that BCG maintenance be stopped after 1 year, and for those high-risk patients with CIS, consider offering a reduced dose for years two and three 

). Maintenance BCG can be omitted for intermediate-risk patients and not utilized for low-risk patients. Patients not assigned BCG therapy are offered alternate therapies.

Will other strains eventually become available? The FDA is exploring opportunities to approve other strains; however, Merck is currently the sole maker and supplier, since Sanofi Pasteur suspended production in 2012. Companies in Japan, Canada, and Europe are working towards the development of new strains to thwart future supply shortages. (See 

"BCG: What to do when there is a shortage."

Many of our patients are in disbelief about the BCG shortage. The shortage is a major source of anxiety for them in addition to their bladder cancer diagnosis and disease management. How can we help our patients and offer them reassurance?

Shared decision-making presents opportunity for APPs

Open dialogue with your patients is the best way to offer support and reassurance and reduce patient anxiety. Provide the most up-to-date, evidence-based information regarding disease management and alternate therapeutic treatment options if BCG intravesical immunotherapy is not immediately available to them.

It may also be helpful to refer them to online resources such as the 

 websites. Moreover, the AUA’s website has a 

 called “BCG Shortage Info” that includes a “frequently asked questions” portion for your patients. This document provides clear and concise information. I recommend that you have this information readily available in printed form in your clinic. Additionally, the website provides an “office phone script” to assist staff with patient inquiries.

Merck, the only approved and sole supplier of BCG in the United States, expects the shortage to continue throughout 2019. Merck and their wholesalers and distributers adopted a distribution model based on supply and historical purchasing patterns, according to information on the AUA’s “BCG Shortage Info” page. This model is currently utilized when filling physician and hospital orders.

"Bacillus Calmette-Guerin (BCG) intravesical immunotherapy is the most effective treatment for management of our patients with non-muscle invasive bladder cancer. What do we do without it, and how do we explain the current worldwide BCG shortage to our patients?" writes Adele M. Caruso, DNP, CRNP.

is a nurse practitioner at the University of Pennsylvania Health System, Philadelphia. Opinions expressed by bloggers are their own, and do not necessarily reflect the views of 

 or its parent company, MultiMedia Healthcare.

Hematuria is a major reason for a clinic encounter, and the most efficient way to evaluate the condition is not always straightforward. While hematuria may represent serious genitourinary pathology, the majority of these evaluations will be negative. In this blog post, I will summarize current evidence and guidance for hematuria evaluation as it pertains to clinicians, including advanced practice providers.

Classic evaluation for hematuria consists of x-ray imaging of the urinary tract, endoscopic evaluation, and urine cytology. Careful assessment is required to rule out benign causes and, if ruled out, should prompt a urologic evaluation. The role of the advanced practice provider in the screening and diagnosis of both macroscopic hematuria and asymptomatic microscopic hematuria requires a proper workup, including ordering the diagnostic tests and prompt referral for cystoscopic examination.

Macroscopic vs. asymptomatic microscopic hematuria

Macroscopic hematuria is alarming to the patient. The dramatic presentation generally ensures compliance. Causes of macroscopic hematuria include asymptomatic or symptomatic stone disease, bladder cancer, and renal tumors. Of course, benign causes, such as infection, medical renal disease, menstruation, or recent urologic procedures, should be ruled out 

(AUA Guideline: Diagnosis, Evaluation and Follow-up of Asymptomatic Microhematuria (AMH) in Adults).

The obvious issue is asymptomatic microscopic hematuria. Asymptomatic microscopic hematuria is defined as three or greater red blood cells per high-power field on a properly collected urine specimen in the absence of a benign cause. According to the AUA guideline, a positive dipstick reading merits a formal microscopic examination.

As an alternative, urine dipstick has sometimes been obtained (not on the current AUA guideline) and is sometimes used to define asymptomatic microscopic hematuria as three or greater red blood cells on urine dipstick on two or more occasions. Although there is a 90% sensitivity rate, there is lower specificity with a higher false-positive rate, and the efficacy of urine dipstick is controversial (“Campbell-Walsh Urology,” 11

A concurrent nephrologic workup is warranted when medical renal disease is suspected or in patients taking anticoagulants despite the type or level of anticoagulation therapy. This is pertinent, as anticoagulant therapy is indicated for primary and secondary prevention of stroke, venous thromboembolism, and cardiovascular disease, but also associated with high rates of hematuria-related complications 

Age is a consideration. A cystoscopy is recommended for individuals older than 35 years while providers have the option to perform cystoscopy at their discretion in those under 35.As for those patients who are at high risk for genitourinary tract malignancies-individuals who are past and current smokers, have irritative bladder symptoms, have chemical exposures or chemotherapy or pelvic radiation exposure-a cystoscopy is recommended, regardless of age.

