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Editorial: Robotic simulation: are we ready to go?

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In a study in this issue of BJUI, Aghazadeh et al. [1] were able to show that there was a significant relationship between simulated robotic performance and robotic clinical performance. The authors conclude that this supports the implementation of such robotic training tools in a standardized robotic training curriculum. Evidently, particularly in minimally invasive surgery, we must assess and learn from our surgical errors in order to prevent them in future [2]. For this, the dream scenario would be the ability to simulate a surgical procedure before being allowed to perform the real operation on the patient, similarly to pilots being trained on a flight simulator [3]. A robotic (virtual) simulator would be the ideal way to provide training on the respective robot-assisted procedure [1].

The authors are to be congratulated in their effort to prove the transfer validity of their training model using 12 previously validated robotic skill tasks consisting of four inanimate models and eight selected virtual reality tasks on the da Vinci Skills Simulator [1]. Endopelvic fascial dissection during robot-assisted radical prostatectomy was chosen to assess clinical robotic performance. Trainees were evaluated using the Global Evaluative Assessment of Robotic Skills (GEARS) scoring system, which distinguishes among depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, robotic control in relationship to the case difficulty using scores ranging from 1 to 5.

Nevertheless, there is still a long way to go! The authors have already conceded that there are some limitations to their study. It involved a small cohort of urological surgeons of different levels of expertise. It was not a randomized study comparing the impact of virtual simulator training on the surgical outcome, therefore, the authors could only show that they might be able to predict a surgeon’s performance during a real case based on his/her performance at the simulator. Based on this, the simulator training could theoretically pre-assess surgeon’s quality in robot-assisted surgery.

The authors probably chose endopelvic dissection because it represents a relatively easy part of robot-assisted radical prostatectomy. Accordingly, it remains unclear whether such basic tasks are really the best models to prepare a surgeon for this operation. Using low-fidelity training models, including vesico-urethral anastomosis, we were able to demonstrate the transfer validity of a six-step training programme [4]. It would be interesting to see the impact of the simulator training on clinical performance of robot-assisted vesico-urethral anastomosis because a valuable exercise for this already exists on the da Vinci Skills Simulator.

Despite this progress, we must recognize that we are far away from equalling the simulator training of pilots [3]. It is much easier to simulate turbulence during a flight than significant bleeding during robot-assisted surgery. Trials in simulating a complete laparoscopic procedure are still in their infancy [5]. This may differ with regard to other minimally invasive procedures such as ureteroscopy, where sophisticated trainer exercises exist; however, even in this field there is actually no proven evidence of the significant impact of simulators on shortening the learning curve. For all ‘hands-on’ simulation there will be always the problem of soft-tissue engineering and navigation [6]. Robotic simulators have the advantage compared with laparoscopy of three-dimensional video technology and the fact that there is no tactile feedback for the surgeon.

Evidently, information technology is continuously advancing and we may one day have a robotic simulator that can compare with the flight simulators used in aviation; however, to date, only training on basic skills can be provided and evaluated using the existing simulation systems in urology.

Read the full article
Jens Rassweiler
Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heidelberg , Germany

 

1 Aghazadeh MA, Mercado MA, Pan MM, Miles BJ, Goh AC.
Performance of robotic simulated skills tasks is positively associated with clinical robotic surgical performance. BJU Int 2016; 118: 475–81

 

2 Rassweiler MC, Mamoulakis C, Kenngott HG et al. Classification and
detection of errors in minimally invasive surgery. J Endourol 2011; 25:
1713–21

 

3 Sommer KJ. Pilot training: what can surgeons learn from it? Arab J Urol 2014; 12: 32–5
4 Klein J, Teber D, Frede T et al. Development, validation and operating room of a six-step laparoscopic training program for the vesicourethral anastomosis. J Endourol 2013; 27: 349–54

 

5 Shamim Khan M, Ahmed K, Gavazzi A et al. Development and
implementation of centralized simulation training: evaluation of
feasibility, acceptability and construct validity. BJU Int 2013; 111:
518–23

 

6 Baumhauer M, Feuerstein M, Meinzer HP, Rassweiler J. Navigation in
soft tissue surgery: perspectives and limitation. J Endourol 2008; 22: 751–66

 

Editorial: Tailored prostate cancer survivorship: one size does not fit all

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One of the great triumphs in Urology is the transition of prostate cancer surgery from a universally morbid operation to one that now focuses on postoperative quality of life. This paradigm of cancer survivorship focuses on managing new, recurrent, or persistent symptoms. In this article by Bernat et al. [1], men within the Michigan Prostate Cancer Survivor Study were surveyed to identify factors that increase the need for additional prostate cancer survivorship information. Previous studies have shown discrepancies between subsets of prostate cancer survivors, based upon social, pathological, and treatment-based factors [2-5]. Indeed, the need for improved patient-centric information for all cancer survivors has resulted in the American Cancer Society publishing guidelines on how to best manage prostate cancer survivors, which account for four of every 10 male cancer survivors [6].

