Philip M. Hanno, a Urology Times editorial consultant, is professor of urology at the University of Pennsylvania, Philadelphia.

Philip M. Hanno, MD, MPH

The evolution of urology has trended toward subspecialization, with a smaller number of urologists performing the majority of certain procedures. In this interview, 

 discusses subspecialization, its benefits for clinicians and patients, and what the future “office urologist” may look like. Dr. Palese is chair of the Sol and Margaret Berger Department of Urology at Mount Sinai Beth Israel and Mount Sinai Downtown as well as professor of urology at the Icahn School of Medicine at Mount Sinai in New York. He was interviewed by Urology Times Emeritus Editorial Consultant 

 clinical professor of urology at Stanford University School of Medicine, Stanford, CA.

Back in 1980, when I finished my fellowship, the beauty of going into urology was that you could get a handle on virtually the entire field and feel comfortable doing almost anything. What do you think has happened since then in terms of subspecialization?

I think it’s a dramatically different environment for urologists in training. Our residents are certainly exposed to many areas of urology, but many of them will go on to practice and never do these areas again. This is going to be an issue going forward. We’re training our newest doctors to handle cases that they probably will never want to do or even have the ability to do in the future simply because the practice of health care is changing so dramatically. We are subspecializing so much with our areas of interest that it becomes impossible to do these kinds of cases.

This is a topic that I was looking at when my colleagues and I were reviewing a New York State health care database called SPARCS 

 It’s a very unique database in that it has information from all carriers-Medicare, Medicaid, commercial carriers, etc. It allows us to look at the practice patterns of urologists, and all physicians for that matter, over the last 30 years. We have not only inpatient data but also outpatient data and even emergency room data. With these data, we were able to see and track physicians and patients through those 30 years and figure out exactly who’s going where and who’s performing what surgeries.

Although New York State is not the entire United States, it is still a microcosm of what happens in health care now. I think a lot of the patterns we’re seeing can be applied to what’s happening around the U.S.

For starters, we looked at what are considered the major inpatient cases: radical prostatectomy, partial nephrectomy, radical nephrectomy, and radical cystectomy. These are the types of cases that still require an inpatient stay if not 24 hours then potentially 2 or more days. The way that health care has changed dramatically in urology is that more and more of these are being pushed into ambulatory or 23-hour stay situations. A lot of cases are actually even going to the office.

We looked at the last 30 years to see who is performing these surgeries and at what level and what volume. Interestingly, we found that even though the volume has increased, the number of surgeons in general has gone down. That means that the number of cases each surgeon is doing has gone up dramatically. For instance, looking at prostatectomy, the top 5% surgeons in the state of New York in terms of volume do almost 50% of all prostatectomies currently. That top 5% represents maybe 10 to 12 surgeons.

Do you think this applies internationally as well?

We don’t have any international data simply because this is a state-based database. I suspect that internationally we’re starting to see some of these patterns changing as well, because the amount of time that you need to get very good at a certain procedure, the amount of time you need to master a certain technique and use the technology appropriately, is changing. The ability to do these cases and pick them up right out of residency is falling by the wayside. You really have to specialize, do a fellowship, do extra training. It’s becoming tougher and tougher for the community urologist to do these types of cases.

That leads me to my next question. What are the implications for training programs? Is it worthwhile to train everyone to do everything?

That’s one of the things we looked at in this study. If we only have a small handful of urologists to do these major inpatient cases, why should we put our resources into training everybody to do them? Perhaps we should be thinking about making “mini-fellowships” within our residency programs much the same way that plastic surgery and vascular surgery have done. You would have “general urology” time, but then you would branch out during the last 2 or 3 years of your residency, so it’s already a specialization within our specialty.

"We probably have to look at board certification again."

Do you think that area of expertise is more important than your boarded specialty?

We probably have to look at board certification again. There are certain specialties, such as anesthesia, that have gotten rid of board recertification. Why would we continue to demand that urologists are proficient in all areas of urology like pediatrics or infertility when they will never practice or see these types of patients in the future? Perhaps we need to be thinking about recertification or boards that are subspecialty specific.

Has this subspecialization change been driven more by patients and social media or by urologists who want each patient to see the person best suited to treat their individual problem?

I think it’s a combination of the two. We know very well that the higher volume surgeon and the higher volume center tend to have fewer complications and fewer issues with morbidity and mortality. This has been shown over and over again, not only in urology but in other medical specialties as well. It’s just the evolution of health care.

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As we have grown, so the days of the individual physician working as a private practitioner with a shingle on the door are numbered, if not already dead at this point. It behooves you to be part of a large group, and so there are large practice groups and large academic groups. Because of that, we now have groups of anywhere from 20 to 40 or 100 or more urologists. It would make sense then to have a few individuals do certain things and those urologists would elevate a standard of care that is well above what was previously being done.

The other side of this is that as physicians are finding ways to compete against each other, social media certainly has played a role and patients are much savvier about trying to find physicians by looking at their Press Ganey scores and learning about their reputation online, so we have certainly become much more of a customer service-oriented industry than we’ve ever been before.

That makes it much harder for the person just going into practice who doesn’t have that backlog of cases when a patient asks: How many have you done?

Correct. It’s amazing how often we hear that in New York City, where patients can find experts within 20 blocks of each other. It’s one of the first questions we get from patients. That by itself has already created a situation where physicians really need to focus on one area in particular that they do well.

What advice would you give to a urologist who’s been in practice for 1 year and is asked that question?

