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The Journal that never sleeps

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Thank you all for your overwhelming support of the new web and paper versions of the BJUI. For those who have missed it, please check out the web journal at: www.bjui.org.

We hope you had a relaxing holiday period – we certainly did and recharged our batteries. Despite this, the editorial team at the BJUI handled 76 articles between Christmas 2012 and New Year’s Day 2013; an average of 10 per day.

This is a reflection of the global popularity of the BJUI. We have papers coming in from all over the world from many different time zones. Furthermore, New Year celebrations in the West do not necessarily match others, such as the Chinese New Year or the Baisakhi in the Northern Indian subcontinent. The BJUI wants to continue receiving the best papers from our authors irrespective of where they are on this planet.

As a celebration of our truly global presence we are delighted to present content from around the world at www.bjui.org as articles, blogs and videos, and we invite you to post your comments on any or all of these.

The BJUI poll shows that our readers love the ‘article of the week’, which is available completely free to everyone, everywhere.

In this issue we highlight the role of tadalafil, not just in erectile dysfunction but also in ejaculatory and orgasmic dysfunction. This article provides Level 1 evidence and is accompanied by an editorial from Mike Wyllie, our expert in Sexual Medicine.

Please keep the conversations going on Twitter, Facebook and Blogs@BJUI. Your web journal needs you.

Prokar Dasgupta, Editor-in-Chief

Ashutosh Tewari, Editorial Board

Video of Ashutosh Tewari reading the Journal in New York

Editorial: Oncological outcomes: open vs robotic prostatectomy

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John W. Davis and Prokar Dasgupta*

Departments of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA and *Guy’s Hospital, Kings College London, London, UK
e-mail: [email protected]

For men at significant risk of dying from untreated prostate cancer within reasonably estimated remaining life spans, which technique offers the best disease-free survival: open radical prostatectomy (RP) or robot-assisted RP (RARP)? The practice patterns in many countries suggest RARP, but many concerns have been raised about the RARP technique for high-risk disease, including positive surgical margin rates, adequate lymph node dissections (LNDs), and the learning curve. In this issue of the BJUI, Silberstein et al provide a convincing study, short of a randomised trial, that suggests that in experienced hands both techniques can be effective, and that surgeon experience had a stronger effect than technique. In contrast to large population-based studies, this study sought to take the learning curve and low-volume surgeon variables out of the equation by restricting the inclusion criteria to four high-volume surgeons from a single centre. The follow-up is short (one year), and may underestimate the true biochemical relapse rates, and needs follow-up study, but for now offers no difference in relapse rates nor pathological staging outcomes.

Beyond the comparative effectiveness research (CER), Silberstein et al also provide a valuable vision for prostate cancer surgeons using any standard technique. Several recent landmark studies on PSA screening, the Prostate cancer Intervention Versus Observation Trial (PIVOT), and comparisons of metastatic progression between RP and radiation, all indicate the need to shift our practice pattern towards active surveillance for lower risk patients (with or without adjunctive focal therapy, but the former still experimental in our view), and curative therapy for intermediate- to high-risk disease. Such a practice pattern is evident when you compare this study (2007–2010) with a similar effort from this institution (2003–2005) comparing RP with laparoscopic RP (LRP). In the former study, >55% had low-risk disease compared with <35% from the current study. As expected, the present study shows higher N1 stage (9%) and positive surgical margin rates (15%) than the former (7% and 11%, respectively). While erectile function recovery was not presented, the authors noted the familiar reality that patients demand nerve sparing whenever feasible, only 2% in this study had bilateral non-nervesparing and 91% had a combination of bilateral or partial nerve sparing. The number of LNs retrieved has increased from 12–13/case to 15–16, and the authors state that even with nomogram-based exclusion of mandatory pelvic LNDs with <2% risk of N1 staging, this modern cohort had a pelvic LND in 94% of cases, including external iliac, obturator, and hypogastric templates.

We fully concur with this practice pattern, and have recently provided a video-based illustration of how to learn the technique, and early experience showing an increase in median LN counts from eight to 16, and an increase in positive LNs from 7% to 18%. By risk group, our positive-LN rate was 3% for low risk, 9% for intermediate risk, and 39% for high risk. We certainly hope that future multi-institutional studies will no longer reflect what these authors found, in that RARP surgeons are five times more likely to omit pelvic LNDs than open, even for high-risk cancers.