The authors [1] identify several critical aspects of post-treatment prostate cancer survivors. First, more than half of patients needed more information about their symptoms. This may be a departure from the views of many urological surgeons, who believe their patients are symptom-free after treatment. Second, the information needs of respondents were intuitively tied to their specific symptoms. For example, men who received combined therapy – thus, suggesting concern for incomplete control with primary treatment – were more concerned about recurrence; married men were more concerned about the effects of prostate cancer on their significant other; and men with more profound bowel or sexual symptom burdens were more concerned about the long-term effects and recovery period. Third, prostate cancer survivors remain concerned about diagnosis and treatment of their disease, even after they have received curative treatment. Topics such as early detection, diagnosis, and prevention of cancer were identified in double-digit percentages of respondents. Finally, there exists a correlation between the severity of symptom burden and associated information needs. A subset of symptoms (urinary, sexual, and bowel) may be directly related to treatment techniques and technologies. Thus, improvements in these fields may have long-term survivorship benefits.

While enlightening, these results are nevertheless susceptible to the inherent limitations of a survey-based study. Selection bias suggests that the true range of information needs and associated symptom burdens are not completely captured in these results. Additionally, these findings are not subdivided based on pathological stage or treatment method, which probably play important roles in cancer treatment, post-treatment symptoms, and patient concerns.

What are we to do with the results presented in this report? Clearly, easy access to informational resources about cancer survivorship needs to be offered as a standard of care for men with prostate cancer, which should be initiated before starting treatment. Additionally, men who are at-risk for requiring additional information on cancer survivorship (non-White race, received multimodality treatment, recurrent cancer, or high symptom burden) should receive additional counselling to ensure their informational needs are met. Finally, studies validating the effectiveness of these resources should be studied prospectively. Just as no two prostates are the same, so too should the paradigm be for prostate cancer treatment and survivorship.

Read the full article
Michael H. Johnson

 

Department of Urology, The James Buchanan Brady Urological Institute, Baltimore, MD, USA

 

1 Bernat JK, Wittmann DA, Hawley ST et al. Symptom burden and information needs in prostate cancer survivors: a case for tailored long-term survivorship care. BJU Int 2016; 118: 372–78

 

2 Hudson SV, O’Malley DM, Miller SM. Achieving optimal delivery of follow-up care for prostate cancer survivors: improving patient outcomes. Patient Relat Outcome Meas 2015; 6: 75–90

 

3 Bourke L, Boorjian SA, Briganti A et al. Survivorship and improving quality of life in men with prostate cancer. Eur Urol 2015; 68: 374–83

 

4 Chamie K, Connor SE, Maliski SL, Fink A, Kwan L, Litwin MS. Prostate cancer survivorship: lessons from caring for the uninsured. Urol Oncol

 

2012; 30: 102–8
5 AmericanCancerSociety. National Cancer Survivorship Resource Center. Avaliable at: https://www.cancer.org/survivorshipcenter. Accessed October 2015

 

6 Gore JL, Kwan L, Lee SP, Reiter RE, Litwin MS. Survivorship beyond convalescence: 48-month quality-of-life outcomes after treatment for localized prostate cancer. J Natl Cancer Inst 2009; 101: 888–92

 

Editorial: Optimal Thromboprophylaxis Remains a Challenge

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The ‘Guideline of guidelines: thromboprophylaxis for urological surgery’, published in this month’s issue of BJUI by Violette et al. [1], addresses a critical issue in urological practice and offers a comprehensive overview of available guidelines. Many urological surgeries, especially cancer surgeries, present a significant risk of thromboembolism, as well as bleeding. Therefore, urological surgeons should be well educated in the matter in order to be able to offer optimal prophylaxis to patients. Reading through the current recommendations and guidelines, one realises the wide variety of possible ways to risk stratify a patient, but also the large differences in opinions on how and when to offer prophylaxis. Consequently, even members within the same national society treat their patients in completely different ways.

The ideal recommendation will have to be individualised, taking thromboembolic and bleeding risk into account for each individual patient and specific surgery type. This stratification of patients not only presents a challenge in clinical practice but also for the design of meaningful clinical trials. As many medical questions regarding thromboprophylaxis remain unanswered, the currently available recommendations are based on our pathophysiological understanding and remain eminence-based, rather than evidence-based.

For many years, the ‘Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines’ [2] were viewed as the most respected guidelines in surgery. They include recommendations for a wide variety of surgical procedures, including urological surgeries. With an ageing population, our patients will more often be on anticoagulant treatment before surgery. While most guidelines still recommend stopping the anticoagulant treatment and bridging with heparin, new evidence from randomised controlled trials [3, 4] indicate that bridging by heparin significantly increases the risk for major bleeding without reducing the thromboembolic risk in most patients. Despite a recent appeal by internists and cardiologists [5], revised guidelines from the American College of Chest Physicians to replace the partially outdated recommendations have yet to be published. As mentioned by Violette et al. [1] in their current review, bridging should probably only be offered to a limited number of patients with a very high risk of thromboembolic complications.

Whether the recommendations for acetylsalicylic acid prophylaxis will be changed similarly (to stopping perioperatively in all but high-risk patients) is less clear [6]. More clinical evidence is needed here.