I think you just need to be honest and say, “I’ve trained in this area, my mentor is so and so, and I’m in a high-volume center where we do ‘X’ amount of cases per year. I’m very comfortable doing this procedure and if there is a situation that arises, I have lots of back-up to help me out.”

"We have people who are now subspecializing just in MRI-focused biopsy"

Do you think this subspecialization trend applies now to non-surgical as well as surgical fields within urology?

Absolutely. We’re seeing this not only in inpatient volume but also in outpatient volume; for instance, infertility and pediatrics, and even areas that are a little more modern such as MRI-focused biopsy. We have people who are now subspecializing just in MRI-focused biopsy because it’s so labor intensive and there are complexities to it.

To what extent is this trend related to reimbursement per unit of care? For instance, cystectomy seems more and more to be relegated to academic centers of excellence, not only because the results are better but because it’s so time-consuming to operate and take care of these patients for the private-practice urologist that it almost becomes not financially viable. Do you think that’s a driving force?

Absolutely, that’s part of it. It’s not only a financial decision but also a resource decision. In a large academic center, we have many more resources to deal with these patients who tend to be very sick or have potential long-term complications or issues. For a private practitioner, spending 6 hours on a cystectomy instead of 6 hours in the office is a world of difference in terms of financial reimbursement. This is the future of urology; why train all of our urologists to do cystectomies when there are only a handful who are going to be doing them?

 study, you noted that in Germany, subspecialization within urology has led to the creation of the “office urologist” whose activity is restricted at the end of training to diagnosis and non-surgical treatments or a limited range of surgical treatments. This practice structure is also being explored in England. Do you see this happening in the U.S., or is this more the role of the nurse practitioner/physician assistant or physician extender by and large?

I think there will probably be a combination of such. What’s been happening is a lot of our more senior urologists who are less excited to go to the operating room every day have become more like office urologists, which is wonderful because we have an experienced urologist in the office who understands these cases. That’s the nice thing about urology; we have a lot of leeway in terms of how we can continue to practice well into our later years. Interestingly enough, some of the insurance companies are already looking at insuring urologists based on how many cases you do in an inpatient setting versus an outpatient setting as well as office-based volume.

"There are so many complexities and split-second decisions that are made in surgery that I’m not sure a computer can accommodate just yet"

We had an interesting lecture at Stanford on computers like Big Blue and their role in medicine. The speakers said that while computers may be able to take over many cognitive activities, it’s unlikely they’ll be able to operate on patients in the foreseeable future. The thrust of the lecture was that people who went into cognitive specialties would have more to lose to computers in the future than those who were in surgical specialties. What are your thoughts about that?

It’s very interesting. I saw a segment on “60 Minutes” on Big Blue where the supercomputer was used during a medical oncology tumor board. Big Blue searched the entire world for appropriate clinical trials and treatments. There’s no way that any individual person could possibly know all of those trials and treatments. That goes hand in hand with what we’re discussing.

I do believe that, yes, surgical skills are still going to be in the hands of surgeons. There will be assistance, just as we use robots and MRI-guided technology now, but ultimately, the final decision will continue to be with the surgeon. I see that continuing in the foreseeable future.

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There are so many complexities and split-second decisions that are made in surgery that I’m not sure a computer can accommodate just yet. That being said, there are probably ways for a computer to figure that out as well; for example, what the odds are for certain things to happen based on the anatomy, and the factors involved.

What effect do you think subspecialization could have on unnecessary surgical procedures? 

I think there’s always a risk for someone doing surgery when they don’t need to be doing so. Presumably, if someone is highly specialized in an area, they wouldn’t want to embark on a procedure that doesn’t make any sense. Subspecialization may be a way of making sure that surgeries are done for the right reasons. But like any procedure or any financially goal-oriented system, there are always going to be people who will take advantage.

Do you think that major changes in training with earlier subspecialization in mid-residency will be the way things move along?

I think we’re going to have to seriously consider it. It makes sense, certainly with the way we are providing health care and the way we’re using our resources. Look at what’s happened with bariatric surgery. You cannot perform bariatric surgery except in a center of excellence that’s been sanctioned to do so. I see robotic surgery not far behind this. I can’t imagine that it makes sense for every little hospital to own a $2- or $3-million robot to support surgeons who do five or six cases per year; the robot really needs to be in the hands of surgeons who do a lot of volume and understand how to move through the cases quickly and safely. The resources we have are limited, so why would we spend them on surgeons who, frankly, just shouldn’t be doing these cases?

How does subspecialization impact costs of care?

In a lot of ways, it may save quite a bit of money, because we are now creating a better outcome. Presumably, patients are getting the best care possible with minimal potential for morbidity and mortality based on the fact that the surgeons who are doing these procedures are well experienced. Again, why should a low-volume surgeon use up resources and presumably drive up the cost of something if another surgeon who can do the same procedure three or four times over in that same amount of time? We really need to look at this, and I think a lot of the operating rooms around the country are starting to look at how much time surgeons take, what kind of products they use in the operating room, how much each case costs them. This is the future of urology, no question.

What do we lose by giving up the general urologist?

Like everything else in life, as things become more complex and more complicated, we are going to have people who understand certain areas very, very well, and it’s going to be important to make sure that the general urologist still exists. That general urologist may not be a urologist anymore. It may be a nurse practitioner or a physician assistant. It may be a primary care doctor who delves into urology. Not so long ago, family practice doctors were doing cystoscopies in their offices. We’re seeing less and less of that now. But it existed in the past and I see a reason at some point it might come back to that.