Finally, Silberstein et al and related CER publications leave us the question, does each publication on CER in RP have to be comprehensive (i.e. oncological, functional, and morbidity) or can it focus on one question. Members of this authorship line have published the ‘trifecta’ (disease control, potency, and continence) and others the ‘pentafecta’ (the trifecta plus negative surgical margins and no complications). Indeed, Eastham and Scardino stated in an editorial that ‘data on cancer control, continence, or potency in isolation are not sufficient for decision making and that patients agreeing to RP should be informed of functional results in the context of cancer control’. We feel that the answer should be no, focused manuscripts have their merit and publication space/word limits create this reality. But we should not discount the sometimes surprising results when one institution using the same surgeons and methodologies publishes on the broader topic: the Touijer et al. paper discussed above found the same oncological equivalence between RP and LRP as this comparison of RP and RARP, but also included functional data showing significantly lower recovery of continence with LRP. Nevertheless, the recent body of work in the BJUI now provides a well-rounded picture of modern CER including oncological outcomes, complications, recovery of erectile dysfunction, continence and costs. We feel it is reasonable to conclude that patients should be counselled that RARP has potential benefits in terms of blood loss, hospital stay, and complications (at increased costs), but oncological and functional results are probably based upon surgeon experience.

Abbreviations

CER, comparative effectiveness research; LN(D), lymph node dissection; (RA)(L)RP, (robot-assisted) (laparoscopic) radical prostatectomy

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Through My Father’s Eyes

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Growing up with a father who was a general surgeon, now retired, I was frequently exposed to the life and practice of a doctor. I witnessed a caring, compassionate physician rush off in the middle of the night to take out an appendix or manage a local trauma or an acute abdomen. What I was also witnessing was traditional and now, almost historic, medicine at its finest. The days of constant call, pay-for-service, and the prestige of medicine were in their hayday.

Since then, the transition to this current era has been dramatic. We’ve seen the evolution of evidence-based medicine, and more active involvement by the government within the practice of medicine, including governmental acts in healthcare laws to both protect patient’s privacy and to expand medical coverage for all. We’ve seen the reduction in residents’ hours leading to expectations of new practicing physicians to want to work less (and get paid more!). We are seeing hospitals purchasing practices by and the painful extinction of the private practitioner. There are more practice requirements, as well as restrictions, from both regulators and specialty societies. Accompanying this change has been the evolution and revolution of medical science that is slowly changing from what used to be significantly experiential and anecdotal to a more data-driven knowledge base in the formation of guidelines and best practice statements. This is going even further to include quality measurements that will not only improve outcomes but influence payment models and reimbursements. Additionally, the maturation of the Internet allows instant access to information: from being able to access everything from your pocket smart phone to the expansion of social media exemplified by the efforts of BJUI herein and the recent journal clubs conducted entirely on Twitter; technologies tying specialists together from all over the world.

Medicine has never just been about helping people, it is really about change: learning new science whether it be pathophysiology, medications or techniques. The ability for the practitioner to acclimatize to that change is how medicine has weathered the test of time. We adapt, we learn, and, ideally, we grow and become better doctors providing better care.

I recently had the pleasure of introducing my son, a high school student, to surgery just as my father had done with me (my first case was an appendectomy): he was able to observe a PCNL. Previously, if asked, he had disavowed any concept of pursuing medicine. Now, after seeing “cool” surgery that was like playing a video game, he is reconsidering. If he does enter into it, what will medicine look like in his time? How many more changes will occur going forward? How will we continue to evolve? Will he one day reflect upon medicine as it was through his father’s eyes? Time will tell…

 

Timothy D. Averch, MD, FACS is Professor and Vice Chair for Quality and Director of Endourology at the University of Pittsburgh Medical Centre Department of Urology, Pittsburgh, USA.