The European Association of Urology has recognised the problem and presented the prospect of providing a guideline on thromboprophylaxis for urological procedures later this year. Looking at the landscape of available high-quality publications it will still be highly challenging to provide clear recommendations for urological surgeries. The key to a comprehensive application will be the clinical practicality. With this review, the authors have set the stage to a critical review of the recommendations from a urological point of view.

Read the full article

 

Daniel Eberli
University and University Hospital of Zurich, Zurich, Switzerland

 

References

 

1 Violette PD, Cartwright R, Briel M, Tikkinen KAO, Guyatt GH. Guideline of guidelines: thromboprophylaxis for urological surgery. BJU Int 2016; 118: 351–58

 

2 Douketis JD, Spyropoulos AC, Spencer FA et al. Perioperative management of antithrombotic therapy: antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl.): e326S–50S

 

3 Steinberg BA, Peterson ED, Kim S et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation 2015; 131: 488–94

 

4 Douketis JD, Spyropoulos AC, Kaatz S et al. Perioperative bridging anticoagulation in patients with atrial fibrillation. N Engl J Med 2015; 373: 823–33

 

5 Rose AJ, Allen AL, Minichello T. A call to reduce the use of bridging anticoagulation. Circ Cardiovasc Qual Outcomes 2016; 9: 64–7

 

6 Devereaux PJ, Mrkobrada M, Sessler DI et al. Aspirin in patients undergoing noncardiac surgery. N Engl J Med 2014; 370: 1494–503

 

Editorial: Active surveillance for prostate cancer: is it too active?

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The wide dissemination of prostate cancer screening has increased the number of men diagnosed with low-risk, indolent cancers that are better managed with active surveillance (AS) rather than immediate treatment. During the past decade, the number of men managed with AS has increased from <10% to 40% in community based practice registries [1]. Prostate needle biopsy has a central role in diagnosis and reclassification of cancer for men on AS, and the number of these procedures has increased on an individual patient level and overall in the population. The rise of prostate biopsies repeated in the same patients has mirrored the increased rate of biopsy related infectious complications. An association between the number of repeat prostate biopsies and risk of infectious complications was reported in a single-centre observational study [2].

In this issue of BJUI, Bokhort et al. [3] report the risk of complications of serial prostate biopsies in men on AS in the multi-institutional Prostate cancer Research International Active Surveillance (PRIAS) study. Although they did not identify the number of previous biopsies as an independent predictor of infection, the type of prophylactic antibiotic was associated with risk of infection. Overall, one in five men reported any complication during AS and the rate of infectious complications was 2.5%. These figures are more relevant if we consider that men in whom an infection occurred were twice as likely to discontinue AS. Although the rate of attrition may have confounded the association of repeat biopsies on infectious complications or guided a more augmented antibiotic prophylaxis regimen, the most important finding of this study remains the significant morbidity associated with AS.

In the PRIAS study, institutions are guided to perform surveillance biopsies at 1, 4, and 7 years after the diagnostic biopsy. However, the schedule of biopsies varies significantly globally across institutions. In some academic centres, prostate biopsies are taken annually for men on AS, while other experts in AS have discussed taking biopsies every 5 years [4, 5]. As more studies emerge demonstrating the oncological safety of AS, we must address how ‘active’ AS should be and develop individualised recommendations based on tumour characteristics. A barrier to AS remains the burden of morbidity associated with prostate biopsies and efforts to reduce these procedures will contribute to further reducing the overtreatment of men with low-risk prostate cancer. In addition, the patient costs associated with serial office visits and the burden on physicians and healthcare systems stemming from the increased clinical volume following these patients remain an unmet need for the future.

Read the full article

 

Behfar Ehdaie
Department of Surgery, Urology Service, and Department of Epidemiology and Biostatistics, Center of Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center, New York, NY, USA

 

References

1. Cooperberg MR, Carroll PR. Trends in management for patients with localized prostate cancer, 1990–2013. JAMA 2015; 314: 80–2

2. Ehdaie B, Vertosick E, Spaliviero M et al. The impact of repeat biopsies on infectious complications in men with prostate cancer on active surveillance. J Urol 2014; 191: 660–4

3. Bokhorst LP, Lepistö I, Kakehi Y et al. Complications after prostate biopsies in men on active surveillance and its effects on receiving further biopsies in the Prostate cancer Research International: Active Surveillance (PRIAS) study. BJU Int 2016; 118: 366–71

4. Tosoian JJ, Mamawala M, Epstein JI et al. Intermediate and longer-term outcomes from a prospective active-surveillance program for favorable-risk prostate cancer. J Clin Oncol 2015; 33: 3379–85

5. Klotz L. Active surveillance: current and future directions. Curr Opin Urol 2013; 23: 237–8

 

 

Editorial: Robot-assisted partial nephrectomy: excellent outcomes can persist despite previous abdominal surgery

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Robot-assisted surgery is increasing and patient selection is important to ensure mitigation of risk, patient safety and allow for the surgeon’s training curve. This is especially pertinent for robot-assisted partial nephrectomy (RAPN), as increasingly complex tumours and increasingly complex patients are considered potentially suitable. One factor that contributes to patient complexity is the presence of intra-abdominal adhesions, which can be predicted by previous abdominal surgery. This month’s article by Abdullah et al. [1] ‘Multicentre outcomes of robot-assisted partial nephrectomy after major open abdominal surgery’ eloquently describes their outcomes in patients who underwent RAPN with a history of previous open abdominal surgery.