So in the future, you could have a training path where someone goes through general medicine training and then does a year of urology.

Correct. They would get a basic urology background, which is not such a bad idea; you would have a physician who is trained in other areas, not just urology but in general medicine.

The switch to OTC: Are urologic drugs next?

I think as urologists we’re always worried about giving up certain procedures to other specialties, but as these things become more complex, it’s a natural evolution that we just embrace new technologies and new techniques. It’s not that we’re going to lose our specialty, we’re just going to make it better.

Is there anything else you would like to add?

One of the other areas my group has studied is patient travel (2015 AUA annual meeting study). Patients are much more willing to travel for care than ever before. We looked at studies back in the 1980s where if people were offered a really good doctor 5 minutes from their house or a really great doctor 30 minutes from their house, the majority of patients would go to the good doctor who is 5 minutes away because they felt that they would get a basic standard of care and it was more convenient for them to travel those 5 minutes.

It’s very different nowadays. The average patient will travel well over 100 miles to get to wherever they need to go, especially if they have a specialty issue. In our study, even if patients live in the tip of New York State, they would come down to New York City thinking that they’re getting better care there. I suspect this is a travel pattern that we’re seeing not just in New York State but in other areas of the United States. This reinforces the argument for subspecialization and regionalization of care to large-volume surgeons and centers.

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In this interview, Michael Palese, MD, discusses subspecialization, its benefits for clinicians and patients, and what the future “office urologist” may look like.

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Roger Dmochowski, MDSwitching a medication from prescription to over-the-counter status comes with challenges and risks, and is not always successful. In this interview, 

 discusses the pros and cons of OTC medications and explains the hurdles facing potential OTC products for urologic conditions. Dr. Dmochowski is professor of urology and gynecology at Vanderbilt University Medical Center, Nashville, TN. He is a prior member of the FDA Bone, Reproductive and Urologic Drugs Advisory Committee. He was interviewed by 

For the last 25 years, I have been involved in assessment of phase I trials, phase II and phase III study design and conduct, as well as regulatory assessment and oversight thereof through the FDA. I have kept up with a lot of the recent changes and evolving treatment concepts, especially around benign functional urology, which has to do with symptomatic conditions and how best to measure outcomes from the objective and the patient-reported outcome (PRO) standpoint. I’m happy to say that I was involved in the recent development of a drug, desmopressin nasal spray (Noctiva), where the development process included the use of a novel PRO instrument.

Forty percent of all over-the-counter drugs in the U.S. today were once prescription drugs. Most OTC products are not covered by insurance, resulting in higher out-of-pocket costs. Some of this cost increase is balanced by reduced medical service use and less time away from work. What are your thoughts on this conundrum?

There is relative value to some products being OTC. Certainly, given the current constraints in development and what is asked of a switch from prescription to OTC status, I find the controls to be very interesting, specifically because they are so patient-centric. One of the concerns when anything goes OTC is how it is really going to be used if it’s put into the public domain. Patient safety is critical, as is the importance of patient literacy concerning the condition being treated and also the formulation being taken.

Increases in medical service use following prescription-to-OTC switches may reflect product substitution. The absence of insurance coverage for OTC products may induce some individuals to seek covered prescription substitutes, resulting in more physician visits to obtain new prescriptions or failure to take any medicine at all. What are your thoughts on this?

I think that is a valid concern. One of the things that OTC medications allow is essentially a presumptive trial for management of a person’s condition. As an example, I started using, unfortunately, quite a bit of OTC anti-reflux treatments just because I didn’t want to have an esophagogastroduodenoscopy. I believe the potential for inappropriate use of OTC agents exists and their use potentially could increase costs. But I also think from the standpoint of patient-centric decision-making and patient involvement in care, the OTC availability of some drugs is a very reasonable option.

Next: "Self-selection is one of three cardinal aspects of the OTC switch process"

Let’s focus on urology. An OTC drug has to be safe, effective, and treat a condition that the patient can recognize and manage without the supervision of a licensed health care provider. What urologic conditions lend themselves to these parameters?

The one that we have the most recent experience with is overactive bladder, which is a symptom syndrome that involves urgency frequency and urge incontinence, which are patient-perceived symptoms. We put a lot of regulatory constraints on how we measure that condition when we do trials that result in regulatory approval for prescription branding. But for OTC, those controls are different and then the decision to take a drug defers to the patient to make a decision based upon their symptoms.

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You allude to something that’s a key part of the OTC process, which is the ability to appropriately self-select. Self-selection is one of three cardinal aspects of the OTC switch process and one that essentially gets at the patient’s level of comprehension of symptoms but also their level of medical literacy. Medical health literacy is something that I’ve been very interested in the last several years, mainly as a way to improve informed consent around risks/benefits and potential options.

What we deal with in pelvic medicine are very complicated conditions. Self-selection is a critical aspect of the success and safety of the OTC switch, and there are controls and algorithms in place to not only assess patient literacy but also to assess the individual’s ability to appropriately self-select based upon the labeling of the drug.

The other aspects of the switch process include the ability to understand the label (label comprehension), and lastly, stop or do not use criteria (centering on co-morbidities and other issues that could result in delayed diagnosis that may put the individual at risk).

Let’s discuss the large overactive bladder market. Are there any OTC drugs for overactive bladder currently available in the U.S.?