 

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BJUI at USICON

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BJUI had a very successful meeting at USICON in Pune. The hospitality was superb and a very well organised meeting. BJUI was represented by myself as Chairman of the Executive and by Prof Prokar Dasgupta as our new Editor. Prokar and his USICON counterparts put on a superb three hour symposium on how to organise a research project for publication. This symposium was extremely well attended with a vigorous interaction with the audience – it was very lively. In addition, Prokar had a significant input into a symposium on robotic prostatectomy as well as other scientific areas. Clearly, USICON were very pleased to see such an input into the USI from the BJUI and our attendance seemed to re-invigorate the relationship.

David Quinlan is Chairman of the BJU International Charity; Consultant Urologist at St Vincent’s University Hospital, Dublin; Senior Lecturer in Surgery at University College, Dublin, Ireland.

BJUI Editor-in-Chief Prokar Dasgupta with Drs Rane, Kochikar and Patel at USICON

 

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Editorial: Phosphodiesterase Inhibitors (PDEi) improve orgasm. The power of meta-analysis?

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Ever since the potential utility of meta-analyses in the assessment of clinical data was brought to the notice of the urological community by Peter Boyle [1], they have been used increasingly. Indeed this approach to evaluation of drug effects has become de rigueur for healthcare providers and regulatory bodies. In particular, invaluable insight has been given into the benefit : risk ratios of drugs in BPH/LUTS and overactive bladder. Even to the extent, where sufficiently large databases have been made available, it has been possible to identify characteristics predictive of subpopulations of responders and non-responders [1].

The most recent example of the power of meta-analysis is the rigorous statistical dissection of the impact tadalafil on sexual function in erectile dysfunction (ED) by the Department of Urology atWeill Cornell published in BJUI [2]. As would be anticipated from previously published individual clinical trials, there was confirmation in this review of 3581 subjects in 17 placebo-controlled studies, of the positive effect of tadalafil (exemplifying the phosphodiesterase inhibitor [PDEi] class) on erectile function. It could perhaps be argued that with a clinical effect as large and clear-cut as that of PDEi in ED, the meta-analysis was superfluous. Only in situations where the clinical impact beyond that of placebo was of lower magnitude does it come to the fore, e.g. a-adrenoceptor antagonists in the treatment of LUTS [3]. However, at this point the following health warning should be issued, PDEi in the hands of the skilled meta-analysts and marketeers: caveat lector (let the reader beware).
Returning, however, to the material in hand, the analysis of the tadalafil data also shows unequivocally that there is an additional positive effect of the drug (and presumably the PDEi class) on orgasm and sexual satisfaction. These products and class attributes have often been alluded to with varying degrees of conviction, but this is the first time convincing evidence has been tabulated and documented.

Also described is the positive effect of tadalafil on co-morbid ejaculatory dysfunction (EjD) which, at first sight, would tend to provide supportive evidence for the off-label use of tadalafil and other PDEi in the treatment of premature ejaculation (PE). Although the words in the manuscript [3] fall short of advocating this practice, the inference is there for all to read and potentially be detailed astutely by the field-force.We now move into the ‘grey’ area between caveat lector and caveat emptor (let the buyer beware). EjD can mean different things to different men and can represent a continuum from premature to delayed or even anejaculation. Almost certainly most of the patients in the clinical trials analysed would not meet the definition of PE crafted by the International Society for Sexual Medicine (ISSM) [4], so little conclusion about the benefit to men with PE can be drawn.

Ironically, a meta-analysis on the impact of PDEi on men with unequivocal PE (or at least meet the ISSM definition) has just been published [5]. The conclusion was that there is no clinically or statistically significant improvement in PE with acute or chronic treatment with PDEi.

Although, at least in the case of ejaculatory function the conclusion of the two meta-analyses appear to be at variance, in actuality they are addressing different questions. It remains, that, although in the use of meta-analysis we have the means of creating a level playing field, we have to be careful to consider what questions are being asked, by whomand with what objective.