The study retrospectively analysed 1 686 patients who had undergone RAPN from a prospective database from five large American academic institutions. A sub-group of 216 patients (13%) had undergone major prior abdominal surgery (PAS); this was defined as those marked by upper midline or ipsilateral incisions. The authors chose such incisions due to the increased potential for adhesions within the expected surgical field for RAPN, which could interfere with performance [2]. The list of prior surgeries is wide ranging such as laparotomy, open cholecystectomy, open appendicectomy and open ipsilateral PN; 12% (25 patients) had had multiple previous procedures.

The study found that there was no statistical difference between the two groups in the areas of Charlson comorbidities index, tumour size, R.E.N.A.L. nephrometry score [consists of (R)adius (tumour size as maximal diameter), (E)xophytic/endophytic properties of the tumour, (N)earness of tumour deepest portion to the collecting system or sinus, (A)nterior (a)/posterior (p) descriptor and the (L)ocation relative to the polar line], and preoperative estimated GFR. They also found no difference between intraoperative and postoperative complications (<4% Clavien ≥3 in PAS group), positive surgical margins and change in renal function.

Their initial concern that previous surgery increases robotic operative time was ill founded, as there was no statistical difference in median (interquartile range) operative times: PAS 172 (132–224) vs169 (139–208) min. However, they did find statistical difference in estimated blood loss, which was higher in the PAS group (150 vs 100 mL; P = 0.039); but this did not translate to a difference in transfusion rates.

They also found the PAS patients were older (median 63 vs 60 years) and had a higher median body mass index (30.3 vs 29 kg/m2). This is an important finding in the context of offering robotic minimally invasive surgery in an increasingly obese and ageing surgical population.

Achieving safe access is a crucial step in all laparoscopic or robot-assisted surgery and is potentially complicated by the presence of adhesions. It was of particular interest to read of the access techniques used: Hasson vs Veress needle vs retroperitoneal approach. The latter was used more in the PAS group (11.2% vs 5.4%), despite a lower percentage of posterior tumours (38.8% vs 43.3%). This suggests surgical preference for choosing a retroperitoneal approach was related to avoidance of potential adhesions rather than tumour location.

Conceptually the Hassan technique, with access achieved by direct vision, could offer safety benefits in the presence of potential adhesions; however, access via Veress needle insufflation occurred in most of their cases. The authors describe the use of the Hassan technique in instances of failure of Veress access but the incidence that this occurred is not provided. They estimated that 24 cases were converted to open due to access-related issues.

Further interrogation of the 180 open PNs performed during the study period could provide a valuable comparative group and understand why they were not deemed suitable for a robot-assisted approach.

The study can be commended for its large patient database, multicentre design, and breadth of outcomes assessed. It supports the findings of Zargar et al. [3] showing comparable perioperative complications and open conversions of RAPN in patients with and without a history of PAS in their similar sized, but single-centre study. This is also in agreement with assessments of other robotic procedures supporting the relative safety of robotic surgery in patients with a history of PAS.

One of the limitations of this study is the lack of discussion on the decision-making process for choice of access technique. Individual surgeons and/or the recommendations of multi-disciplinary teams will favour the technique with the perceived best outcome and may select out more favourable cases to each arm. Abdullah et al. [1] results may be an indication of appropriate technique selection rather than safety of the robot or individual access techniques.

This study provides robotic surgeons with increasing confidence to offer RAPN and its potential advantages of reduced blood loss, pain and recovery time to patients despite the presence of potential adhesions from PAS. Individual case selection remains imperative to maintain optimal surgical outcomes. Complex cases may be safely tackled in high-volume established RAPN programmes; but they may not be suitable for surgeons earlier in their experience. Robotic surgeons should be well trained and confident in managing the potential complications of bowel injury in these challenging cases.

Sophie Rintoul-Hoad, Rick Catterwell and Ben Challacombe
Urology Centre, Guy’s and St Thomas’ Hospitals NHS Trust, Great Maze Pond, London, UK

 

Read the full article

 

References

 

1 Abdullah N, Rahbar H, Barod R et al. Multicentre outcomes of robot- assisted partial nephrectomy after major open abdominal surgery. BJU Int 2016; 118: 298–301

 

2 Liakakos T, Thomakos N, Fine PM, Dervenis C, Young RL. Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Recent advances in prevention and management. Dig Surg 2001; 18: 260–73

 

3 Zargar H, Isac W, Autorino R et al. Robot-assisted laparoscopic partial nephrectomy in patients with previous abdominal surgery: single center experience. Int J Med Robot 2015; 11: 389–94

 

Editorial: Management Dilemmas in Low-Risk Prostate Cancer

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Prostate cancer is the most commonly diagnosed solid organ tumour and the second leading cause of cancer death in men in the USA. The exact path of these tumours from inception to metastasis is unclear; the same can also be said for those tumours that remain indolent. The varying genetic signatures of these tumours is the underlying determinant of the outcomes of these cancers and therein lies the key to selecting patients that do and do not need treatment for their prostate cancers. Most low-risk tumours are relatively indolent; however, some low-risk tumours have the potential to metastasise and cause mortality. The problem is that currently we do not have the ability to accurately and confidently determine the tumour’s individual risk profiles.