No. Transdermal oxybutynin, marketed as Oxytrol for Women when it was switched to an OTC drug, is no longer available. OTC Oxytrol for Women was removed from the market because it was not a commercial success. Rightfully so, there were constraints regarding hematuria and how that should be assessed and recurrent urinary tract infections and how that should be assessed, and it became a relatively complicated process.

Despite the efforts of a very experienced group of people who had done multiple OTC switches very successfully in the past and knew the process, the commercial failure was probably due to the complexity of self-selection and also due to the fact that the drug had a just-above-placebo effect and patients probably didn’t perceive enough benefit to stay with it.

I was very much involved in the clinical trials for the regulatory approval of the prescription version of Oxytrol. Statistically, the transdermal delivery system worked. Patients had less dry mouth than those taking the oral formulation, and they separated from placebo. But one of the interesting phenomena that we deal with in functional medicine is that statistical superiority does not necessarily imply clinically meaningful benefit for individuals. This is the conundrum of clinical trials.

Should we be concerned about Brody and Light’s inverse benefit law stating that, as a drug is promoted for milder cases of a disorder or used for unapproved conditions, which can happen in the OTC market, the benefit/harm ratio worsens because effectiveness is diluted but the risks of harm are the same?

That brings up a very interesting part of the OTC process as far as I’m concerned, which is the labeling. Labeling is supposed to inform the individual when to use, when not to use, when to contact a physician, and what aspects of their particular presenting scenario should or shouldn’t be considered for the drug. But, again, you’re giving the individual consumer a box that has labeling at a sixth-grade reading level that they should intellectualize and understand.

Ultimately, you’re giving them the decision about whether or not they should use it in an unapproved circumstance. It comes down to that decision.

One of the other important aspects of OTC switches is the actual-use study, where the compound, although it has been very well studied, is put in various public domains, such as pharmacies or malls. Patients are asked to come back after a 2-week time frame and asked if they used the drug appropriately and, if not, why not?

Overactive bladder is a tricky condition. You can get urgency and frequency associated with urinary tract infection. You can get urgency and frequency associated with dietary ingestion of some liquids and food stuffs in some patients. There probably was some blunting of effect because of dispersal in the general population.

When I look at other available OTC products that are used by patients with overactive bladder, the best are the azo-based products, such as Azo-Gantrisin. Patients take those frequently for urgency/frequency and obviously they have a urinary tract suppression indication, not urgency/frequency.

When I worked at the FDA in 1999, terazosin was considered for an OTC switch for outlet obstruction and it went nowhere. What about the more selective alpha-blockers that are off patent now?

The concern with alpha-blockers is the potential for either postural blood pressure changes and/or hypotensive effects, which are very limited but still in the label, even of the very selective alpha-blockers. Another concern in the general population that may not have been as adequately screened as clinical trial populations relates to patients with more marginal cardiac or vascular status. If one of these drugs enters the OTC world, there is a risk of exacerbation of syncopal episodes and other concerns associated with it, even though these agents are super selective.

Tamsulosin is probably the closest of these agents to being considered for OTC status. Again, however, from our clinical results with tamsulosin, we know that some patients may have postural hypotension or at least near-syncopal episodes that may or may not be due to hypotension. Ejaculatory dysfunction is also a concern, but is less of a threat.

Are 5-alpha-reductase inhibitors good candidates for OTC?

The overall side effects are relatively low with 5-alpha-reductase inhibitors. Obviously, the more prominent ones are the sexual side effects. There are some issues with fluid retention associated with them. Also, they’re not the most pleasant drugs to take. The potential for onset of gynecomastia associated with them can be very embarrassing. Although those effects are not life or limb threatening, they are not exactly things that people are happy to encounter.

Next: What are the potential roadblocks to OTC status for PDE-5 inhibitors?

The big elephant in the room is the fact that the PDE-5 inhibitors have either come off patient or will be shortly. What is their status and what are the potential roadblocks to OTC status?

The PDE-5 inhibitors all remain prescription drugs. Generic versions of Viagra are being launched. We all know that PDE-5 inhibitors have some potential side effects-visual and auditory side effects-that occur in a very small percentage of patients but could be problematic if exposed to the general population. The real question concerns the stochastic use associated with erectile dysfunction versus a continual daily dose of Cialis, for instance, which is approved for daily-dose use for voiding dysfunction as well as erectile dysfunction.

What steps do you take to avoid surgical complications?

We understand the mechanistics of the PDE-5 inhibitors for causing vasodilation, but if you functionally look at how they work, patients subjectively are better but there is no urodynamic correlate to that. Yes, there’s a slight improvement in flow rate, but you see no change in bladder contraction capabilities or bladder emptying. Some very interesting work done recently suggests that the PDE-5 effect, which can be a very significant subjective effect for some individuals, actually results from a spinal cord reflex mechanism (at least in rodents.)

Is there a possibility that they could be pushed for OTC use? Sure. The public certainly is aware of the class and certain agents in the class, and I think the public has had a recently positive experience with the PDE-5 inhibitors. But, again, because of the lack of true understanding of effect and the potential for both visual and auditory concerns, I think it’s going to be a bit of a safety hurdle.

There’s certainly been a lot of education directed to the public, but what about the nitrate issue?

The cardiac issue and the use of these drugs with nitrates is a substantial issue, and I think even experienced patients have trouble understanding that. So there will be a very significant self-selection concern.

Zithromax is available over the counter in the UK and Hiprex is available over the counter in Denmark. Do you see urinary antiseptics or antibiotics for UTI ever going OTC in the U.S.?

