Treatment Decision-Making and Symptom Management for Patients With Benign Prostatic Hyperplasia

Urology Times^®: With the range of treatment options available for benign prostatic hyperplasia (BPH), how do you work with a patient to arrive at the most appropriate therapeutic approach?

Gange: First of all, we try to quantify the symptoms. For starters, we rely on the validated IPSS (Interna­tional Prostate Symptom Score), the bladder scan postvoid residual, and urinalysis; in our office, IPSS is administered to every man aged 40 years and over, every visit. In patients who present with bothersome LUTS (lower urinary tract symptoms), their symp­toms are typically significant enough that the patients want to initiate therapy, and this is a reasonable starting point for further evaluation. I have a good ex­perience with minimally invasive surgical therapies (MISTs), especially with UroLift, and many patients come to me with that already in mind; this prompts a more comprehensive evaluation (obviously including PSA [prostate-specific antigen] measurement and prostate cancer exclusion).

Certainly, some patients prefer a trial of medical management, but others are inclined to move to a definitive intervention. Insurance requirements may dictate a period of trial and failure, or trial and adverse effects (AEs), related to drug usage. In reality, as I step back and look at the big picture, I’m not always sure that drug therapy is the right thing for many patients. Efficacy can be suboptimal, and I have increasing concerns about long-term AEs and negative or at least neutral impact on bladder health. We will try drug therapy when a patient requests it and when insurance requires it, but in most of our patients on straight or managed Medicare, there are no such requirements. If a pa­tient has CMS (Centers for Medicare & Medicaid Services)‑governed care, we can make the choice together to not try BPH drug therapy but instead move on to an evaluation for a definitive inter­vention. For me, this evaluation always consists of TRUS (transrectal ultrasound), flexible cystoscopy with retroflexion, and UroCuff PFS (pressure flow study); I perform these on the same day in order to maximize patient efficiency and office flow.

The 1-stop BPH evaluation has been very helpful. Often, we find that there is enough evidence of significant outlet obstruction and even early demise of bladder function, such that drug therapy wouldn’t have been in the patient’s best interest anyway. I work with patients to understand this dynamic; I provide to them a very detailed written overview of BPH and avail­able options as required reading. Patients have preferences, and we acknowledge their prefer­ences. Then we decide, with them, where to go next; I mostly rely on my experience and share my patients’ aversion to surgery, so after a com­plete evaluation, we move towards a minimally invasive option whenever possible.

Urology Times^®: What challenges emerge as you are working with patients to arrive at a suitable treatment plan? How might the urologist address some of these obstacles?

Gange: Right off the bat, many of the drugs have tolerability issues. The α-blockers are associated with dizziness, headaches, rhinitis, and ejaculato­ry dysfunction; some evidence also suggests a risk of dementia and ischemic CVA (cerebrovascular accident). The 5-α reductase inhibitors (5ARIs) particularly are associated with short‑and long‑term sexual AEs, and a study done by Veterans Affairs found an increased risk of prostate cancer.

On the other hand, I’ve become comfortable with tadalafil, which is dosed daily and is a very reasonable entry-level BPH drug therapy from an efficacy and safety standpoint. When patients tell me they want to try a drug because they are not ready to jump into procedural management, I often choose tadalafil. It’s now inexpensive and is very well tolerated with no known long-term consequences, and it also improves their erections. I like tadalafil for my patients with BPH. Yet even with this most tolerable option, many patients have no interest in drug therapy. Many men are on a number of other pills and have appropriate concerns about AEs and polypharmacy.

The other issues are related to insur­ance coverage. Some insurance compa­nies require patients to use conventional drug therapies, even when patients really resist a trial, prior to allowing a patient to undergo a MIST. There are some notable insurance companies that have 3-month or even 6-month medication rules before they allow us to move on to what the patient really came in looking for and would be best served by, which is the minimally‑invasive procedural option. Additionally, some carriers won’t allow MISTs based on some anatom­ical issues, despite FDA clearance. We counsel patients about their prostate size and shape and evidence of deteriorating bladder health as we perform the work-up; having a monitor in the procedure room really helps in this.

Urology Times^®: Can you describe the potential risks of opting for a “watchful waiting” approach or traditional medi­cations rather than procedural interven­tions for BPH?

Gange: Some of the problem has to do with follow-up patterns; I prefer close follow-up for men with LUTS who are initiating drug therapy. Even pre–COVID-19, men sometimes delayed follow-up appointments. If someone gets started on an α‑blocker for their BPH but doesn’t show up for a year or longer, by the time they come back, they may have discontinued the drug for AEs, and/or they may have progressed through the α‑blocker and developed some degree of detrusor dysfunction with urinary retention. Even if there is no retention, the bladder dysfunction that comes from ongoing obstruction can leave them with storage symptoms that they didn’t have at the outset. Generally, I think one of the risks is related to how some men approach their health care: they don’t always present when they have issues. If we don’t routinely quantify symptoms with IPSS, we may not appreciate what’s really going on.