In the recent LAPPRO trial (LAParoscopic Prostatectomy Robot Open – a randomised, open trial of radical prostatectomy (RP) with or without lymph node dissection as part of a prospective, non-randomised, open trial comparing robot-assisted laparoscopic and open RP), the authors reported the RP results of patients with very-low-risk prostate cancer in a population-based study from Sweden compiling the results of open and laparoscopic RP over 14 centres of varying experience [1]. They reported pathological upgrading in 35% of patients and PSA recurrence in 2.1%. Functional outcomes at 1 year featured urinary continence levels of 84% and sexual potency of 44%. The overall trifecta rate at 1 year was 38%. What is important to note is that only 56% had optimal erectile function preoperatively (Sexual Health Inventory for Men score >21) and that it is unknown which patients received a full nerve preservation. Also the amount of postoperative continence and potency rehabilitation is unknown.

The results of the LAPPRO trial are not too dissimilar to data from the Medicare database publications on RP, which also take into account large populations of patients operated on at multiple institutions with variable surgical experience and volume [2]. The challenge with interpreting these data is that they often are quite variable based upon the preoperative status of the patient, type of surgery performed, surgeon experience, and institutional volumes [3]. If you compare the Medicare data or LAPPRO trial outcomes to large-volume single-surgeon series you often will see wide variances in outcomes favouring the single-surgeon experience. Single-surgeon and large-volume series have reported better outcomes often due to improved surgical experience, techniques, and outcomes overall [4].

Active surveillance is usually the primary choice for management of low- and very-low-risk prostate cancer lesions. However, some patients do still chose to undergo surgery due to personal choice, often related to the uncertainty associated with the diagnosis and the unknown risk of progression [5]. One would assume that low-risk tumours have a low risk of progression and metastasis; however, this is not always the case due to the varying genetic signature of the individual tumours. Also, recent studies have shown that in patients diagnosed with low-risk prostate cancer 30–50% have non-low-risk disease harbouring intermediate- or high-risk prostate cancer instead [1, 6]. This uncertainty on the part of the patient and physician can cause anxiety in patients and sometime influence their decision for treatment [7].

One would assume that patients with low- and very-low-risk patients are ideal candidates for the trifecta due to low tumour aggressiveness and volume. However, many factors influence patient outcome beyond the characteristics of the tumour. Preoperative features such as co-morbidities and pre-existing sexual dysfunction or incontinence are influential. Operative and postoperative factors include: surgeon experience, institutional volume, patients body habitus, number of prior biopsies, the ability to fully spare the nerves, and various other challenges during surgery. These are all variables that must be considered when projecting the success of surgical intervention.

While the results of surgery in the LAPPRO trial were not encouraging for surgery, we do have to take the results in context and not apply them broadly or globally without some thought. The results are blurred by combining open and laparoscopic RP, many patients were not optimal candidates’ preoperatively for the trifecta, many did not have a full nerve preservation and also many different institutions with varying levels of surgeon experience are analysed. This population was also ‘captive’, as they had to choose surgeons in their own locality, these ‘local’ surgeons may not have had the necessary experience or technique to achieve optimal outcomes. The conclusion that can be drawn is that if you sample a broad population of surgeons then the results are often quite poor due to the varying levels of skill of the surgeon and the varying level of surgical volume and experience. What the patients should glean from this is the fact that they should consider active surveillance for these types of tumours to avoid the associated morbidity. In addition, if they were to seek therapy they should select centres with higher surgical experience and proven outcomes.

For those patients that have low-risk tumours and seek treatment; judicious counselling of expectations must be performed by their healthcare advocate. Both the patient and physician must take the responsibility in making the correct assumptions and decisions. The physician must re-emphasise the available data and the low likelihood of progression in these tumours adding some caution from the fact that some of these may be upgraded. Patients must be given accurate data in the correct context. Most patients who have treatment for prostate cancer whether it be radiation, ablation or removal have a high chance of some deficit in the quality of life, functional recovery of urinary continence, and sexual potency. Educating the patient and managing realistic expectations is often the most important factor in patient satisfaction. Patients must take into account their own preoperative medical and functional status to properly stratify expectations.

If these patients after appropriate counselling are still intent to undergo surgery they should consider seeking centres with high-volume and individualised surgeons with proven quality outcomes. Large-volume single-surgeon series do show improvements in the trifecta outcomes [4]. However, none have shown perfect trifecta rates. No matter what method of treatment patients chose there would be some varying level of loss of functional outcome. The balance between cancer progression and quality of life must be weighted. For low-risk patients, we need to have a better road map of the genetic signatures of their tumour and only then will we be able to confidently tell our patients who will and who will not have the potential to harbour high-risk disease and potentially have mortality from the tumour. Until we are able to confidently deliver this information to the patient, many with low-risk disease will still seek treatment and endanger their quality of life. The recent increase in the availability of biomarkers to examine prostate biopsy specimens for risk stratification is encouraging, yet still in its infancy. Further study of these biomarkers will enhance our ability to read the genetic signature of prostate cancers at an early state and more appropriately risks stratify our patients.