I say this self-ashamedly as a urologist, but we haven’t done a good job with institutionalizing treatment for urinary tract infections. A whole generation of physicians coming out of medical school don’t even understand the basics of urinary tract infection. We see a lot of overuse and abuse of antibiotics. We’re in a time of increasing antibiotic stewardship because of concerns related to antibiotic side effects. I personally have encountered quinolone-induced bacterial overgrowth, colonic bacterial overgrowth, and the sequelae of that.

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The antiseptics and acidic agents such as methanamine hippurate may potentially provide a benefit for individuals who are prone to recurrent infections and are trying to self-medicate. The issue with methanamine hippurate concerns renal function and patients’ understanding of that. There are many people who don’t understand how bad the effect on renal functions is, and I think that’s critical.

Next: "To put an anabolic steroid or an agent that has anabolic steroid-like effects in the OTC world would, in my opinion, be a significant risk for patients"

Are there any herbal remedies like saw palmetto or testosterone-like substances that you feel should not be freely available?

Herbal remedies are available and used frequently by patients for urinary tract consideration. The most recent “herbal supplements” getting some play have been the cranberry extracts. Patients ingest them maximally.

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I’ve served on the FDA advisory panels related to testosterone use, and I have grave concern about products that have anabolic effects and the general public’s relative lack of appreciation of those negative effects. Unfortunately, anabolic steroids have received a lot of positive play from the body building community and there’s been a fair amount of promotion of anabolic steroids for male health issues and male andropause.

To put an anabolic steroid or an agent that has anabolic steroid-like effects in the OTC world would, in my opinion, be a significant risk for patients in terms of the downstream effects on the blood, liver, and cardiovascular system.

“Behind the counter” is not a standard classification for drugs in the U.S. but is a category in Canada and the UK. Do you think that in some gray areas, there would be a place for behind-the-counter drugs empowering the pharmacist for some urology medications in the U.S.?

I think that’s coming as we see greater involvement of pharmacists in ambulatory care. We’re seeing that with the advent of the various clinics in the larger pharmacy chains, and more importantly, the empowerment of pharmacists to actually go out from behind the counter and advise and help patients make selections. I think it’s a natural outgrowth of the expansion of registered pharmacists and their perceived role.

Could it be done in a way that’s safe and reasonable? Yes, I think it could be. In essence, we’re already doing that with some of the decongestant medications because of concerns not so much about the medication for individual use but the use of the medication for illicit purposes.

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Switching a medication from prescription to over-the-counter status comes with challenges and risks, and is not always successful. In this interview, Roger Dmochowski, MD, discusses the pros and cons of OTC medications and explains the hurdles facing potential OTC products for urologic conditions.

 discusses the need for urology-gynecology collaboration, the background behind the ABMS recognizing the female pelvic medicine and reconstructive surgery subspecialty, and how barriers to full integration of providers treating pelvic floor disorders can be overcome. Dr. McAchran is associate professor of urology with a dual appointment in the departments of urology and obstetrics and gynecology at the University of Wisconsin School of Medicine and Public Health, Madison. She is also medical director of Women’s Pelvic Wellness Clinic at the University of Wisconsin. She was interviewed by 

clinical professor of urology at Stanford University School of Medicine, Stanford, CA. 

In the past, there were tremendous turf battles between gynecology and urology. When one tried to impinge on the other’s territory, it was usually the dean who became involved. What do you think drove the change to cooperation we see now?

I think one of the main factors was each specialty realizing that neither one could completely “own” this set of clinical problems and that we need each other. Urology would need the OB/GYN expertise, and OB/GYN would need the urology expertise to make any progress in terms of research, patient care, and professional training.

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At my institution, Dr. Laurel Rice, chair of the OB/GYN department, and Dr. Stephen Y. Nakada, chair of the urology department, have created an atmosphere where we could move forward to create a collaborative rather than a competitive approach. It’s important to have the mindset from the administration that it’s better for everyone to collaborate. It’s better for our medical students, it’s better for our trainees, and it’s better for our patients if we have a collaborative rather than a competitive approach.

Pelvic floor disorders, including pelvic organ prolapse, urinary incontinence, and fecal incontinence, affect over 20% of adult women. In 2010, an estimated 560,000 women underwent surgical repair of pelvic organ prolapse or stress incontinence. The demand for services is increasing. Do you think this is one of the factors that pushed urology and urogynecology to collaborate?

Several factors are driving collaboration. I think that demand, the need for research-driven data, the need for patient quality outcomes, and patients themselves are driving collaboration. In the current market, patients view themselves as consumers. Our health care system views them as consumers. Patients are no longer going to be satisfied with trying to seek the answer to their multi-system problem from multiple places; they want easy-to-navigate care for these problems. That’s what we’re trying to do at the University of Wisconsin: create a one-stop shop where we come to the patient rather than sending the patient out to multiple places.

Next: Is there a need to increase the number of providers to meet demand?

Kirby has estimated that 3,735 pelvic floor disease specialists will be needed, or one per 100,000, in the next 15 years 

 That means adding 2,300 specialists given that in 2013 there were 1,400 members of the American Urogynecologic Society (AUGS). The prevalence of female pelvic disorders is expected to experience 45% growth in the next 20 years. Up to half of U.S. women experience one or more symptoms of pelvic floor disorders during their lives. One in nine will undergo surgery for female pelvic floor dysfunction by age 80. Do you think there’s a need to increase the number of providers-urogynecologists, female urologists, nurse practitioners-to meet this demand?