Then the other risk, of course, is that with the passage of time and even with compliance, LUTS and detrusor dysfunction can progress. We are not always diligent as urologists in terms of monitoring our patients with BPH. Maybe we are not doing IPSS or postvoid residuals routinely. We might just ask how they are doing, and they’ll sometimes tell us that they are doing fine, when, in fact, they may have undisclosed complaints. If we don’t go any further, we might miss an opportunity to intervene when it’s appropriate. Historically, when TURP (transurethral resection of the prostate) was the only way to treat LUTS, men did fairly well. These days, TURP is often delayed until the point of urinary retention, and outcomes suffer.

Urology Times^®: The 2021 American Urological Association guidelines for BPH treatment recommend the use of IPSS at a visit during the 4- to 12-week follow-up period after treatment initia­tion. What is the role of IPSS tracking at your practice?

Gange: Although the recommenda­tions do not specify it be done at every follow-up visit, for me, IPSS is an every-visit thing. I think that can feel redundant, but it’s essentially a urol­ogist’s BPH blood pressure. We don’t have any real objective way, short of the PFS, to monitor a patient’s prog­ress on their therapy or posttherapy. I like IPSS a lot. IPSS implementation might seem cumbersome, but it isn’t. We just hand it to the patients, they fill it out in the waiting area, and a medical assistant imports everything into the medical record. We also leave the paper copy available, so when I walk into the room, I can get a general sense for where the patient is. I think it is an invaluable assessment tool and don’t know how I would practice without it.

By the way, IPSS is not the only way to do this; I also like the BPH Impact Index (BII).¹ I think it’s a little more general and qualitative; I use the BII in tandem with IPSS for my MIST patients to enhance my understanding in their recovery period.

Urology Times^®: If a patient is dissatisfied with their treatment or no decrease in IPSS is shown, what are the implications for therapy?

Gange: Occasionally, I think we have to talk to the patient to learn what they are really complaining about. I look not just at the assessment, the symp­tom score itself, but also at the quality of life (QOL) score. It’s interesting that sometimes we see the QOL score improve while the numbers they are circling at the top of the score sheets don’t seem to improve. Possibly, men are circling numbers out of habit or impatience. In other words, an accurate assessment does require a little qualifica­tion by a conversation with the patient.

This has also been where I have found the BII to be useful. I’ll see patients whose IPSS scores don’t move much, but if we have that other score, that other opportunity to ask these questions alongside the IPSS, sometimes we’ll see improve­ment in that score; it’s a matter of interpretation. In the long run, I do acknowledge a patient’s elevated score. If it’s not improving, I have to get into that with them and determine what’s really going on. There are times when we perform MIST and don’t decrease the score much but have been suc­cessful in discontinuing a twice‑daily α‑blocker, a 5ARI, and even a bladder drug; in my book, that’s a home run. Other times, we will substantially im­prove the patient’s voiding symptoms and essentially uncover the storage symptoms, which now become the predominant complaints. We have to see where the scoring has shifted. Overall, I still continue to like the tool. I don’t make treatment decisions solely based upon it, but it’s an indispensable adjunct to our overall assessment.

Urology Times^®: What are some unmet needs in the ways that BPH is currently managed? What kinds of adjustments to the current treatment paradigm might need to occur to address these issues?

Gange: I think it’s time for broad‑based patient education,whether by industry-funded DTC (direct‑to‑consumer) campaigns or a source potentially less “biased.” Men (and their caregivers) need to know that untreated BPH can have a significant impact on overall health, hopefully prompting earlier engagement with health care providers.

We can’t forget that at least 50% of patients with BPH are managed by primary care providers who have nothing in their toolbox other than stacking medications for these men. Urologists could have a huge impact by educating primary care providers to consider earlier referrals.

The minimally invasive therapies that exist are in many ways less toxic than traditional BPH medications, and “non-user” urologists might want to give these treatment options a closer look. Approaching everything in a stepwise fashion doesn’t always serve our patients well. They have to “try and fail”—what does that even mean? How long are we going to let them try and fail drugs while detrusor dysfunction may be progressing? Which drugs? How many months of each drug? Sometimes, we just have to use our seasoned exper­tise about how best to manage these men. We also really need to begin to pay better attention to the long-term AEs of traditional BPH drug therapy, which have become really concerning to me. Many of us have very little hesitation about moving from drug therapy that’s not totally hitting the mark and maybe predisposing to worrisome AEs to a minimally invasive therapy with few downsides that is really a definitive way of managing BPH.

In-office procedures offer patients clear advantages (reduced risk and cost) while maximizing the urologist’s efficiency. Self-administered nitrous oxide is a safe and effective adjunct for in-office MISTs.

Finally, our current BPH guidelines emphasize the importance of PFS as a part of the accurate assessment of BPH. Cystoscopy and volume assessment are just not enough, and it is conceiv­able payers might begin to add this requirement to prior authorization for MISTs or more invasive BPH therapies.

REFERENCE

1. Angalakuditi M, Seifert RF, Hayes RP, O’Leary MP, Viktrup L. Measurement properties of the benign prostatic hyperplasia impact index in tadalafil studies. Health Qual Life Outcomes. 2010;8(131):1-7. doi:10.1186/1477-7525-8-131