The LAPPRO trial supports active surveillance as the primary choice for low- and very-low-risk tumours. However, their results are exclusive to their patient population and level of surgical experience. A similar trial with a high-volume experienced surgeon would undoubtedly show more optimistic results. Managing reasonable expectations, risk stratification, and picking expertise and experience, often makes the difference between a good and poor outcome.

Read the full article

 

Vipul R. Patel*† and Hariharan Palayapalayam Ganapathi*†
*Global Robotics Institute, Florida Hospital Celebration Health, and †University of Central Florida School of Medicine, Orlando, FL, USA

 

References

 

1 Carlsson S, Jaderling F, Wallerstedt A et al. Oncological and functional outcomes 1 year after radical prostatectomy for very-low-risk prostate cancer: results from the prospective LAPPRO trial. BJU Int 2016; 118: 205–12

 

2 Barry MJ, Gallagher PM, Skinner JS, Fowler FJ Jr. Adverse effects of robotic-assisted laparoscopic versus open retropubic radical prostatectomy among a nationwide random sample of Medicare-age men. J Clin Oncol 2012; 30: 513–8

 

3 Patel VR, Abdul-Muhsin HM, Schatloff O et al. Critical review of ‘pentafecta’ outcomes after robot-assisted laparoscopic prostatectomy in high-volume centres. BJU Int 2011; 108: 1007–17

 

4 Patel VR, Coelho RF, Chauhan S et al. Continence, potency and oncological outcomes after robotic-assisted radical prostatectomy: early trifecta results of a high-volume surgeon. BJU Int 2010; 106: 696–702

 

5 Simpkin AJ, Tilling K, Martin RM et al. Systematic review and meta-analysis of factors determining change to radical treatment in active surveillance for localized prostate cancer. Eur Urol 2015; 67: 993–1005

 

6 El Hajj A, Ploussard G, de la Taille A et al. Analysis of outcomes after radical prostatectomy in patients eligible for active surveillance (PRIAS). BJU Int 2013; 111: 53–9

 

7 Van den Bergh RC, Essink-Bot ML, Roobol MJ et al. Anxiety and distress during active surveillance for early prostate cancer. Cancer 2009; 115: 3868–78

 

The impact factor may be flawed but important

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It has been a nice summer for the BJUI. Our impact factor has gone up to 4.387, the highest ever in the history of the Journal and we made the Altmetrics Top 50 for the first time ever with a score of 1166, Nature being the numero uno. I wanted to thank our editorial team, readers, authors and reviewers for their dedication and commitment, which made this possible.

bju13563-fig-0001

 

The question is how did we do this? For a journal without official society guidelines, it was not easy. So we had to focus on original articles rather than reviews and guidelines. There were three essential steps:

  1. Publishing the highest quality, citable papers irrespective of geographical location [1] – for example, this month we have highlighted the importance of personalised medicine in BPH from Taiwan [2], whereby the authors show that an endothelial nitric oxide synthase (eNOS) genetic polymorphism has a negative impact on response to α-blockers.
  2. Reducing the number of papers published while selecting clinically relevant, large prospective studies and trials – an example of this is the LAParoscopic Prostatectomy Robot Open (LAPPRO) study from Sweden [3], showing that even in very-low-risk prostate cancer, upgrading after radical prostatectomy occurs in over a third of patients and that the functional outcomes are not as good as expected.
  3. Amplifying our content through social media – this means that we believe in interaction with a wider audience, immediacy of response, and are not afraid of the occasional controversy and debate. An example is the comment on clostridium histolyticum collagenase followed by a brief editorial on what may increasingly be seen as an important treatment option for Peyronie’s disease [4].

Many consider the impact factor of a journal as a ‘gaming’ exercise, flawed by its very nature. I was very pleased to receive a WhatsApp from one of my colleagues saying how pleased he was that at the BJUI we have always played ‘with a straight bat’. An important consideration is that Universities often count original papers in the best journals for measuring academic output, which in turn drives income from various sources. In the UK this is given the term ‘returnable’ when considered within a system called the Research Excellence Framework. I am really pleased that the BJUI is now ‘returnable’ with its new impact factor and is seen as a serious player within a highly demanding system. I am aware that this also true for other international institutions, which is in keeping with our global presence as a journal without boundaries.

Prokar Dasgupta @prokarurol
Editor-in-Chief, BJUI 

References

1 Dasgupta P. Quality has no boundaries. BJU Int 2014; 113: 1

 

2 Lee Y-C, Juan Y-S, Liu C-C et al. The association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective a 1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms. BJU Int 2016; 118: 313–19

 

3 Carlsson S, Jaderling F, Wallerstedt A et al. Oncological and functional outcomes 1 year after radical prostatectomy for very low risk prostate cancer. Results from the prospective LAPPRO trial. BJU Int 2016; 118: 205–12

 

4 Poullis C, Shabbir M, Eardley I, Mulhall J, Minhas S. Clostridium histolyticum collagenase – Is this revolutionary medical treatment for Peyronie’s disease? BJU Int 2016; 118: 186–92

 

Editorial: Responsiveness to Medical BPH Therapy – Is There a Genetic Factor?