There’s clearly a need. The way we’re going to meet that is twofold: by increasing interest and increasing training opportunity. Increasing interest starts at the medical student level. When I was a second-year medical student at Vanderbilt, I went to a panel discussion on women in surgery and Dr. Jenny Franke, Vanderbilt’s female urology specialist at that time, was one of the speakers. I thought everything she said sounded incredibly interesting. So I focused on rotating through urology in my third year, working with Dr. Franke in my fourth year, and ultimately went into urology with the hopes of doing what I’m doing now.

At UW, we have a fourth-year rotation for the medical students in urogynecology that satisfies their surgical rotation. We have exposure to urogynecology in the OB/GYN rotation that is done during the third year. Increasing that exposure is really important. That continues on into residency training as well. All of the residents in urology and in OB/GYN have some exposure to female pelvic medicine and reconstructive surgery (FPMRS) at our institution.

In addition, for institutions that don’t have such a strong faculty presence in that, the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) runs the Resident Preceptorship program every August, which sponsors residents from all of the different urology programs in the country to come to Chicago for a “mini-fellowship” in female urology with specialists from across the country. That’s another way that we can generate interest in pursuing this as a career.

Can you discuss the history of the American Board of Medical Specialties recognizing the subspecialty of female pelvic medicine and reconstructive surgery?

As I understand it, SUFU and AUGS, which were the urology- and the OB/GYN-based subspecialty societies that were interested in this, wanted to make FPMRS a more formalized training program and so began accrediting postgraduate training programs in that around 1998. That means that the trainees have finished a fellowship but they are neither certified nor examined. To be certified and examined, you have to be recognized by the American Board of Medical Specialties (ABMS). It took until 2011 for that to happen. Once you’re recognized by the ABMS, your fellowships have to be accredited by the Accreditation Council for Graduate Medical Education, which is an entirely separate application process. That was completed in 2011 as well.

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In 2013, the first certified examination was given; that was a written examination. Both grandfathered and fellowship-completed examinees were allowed to take that exam. Going forward, only those applicants who have completed an accredited fellowship may sit for the exam.

Next: What do you see as barriers to full integration of all physicians involved with full-time care of patients with pelvic floor disorders?

What do you see as barriers to full integration of all physicians involved with full-time care of patients with pelvic floor disorders?

In 2000, Dr. Jerry Blaivas wrote an editorial called “Herding cats” that covered this exact issue 

 The two big barriers he identified were territory and money. While these are not as problematic today as they were then, they are still problems going forward.

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Territory is difficult because you have to navigate the waters between the generalist and the specialist within urology and within GYN and then navigate between urology and GYN. If there’s limited territory, that can be challenging. But as we discussed earlier, the territory is really expanding in this field. There are lots of patients with these problems.

Dr. Blaivas thought the money problem could be solved by having us work together and share income the way we do within our individual departments now. That would be the ideal way for that to happen, but in an academic medical center, where funds flow along departmental lines, that’s challenging. It’s challenging to figure out how providers are going to be reimbursed, how physicians will be compensated, and how to gather resources, space, and staff.

There are also practical barriers. How do we take call for each other? If I’m a urology practice and I want to expand my FPMRS services by hiring a gynecologist who has finished an accredited training program, how do I fit that person into my call schedule?

How would the conversion of the volume-based model of financing U.S. health care into a value-based model in which quality indicators will lead the path for financial incentives benefit female pelvic medicine?

There are data from other diagnoses that have multi-system effects-multiple sclerosis, spina bifida, obesity, and diabetes-demonstrating that a multidisciplinary approach to those problems is beneficial in terms of quality outcomes. Pelvic floor disorders certainly apply to that. I think that female pelvic organ reconstructive surgery is well poised to do this because the goal of such collaborations as the Pelvic Floor Disorders Network and the Urinary Incontinence Treatment Network was to work together to develop large, prospective data-driven answers to some of the key questions. Because we have a history of doing that, we’re going to be well poised to figure out the quality indicators for our specialty going forward.

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UW is one of the pioneer sites for the AUGS Pelvic Floor Disorders Registry, which is a multicenter, prospective cohort study looking at surgical versus medical treatment of patients with pelvic organ prolapse. It examines effectiveness, quality of life, and safety of therapy. I wouldn’t be able to participate in that if I wasn’t in a multidisciplinary program. Having that collaborative approach really helps.

A multidisciplinary program seems like a great fit if you’re going to pay based on quality rather than volume; the multidisciplinary group would squeeze out providers who are not in the group because their quality is going to be so much higher.

Absolutely. In the study from Kirby that you mentioned, while demand for care increased over the time covered by the study, the number of surgeries actually didn’t increase commensurate with that, which I think goes to show that surgery is not always the quality answer. In a volume-based model, surgery is always the answer.

Next: "To have an FPMRS service line, first and foremost you have to have the human capital."

How does the new generation of fellowship-trained urologists and gynecologists who are trained in cross-disciplinary programs in which the message of collaboration and integration is increasingly advocated serve as a positive force to help institutions fully integrate the FPMRS service line?

To have an FPMRS service line, first and foremost you have to have the human capital. You have to have physicians who want to work in that type of situation and who understand the benefits of working in that type of situation; if you don’t, you can’t get anywhere. Having trainees come out of programs where they’ve been exposed to that is incredibly beneficial. My fellowship training was at Cleveland Clinic, where we had multidisciplinary conferences and research, and we served on each other’s services throughout the training. I absolutely understood the benefit of that, and it has always been my goal at UW to create a similar environment. All of my partners in urogynecology came from similar backgrounds. That really helps.