References
1 Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology 1996; 48: 398–405
2 Paduch DA, Bolyakov A, Polzer PK, Watts SD. Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies. BJU Int 2013; 111: 333–42
3 Boyle P, Robertson C, Manski R, Padley RJ, Roehrborn CG. Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia. Urology 2001; 58: 717–22
4 McMahon CG, Althof S, Waldinger MD et al. International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int 2008; 102: 338–50
5 Asimakopoulos AD, Miano R, Agrò EF, Vespasiani G, Spera E. Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? A systematic review and meta-analysis. J Sex Med 2012; 9: 2404–16

Mike Wyllie
Plethora Solutions Ltd London, London, UK.
e-mail: [email protected]

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Urologist as the Go-to Adrenal Surgeon?

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What do Galen, da Vinci, and Vesalius have in common? All three, in all their detailed description of human anatomy, failed to note the existence of the adrenal glands. In fact, it was Bartholomeus Eustachius (yes, the one of the “tube”) who in 1563 was the first to document the glands’ existence. Meanwhile, it took another three centuries for Thomas Addison to recognize the physiologic importance of the adrenals. Soon thereafter, Charles Brown-Sequard, who appears to have toyed not only with spinal cords, removed both adrenals from a dog, thus proving that the glands were critical to life.

Notwithstanding the adrenals being a source of major human ailments, the glands and their pathology to this day often remain unnoticed. For instance, a study in the Harvard Vanguard healthcare system revealed that >80% of adrenal lesions do not receive adequate evaluation. Meanwhile, nearly 20% of adrenal incidentalomas potentially represent surgical lesions. Indeed, perhaps due to their understated anatomic prominence or more likely due to the embryologic origins that are distinct from the urinary or gastrointestinal tracts, the adrenal glands largely remain “orphans” in the surgical arena. Yes urologists, surgical oncologists, and more recently subspecialists known as endocrine surgeons manage and operate on the adrenal glands; nevertheless, referral patterns and expertise vary, and, arguably, no surgical specialty has consistently “parented” these organs.

In this lies a great opportunity.  Today’s urologists are ideally positioned to take the reigns on the surgical management of the adrenals. With the urologist’s advanced minimally invasive surgical skills, comfort with both retroperitoneal anatomy and surgical approaches to retroperitoneal organs, it is only natural that the evaluation and surgical management of adrenal disorders evolve and remain in the domain of urologic surgeons.

Nevertheless, a technical skillset in removing an adrenal should not be mistaken for adequate expertise in management of its pathology. In order for urologists to position ourselves as surgical leaders in the adrenal space, fluent knowledge of adrenal pathophysiology and appropriate evaluation is paramount. Nevertheless, “know-how” of adrenal management is infrequently mastered during urologic training. In my experience, many trainees and practicing urologists are somewhat overwhelmed by the complexity of adrenal pathophysiology and are often unsure how to distill the large volume of information they’ve learned for standardized examinations into practical knowledge. For instance, expertise on how to appropriately evaluate a referral for a newly diagnosed adrenal lesion is often lacking. Such lack of expertise potentially leads to overtreatment of some patients and undertreatment of others.

As the field moves forward, we must better educate our trainees and practicing urologists on the practical nuances of surgical management of the adrenals. The AUA Core Curriculum effort is a great start. However, a brief course at the AUA and/or EUA for practicing urologists is urgently needed.

As such, the close anatomic and physiologic relationship of the adrenals to the kidney positions urologists as the most appropriate surgical specialists for treatment of surgical adrenal disorders. However, leadership in the surgical adrenal space must be founded not only on technical skills, but also on clinical fluency in appropriately evaluating, selecting, and medically managing patients with adrenal neoplasms and disease. Tremendous opportunities on bridging the knowledge gap in management of surgical adrenal disorders exist and, potentially, can be solved by formal courses at national meetings.

 

Dr Alexander Kutikov, MD is an Associate Professor of Urologic Oncology at Fox Chase Cancer Center, Philadelphia, USA. @uretericbud

 

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What’s the diagnosis?

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Test yourself against our experts with our weekly quiz.

You can type your answers here if you want to compare with our answers, or just click the ‘submit’ button below.

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The Flaws of the PIVOT Study of Radical Prostatectomy versus Observation; Don’t Give up on PSA Just Yet.