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In this issue, Lee et al. [1] from Taiwan demonstrate that the endothelial nitric oxide synthase (eNOS) G894T gene polymorphism predicts responsiveness to α1-blocker therapy in men with BPH/LUTS.

There is a long-standing interest in the establishment of a genetic marker for BPH/LUTS predicting clinical status, the natural history and – ideally – also responsiveness to for example medical therapy. The high prevalence of disease, the socioeconomic impact of diagnosis, medical and surgical treatment, and the availability of drugs (5α-reductase inhibitors) that alter the natural course of the disease justify the intensive search for a genetic marker for BPH/LUTS.

The few familial and twin studies suggest a (moderate) genetic background for this disease to an extent similar to other chronic diseases such as hypertension or diabetes mellitus type II [2, 3]. However, BPH/LUTS is a complex disorder and it is very unlikely that the pathogenesis can be reduced to a single gene or gene defect. Most likely, genetic alterations – besides inflammation, endocrine, myogenic, neurogenic, and morphological factors – act as co-factors.

Within the past decade numerous polymorphisms in the steroid-metabolism pathway, in cytokine genes, in the vitamin D receptor gene, the α-adrenoceptor gene, in homeobox genes, in the angiotensin converting enzyme, the glutathione S-transferase gene, and in the nitric oxide system (just to mention the most frequently studied ones) have been correlated to several clinical parameters of BPH/LUTS, such as symptom status, prostate volume, maximum urinary flow rate and the natural history of the disease [4, 5]. None of these studies provided compelling evidence that one of these polymorphisms (or combinations thereof) could serve as a clinically relevant marker [4, 5]. As indicated by Cartwright et al. [5], many of these genetic studies are hampered by a small sample size, lack of genotyping quality control, inadequate adjustment for populations from heterogeneous descent groups, and poorly defined/inhomogeneous study endpoints.

There is increasing evidence that the nitric oxide (NO)/cGMP pathway plays an important role in controlling the smooth muscle tone of the lower urinary tract. Decreases in the NO/cGMP pathway with age would result in decreased levels of intracellular cGMP and calcium, leading to less smooth muscle relaxation of the bladder and the prostate, thus worsening LUTS. NO is synthesised by at least three isoenzymes of NOS, inducible NOS (iNOS), neuronal NOS (nNOS) and eNOS [1]. The close relationship between NOS/NO pathway and the pathophysiology of BPH/LUTS was the rationale for the study by Lee et al. [1]. Using multiple logistic regression analysis adjusted for age and IPSS, the data showed that the eNOS 894T allele carrier was an independent factor for drug non-responders [1]. However, responsiveness to α1-blocker therapy was also strongly dependent on diabetes mellitus and hypertension, suggesting that the metabolic syndrome plays an important role in the pathogenesis of BPH/LUTS [1]. This is indeed the first study showing that a genetic factor is predictive of the responsiveness to medical BPH/LUTS therapy, therefore this study is significant.

Further studies in populations with other genetic backgrounds (e.g. Caucasian) are required to confirm and to generalise these data. Phosphodiesterase type 5 inhibitors have been proposed to act in BPH/LUTS via the NO systems; therefore, it would be interesting to test this genetic marker also in men treated with tadalafil 5 mg/day. Finally, one has to be aware of the fact that the authors have tested α-blocker monotherapy. All major guidelines recommend a combination of α-blocker and 5α-reductase inhibitor for men with larger prostates (e.g. prostate volume >30–40 mL) [6]. The mean prostate volume in this cohort was 35 mL suggesting that, according to guideline recommendations, these men would have required combined therapy [6].

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Stephan Madersbacher, Professor and Chairman
Department of Urology, Kaiser-Franz-Josef Spital, Vienna, Austria

 

References

 

1 Lee Y-C, Juan Y-S, Liu C-C et al. The association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective a 1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms. BJU Int 2016; 118: 313–19

 

2 Partin AW, Page WF, Lee BR, Sanda MG, Miller RN, Walsh PC. Concordance rates for benign prostatic disease among twins suggest hereditary influence. Urology 1994; 44: 646–50

 

3 Rohrmann S, Fallin MD, Page WF et al. Concordance rates and modifiable risk factors for lower urinary tract symptoms in twins. Epidemiology 2006; 17: 419–27

 

4 Konwar R, Chattopadhyay N, Bid HK. Genetic polymorphism and pathogenesis of benign prostatic hyperplasia. BJU Int 2008; 102: 536–43

 

5 Cartwright R, Mangera A, Tikkinen KA et al. Systematic review and meta-analysis of candidate gene association studies of lower urinary tract symptoms in men. Eur Urol 2014; 66: 752–68

 

6 Gravas S, Bach T, Bachmann A et al. Treatment of Non-Neurogenic Male LUTS. Available at: www.uroweb.org. Accessed March 2016.