Where do we stand now with integration and training, and what benefits have become apparent? Is there a geographic difference in harmonization?

There are 56 fellowships that are accredited, and by my estimation about 32 of them accept both urology and gynecology backgrounds in the fellowship program. I think integration is there and I think it’s hard-wired going forward. To be an accredited fellowship, you have to have a urologist and a gynecologist background as part of your program. Exposure to that is part of your training.

One of the very specific benefits I can talk about in our multidisciplinary program is increased patient compliance. We compared compliance with prescribed pelvic floor physical therapy in patients who were seen in our multidisciplinary clinic by both a physician and a pelvic floor therapist with patients who were prescribed that treatment option from a physician-only clinic. We found that compliance was much better with patients seen at the multidisciplinary clinic.

I don’t know that there are geographic differences. The real issues are resources and commitment, the human capital. Those are the barriers to this getting fulfilled.

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In this interview, Sarah E. McAchran, MD, discusses the need for urology-gynecology collaboration, the background behind the ABMS recognizing the female pelvic medicine and reconstructive surgery subspecialty, and how barriers to full integration of providers treating pelvic floor disorders can be overcome.

Urology, gynecology collaboration addresses rising demand

	While a number of medical and non-medical therapies are available to treat overactive bladder, underactive bladder, bladder outlet obstruction, and bladder pain syndrome, the search continues for therapeutic options that raise the bar of efficacy and safety. In this interview, 

 discusses current treatments for these common voiding dysfunctions and future directions, including central nervous system agents and combination therapies. Dr. Andersson is professor of urology at Wake Forest School of Medicine, Winston-Salem, NC. He is also a Jens Christian Skou fellow at Aarhus University, Aarhus, Denmark. Dr. Andersson was interviewed by 

 professor of urology at the University of Pennsylvania, Philadelphia. 

I’d like to discuss the management of several common voiding dysfunctions, starting with overactive bladder. What is the current state of therapy using oral medications, and how can we expect our oral therapy options to change in the future?   

	The current first-line therapies are various antimuscarinic drugs and the beta-3 receptor agonist mirabegron (Myrbetriq). There may be changes in the proportion of people treated first with antimuscarinic drugs or the beta-3 agonist, but for the next 5 years at least, these two drug classes will be first-line pharmacologic therapy. There are possibilities to treat those who do not respond to these two types of treatment with botulinum toxin (Botox).

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	If we look at what’s in the pipeline, there are very few new drug principles. There are a couple of new antimuscarinic drugs in development, but they don’t appear to have any specific properties that would make them better than the ones we have. Since we have such a low number of established and accepted drugs, I think we have to use combinations. One of the combinations in the pipeline is the antimuscarinic solifenacin succinate (VESIcare) plus mirabegron, which is currently in phase III trials. We will likely see that drug combination on the market within the next few years.

Next: "Looking outside what is recommended by the regulatory authorities, a lot of drugs are used to treat OAB." 

	Looking outside what is recommended by the regulatory authorities, a lot of drugs are used to treat OAB. I know some clinicians use imipramine (Tofranil), and I don’t think this is a good way to treat patients because of the risk of cardiac arrhythmias. Other drugs, particularly those working on the central nervous system, have shown efficacy, but the efficacy has not been better than that obtained with antimuscarinics and mirabegron. In the near term at least, I don’t think we will have any drug acting on the central nervous system that can be developed into useful therapy. Unless a drug shows better efficacy and better tolerability than what’s currently available, drug developers are unlikely to back it financially.

Do you see new ways to deliver botulinum toxin, other than intradetrusor injection?

	We have the liposome-coated botulinum toxin that can be instilled into the bladder, and this was examined in a small phase II study of 24 patients. In this controlled study, 12 of the patients were treated with botulinum toxin, and 50% of them responded quite well in terms of urgency and frequency. If you look at this as a proof-of-principle study, it might work.

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	There are other developments that involve modifying the botulinum toxin molecule. The active ingredient in botulinum toxin is an enzyme that inactivates the mechanism that releases nerve transmitters. You can attach to the enzyme a component that directs the molecule to a specific site and another component that enhances penetration. This is not only an interesting principle for overactive bladder, but we may be able to use it in pain treatment as well. It would be interesting to see if this actually works in interstitial cystitis patients, for example.

	I think this is a novelty that has potential to develop into something new. If you can document botulinum toxin as an instillation as an effective form of treatment with a lasting effect of 6 to 9 months similar to that observed with injection therapy, it may be an agent we can start in patients earlier, rather than first trying another antimuscarinic, then two antimuscarinics or mirabegron.

You’re saying there might be a way to change the molecule itself to make it usable as an intravesical instillation.

Next: Percutaneous tibial nerve stimulation

Percutaneous tibial nerve stimulation has had surprising efficacy as a less-expensive, noninvasive way to deliver neuromodulation. Do you see these units being applied percutaneously in shoes or boots?

	I think there is a very good preclinical rationale for that. It has been worked out at the University of Pittsburgh that this type of stimulation in combination with drugs may be very promising. Percutaneous nerve stimulation by itself has efficacy comparable to that of the best antimuscarinics.