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A recent editorial in the BMJ by Christopher Parker (Treating prostate cancer. BMJ 2012; 345: e5122) uses the “best available evidence” from the PIVOT study (Wilt TJ, et al) to argue the case for watchful waiting for low risk prostate cancer and question the need to diagnose the condition at all. Unfortunately the PIVOT trial was marred by a number of serious flaws that should make us doubt its conclusions.

The original design of the PIVOT trial included a randomisation of 2000 patients to surgery or observation (Prostate cancer, uncertainty and a way forward. NEJM 2012; 367: 270-1). Unfortunately, this goal was not achieved; the design was modified to justify a randomization goal of only 740 patients. Median survival was assumed to be 15 years in the original study design and 10 years in the updated version. If the median survival of 12 years in the study’s observation group is taken and 7 years for enrollment and 8 years of follow-up assumed, the sample requires 1200 patients in order to detect a 25% relative reduction in mortality with 90% power and a two-sided alpha level of 0.05. With an actual enrollment of only 731 patients, the study was consequently underpowered to detect this relatively large clinical effect. The wide 95% confidence interval around the hazard ratio for death in the treatment group illustrates this point. A relative increase of 8% to a relative reduction of 29% in the risk of death in the prostatectomy group, as compared with the observation group, cannot be excluded with 95% confidence. Only 15% of the deaths were attributed to prostate cancer or its treatment.

Although a “life expectancy of at least 10 years” was an entry criterion, by 10 years almost half the participants had died, leaving only 176 men in the surgery group and 187 in the observation cohort, and by 15 years only 30% were alive. The investigators therefore did not recruit healthy men who would be the normal candidates for surgery and randomize them to observation; instead they recruited elderly and co-morbid men with very limited life expectancy and randomised them to surgery (with one fatality!). Furthermore, the finding that one fifth of patients did not adhere to the assigned treatment further reduces the ability of the trial to discern a treatment effect.

Prostate cancer is a slowly progressive condition which eventually, and after many years, results in a painful death from metastases in a significant number of patients, unless mortality from other causes supervenes. Radical prostatectomy, now usually performed minimally invasively with robotic assistance (Goldstraw MA, et al), prevents disease progression in >80% of well-selected cases. We appear to manage localised prostate cancer in a much more holistic way than our American colleagues and MDT decision-making and robust active surveillance programmes have enhanced this. Others were also outraged by the Parker editorial and the intrinsically flawed results of the PIVOT study should definitely not encourage us to turn our backs on a disease that kills more than 10,000 men per annum in the UK and hundreds of thousands more worldwide.

 

Roger Kirby, Ben Challacombe and Prokar Dasgupta
The Prostate Centre, London W1G 8GT and Guy’s Hospital, King’s College London, King’s Health Partners

 

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BJUI and The Urology Foundation at 10 Downing Street

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Last night, I was delighted, along with other members of the BJUI Editorial Board, to attend a reception for The Urology Foundation at Number 10 Downing Street, hosted by the UK’s “First Lady” Samantha Cameron.

The reception was attended by many eminent urologists as well as a number of well-known personalities.

The primary aim of the reception was to raise awareness for the Foundation and its work and all of us at the BJUI are happy to help in that aim.

Prokar Dasgupta, Editor-in-chief

 

 

 

The Urology Foundation issued the following Press Release:

TUF Downing Street Reception hosted by Samantha Cameron

On Tuesday 22nd January 2013, Samantha Cameron kindly hosted a reception at No 10 Downing Street, for The Urology Foundation.

The Urology Foundation is the only UK charity that covers all urological diseases. It aims to improve the diagnosis, choice and care of patients with urological diseases by supporting pioneering research and providing specialist training to improve the skills and effectiveness of UK health professionals working in urology.

Around 120 dedicated supporters and friends gathered together in the Terracotta and Pillared Rooms, to celebrate The Foundation and the exceptional work it undertakes. Speeches were given by Samantha Cameron as well as the Hon Secretary of The Foundation, the esteemed Professor Roger Kirby, who announced an exciting new Bladder Cancer Awareness campaign for 2013.

Kindly showing their support were, amongst others, Ronnie Corbett CBE who is embarking upon a radio campaign for The Foundation, Private Eye editor Ian Hislop and actors, Jemma Redgrave, Vanessa Kirby and Douglas Booth.

 

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