Computed tomography urography (CTU) is recommended for the upper tract evaluation (evidence strength grade C), according to the AUA guideline, to best evaluate the renal parenchyma and the urothelium of the upper tracts, and can detect approximately 90% of upper tract malignancies (“Campbell-Walsh Urology,” 11

How emotional intelligence can enhance the provider-patient relationship

As an option, according to expert opinion, when relative contraindications exist, magnetic resonance urography (MRU), magnetic resonance imaging with retrograde pyelograms (RPGs), non-contrast CT, or a combination of renal and bladder ultrasound (RBUS) and RPGs provides an alternative. Cystoscopy with bladder cytology is the standard. The use of urine cytology and urine markers is 

recommended as part of the routine evaluation for the asymptomatic microscopic hematuria patient and this is a recommendation based on evidence strength grade C; however, these may be useful for persistent asymptomatic microscopic hematuriafollowing a negative workup or in special circumstances.

Persistence also requires consideration. Persistence presents a special challenge as this condition may be associated with an enlarged friable prostate, Randall plaques (calcium plaques), or non-obstructing stones. Patients with a history of persistent asymptomatic microhematuria after an initial evaluation who have had two consecutive negative annual urinalyses do not require additional evaluation. For persistent asymptomatic microscopic hematuria after a negative workup, yearly urinalysis is recommended. If persistent or recurrent after initial workup, a repeat evaluation within 3 to 5 years should be considered. A small portion of patients will have disease or non-malignant disease detected on later evaluations. Provider judgment is key for reevaluation.

There is wide variation in the available data in regard to actual risk of malignancy, and also macroscopic hematuria risk versus asymptomatic microscopic hematuria risk. The risk of malignancy in patients who present with macroscopic hematuria is 20.4% compared to 5.2% in those who present with asymptomatic microscopic hematuria 

Bladder cancer surveillance: Challenges and opportunities

In the recent Detect 1 Clinical Trial of observational design, specifically in the macroscopic hematuria cases, 11% were found to have bladder cancer, 1.4% renal cancer, and 0.8% upper tract urothelial cancer 

Bladder cancer is the most common cancer detected in those who undergo an evaluation for asymptomatic microscopic hematuria (approximately 4.8%), versus renal cancer (0.3%) and upper tract urothelial carcinoma (approximately 0.1%) 

 Findings from 17 screening studies looking at asymptomatic microscopic hematuria revealed an overall urinary tract malignancy rate of approximately 2.6%, while rates in individual studies ranged from 0% to 25.8% inclusive of repeat testing of high-risk individuals 

The contemporary AUA guideline provides the basis for rationale care. This includes recommendations (evidence strength grade C),expert opinions, and clinical principles as well as guideline statements.It is essential to understand the nomenclature to be able to critically evaluate the guideline. The most effective approach for a particular patient is best determined by the provider and the patient. However, there is still room for further refinement, which may be provided by patient selection and newer technologies.

Balance expense (resource consumption) against inconvenience for patients. There is a high prevalence of asymptomatic microscopic hematuria with a low yield of underlying pathology. Economic consideration should also be regarded in the decision-making process.

In an original investigation, Halpern et al used a decision-analytic, model-based cost-effectiveness analysis to estimate the cost-effectiveness, costs, and incremental cost per cancer detected for four common diagnostic approaches for the evaluation of asymptomatic microscopic hematuria.Using a probabilistic sensitivity analysis, the combination of renal ultrasound and cystoscopy was found to be the most cost-effective, and the use of renal ultrasound in place of CTU as the first-line diagnostic strategy optimized cancer detection and reduced cost of evaluation 

Renal cancer follow-up: Find the happy medium

There is the cost of imaging, cystoscopy, provider visits, and time away from work to consider. One might consider individualizing care, but the current guideline does not allow for evidence-based risk stratification. Additionally, there are many patients with asymptomatic persistent microscopic hematuria after a negative workup. Future directions include urine markers and novel imaging. Does hematuria screening affect outcomes? There are few studies available.

CTU, MRU and IV urogram, and RPGs are the recommended modalities to assess the renal parenchyma and upper tracts due to their high sensitivity and specificity. This imaging complements the findings on cystoscopic examination, and there is value in examining the upper tracts. But a new investigation suggests that RBUS in conjunction with cystoscopy can safely replace CTU in patients who have asymptomatic microscopic hematuria. The study suggests that the use of something other than CTU may be worth evaluating further for this group of patients.

Conversely, CTU would remain the recommendation for those patients with macroscopic hematuria due to inferior sensitivity and negative predictive value of RBUS for UTUC (incidence of 0.8%) and renal cancer, as well as renal calculi 

Non-contrast CT would remain the preferred modality for those with suspected renal calculi.

However, the question remains: Should we consider a risk-stratified approach? Or more importantly, and within these certain parameters and certain settings, can other/alternate modalities safely supplant these traditional modalities?