	If you could combine an established drug with transcutaneous nerve stimulation, you may actually increase efficacy because the treatments are based on two different principles. For example, opioids such as tramadol (Ultram) used in low doses have been shown to work very well in cats. Tramadol is as efficacious as any antimuscarinic. There is a controlled clinical study showing that, but we can’t recommend tramadol because of the side effects. The principle of using a low-dose opioid is intriguing, however, because there is no more effective way of stopping bladder contractions than with opioids.

Next: Realistically, can a drug be designed to effectively treat underactive bladder?

Let’s turn to underactive bladder. There’s no really effective pharmacotherapy for underactive bladder, although muscarinic receptor agonists, anticholinesterase inhibitors, and alpha-adrenergic receptor antagonists have been used with limited success. Realistically, can a drug be designed to effectively treat underactive bladder?

	If you mean that one drug could solve the problem, I would say no because underactive bladder has so many different etiologies. However, if we could define the underlying causes, there are many potential targets for drugs that might offer improvement.

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	I don’t think the drugs you mentioned can be applied with any success. For example, the mechanism of a muscarinic receptor agonist is to cause a contracture of the muscle. It contracts the bladder if the bladder is able to contract. I don’t think it’s useful, and it’s painful. If you inject patients with carbachol, which we did many years ago, the result is a painful bladder contraction. We could increase intravesical pressure, but patients couldn’t void better.

	A new agent that is in phase I trials, meaning it has passed the tolerability level, is a prostanoid EP2 and EP3 receptor agonist. In presentations at the 2015 AUA annual meeting, this agent was observed to have a very nice effect in a monkey model of underactivity. It was shown to contract the bladder and relax the urethra, which is theoretically what we would like to see. I seriously doubt that it works in all cases of underactive bladder, but at least it is a step in the right direction.

Next: "A presentation at the 2015 AUA annual meeting showed that there can be a progression from overactivity to underactivity."

Dr. Mike Chancellor has hypothesized that underactive bladder and overactive bladder may not be entirely separate disease entities. Instead, chronic untreated or treatment-refractory overactive bladder due to neurologic diseases such as diabetes or bladder outlet obstruction, or aging, sarcopenia, and frailty may progress to detrusor hyperactivity with impaired contractility and finally underactive bladder. Do you think there’s a continuum there?

	A presentation at the 2015 AUA annual meeting showed that there can be a progression from overactivity to underactivity. This has been shown in an animal model of ischemia. Many of the disorders you mentioned may have bladder ischemia contributing to the lower urinary tract dysfunction. Ischemia initially causes overactivity and if the ischemia continues, the result is bladder underactivity. Chronic bladder ischemia most probably hits not only the detrusor muscle with the deposition of collagen, increased stiffness, and reduced compliance, but also causes reduced sensation because you lose nerves. Thus, progressive bladder ischemia may lead to a combination of detrusor hyperactivity with impaired contractility (DHIC), which was the original term for this condition.

Expression of vitamin D3 receptors (VDRs) is present in the human urethra, prostate, and bladder. Decreased cell proliferation and induction of apoptosis in the prostate have been achieved with elocalcitol, which is a VDR agonist. Can you comment on this?

Can a patient’s foot help their OAB symptoms?

	It’s not as simple as this agent being a vitamin D agonist; it’s also a Rho-kinase inhibitor. Some early clinical observations have shown it could be used in overactive bladder, and there are good pre-clinical data showing it may be efficacious. Unfortunately, the drug company developing it has closed, and there are no new developments in this area. I do think that Rho-kinase inhibitors in general may offer an interesting possibility for improving patients who have, for example, outflow obstruction.

Next: "There are many possibilities for treating [outlet obstruction] pharmacologically."

In general, do you think we’ve hit a barrier in the treatment of outlet obstruction, or do you see potential new advances?

	There are many possibilities for treating it pharmacologically. Standard therapy is, of course, alpha-blockers and 5-alpha-reductase inhibitors. There are also combinations, using alpha-blockers and antimuscarinics, in patients with storage symptoms. If a patient has bladder outlet obstruction and has a big prostate, the rational first step is to remove the prostate. However, there are many patients who have storage symptoms after removal of the prostate; up to 30% will still have overactive bladder.

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	In such a case, I think we’re talking about two separate disorders. Outflow obstruction can lead to both voiding and storage symptoms, but at the age people experience these symptoms, they also get OAB that may be independent of the outflow obstruction.

Looking at all these conditions, I’m hopeful that we may have the greatest chance of a breakthrough in bladder pain syndrome, which has multiple targets-frequency, pain, and urgency. Do you think that they are so interrelated that we can’t see them as individual targets or do you see opportunity here?

	I see opportunities. I also recognize that there are two types of patients with bladder pain syndrome: those with Hunner’s lesions and those without Hunner’s lesions. These types could be separate diseases. But I don’t think we’ve completely ruled out that some bladder pain syndrome patients with no morphologic changes in the bladder actually show progression and develop Hunner’s lesions. It may start as a bladder pain syndrome, and a small fraction of patients then show progression.

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	Concerning treatment, of course you can’t have sensation of pain from the bladder without activating afferents. That makes bladder afferents a very attractive target. There are many ways of affecting afferents and release of inflammatory mediators. A universally effective drug to treat bladder pain syndrome simply doesn’t exist. That’s why we have to individualize treatment and find some kind of drug combination that could help the patient. I don’t know to what extent distention therapy and instillations are helpful in general. There are some patients who respond to any type of treatment.

In this interview, Karl-Erik Andersson, MD, PhD, discusses current treatments for common voiding dysfunctions and future directions, including central nervous system agents and combination therapies.

Philip M. Hanno, MD, MPH

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