 

Editorial: Role of systematic biopsy in the era of mpMRI and US fusion guidance

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The success of multiparametric MRI (mpMRI) and MRI/ultrasound (US) fusion-guided biopsies in improving the detection of prostate cancer in patients with occult disease (elevated PSA level with prior negative biopsies) and optimising the detection of clinically significant cancer has been reported by centres that have served as early adopters of these techniques [1, 2]. Technological advances in MRI and associated imaging protocols, as well as increased clinical experience with MRI interpretation have led to increased prospective detection and characterisation of clinically significant prostate cancer. This, in conjunction with increasing experience with MRI/US fusion-guided prostate biopsy techniques, has led to the re-evaluation of the contributory role and utility of systematic template US-guided prostate biopsies in the diagnosis of prostate cancer. It is an attractive proposition to forego the systematic biopsy when performing MRI-directed fusion biopsy, as this would minimise the duration, morbidity, and overall cost of the biopsy procedure and post-biopsy pathology processing. However, before adopting this approach, it is important to first consider the potential possibility of missing clinically significant cancer diagnoses when relying on the targeted biopsy cores in isolation.

In this issue of BJUI, Borkowetz et al. [3] report their results of biopsy histological yields on systematic biopsies compared with MRI/US fusion biopsies in their series of patients who underwent radical prostatectomy (RP). These results corroborate previously reported comparisons of fusion biopsy of suspicious lesions on MRI performed concurrently with systematic biopsy, consistently showing an improved detection of both overall prostate cancer foci and, more importantly, an improved detection of clinically significant higher grade cancer foci [1, 2]. It is important to note that the overall detection rate and detection rate for clinically significant prostate cancer was highest when fusion and systematic biopsies were evaluated in conjunction with each other. Another important factor to consider when evaluating the utility and value of these biopsy techniques is the concordance of the pathology of the biopsy specimen with the final pathology of the RP specimen, the ‘gold standard’. The concordance of Gleason grade assigned on targeted fusion-biopsy cores and RP outperformed that of systematic biopsy cores and RP. This, in essence, suggests that targeted biopsy can perform as well, and likely better, than the systematic biopsy approach of sampling the prostate with a systematic-sextant approach, which has been the long standing standard of care for the diagnosis of prostate cancer. Again, it is important to note that the greatest concordance in this study was achieved when the results of the fusion and systematic biopsy cores were combined.

The question now arises regarding the ‘cost’ for the incremental improvement in cancer detection provided by the combination of both MRI-directed fusion biopsy and the systematic biopsy approach. The improved negative predictive value parallels the increased sensitivity for cancer detection by having a larger sampling of the prostate by augmenting the number of biopsy cores sampled and submitted for histopathological evaluation. The area under the curve for detection of clinically significant cancer reported by Borkowetz et al. [3] was not improved by adding systematic biopsies to the targeted biopsies. However, this experience described a mixed population of patients, most of whom had undergone prior prostate biopsy with benign pathology. This creates an enriched population who likely harbours prostate cancers that are more occult to the systematic biopsy approach, thus improving the diagnostic yield of MRI-directed biopsies even further. This is concordant with the work presented by Mendhiratta et al. [4], where systematic biopsies added little to the diagnosis of clinically significant prostate cancer in a population of men undergoing MRI/US fusion-guided biopsy after prior cancer-negative biopsy sessions.

Alternatively, current datasets for biopsy naïve patients have not shown the same degree of convincingly improved detection with targeted biopsies over systematic biopsies. In fact, Delongchamps et al. [5] recently reported a slightly lower rate of overall cancer detection with fusion-guided targeted biopsies vs systematic biopsy cores; however, the difference in detection of clinically significant prostate cancer was not statistically significant. Further study of the role of targeted biopsy in the biopsy naïve patient population is warranted, as there is suggestion that cancer detection efficiency per needle core is significantly improved with MRI-directed biopsies over systematic biopsies [6]. Alternatively, in patients with prior negative systematic biopsies and continued clinical suspicion for prostate cancer, a repeat biopsy session with targeted cores alone may be appropriate, particularly as these patients have previously undergone standard-of-care, extended sextant biopsy.

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Jason A. Pietryga* and Soroush Rais-Bahrami*,†
*Department of Radiology, and †Department of Urology, University of Alabama at Birmingham, Birmingham, AL, USA

 

References

 

1 Siddiqui MM, Rais-Bahrami S, Turkbey B et al. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA 2015; 313: 390–7

 

2 Sonn GA, Chang E, Natarajan S et al. Value of targeted prostate biopsy using magnetic resonance-ultrasound fusion in men with prior negative biopsy and elevated prostate-specific antigen. Eur Urol 2014; 65: 809–15

 

3 Borkowetz A, Platzek I, Toma M et al. Direct comparison of multiparametric magnetic resonance imaging (MRI) results with final histopathology in patients with proven prostate cancer in MRI/ultrasonography-fusion biopsy. BJU Int 2016; 118:213–20

 

4 Mendhiratta N, Meng X, Rosenkrantz AB et al. Prebiopsy MRI and MRI-ultrasound fusion-targeted prostate biopsy in men with previous negative biopsies: impact on repeat biopsy strategies. Urology 2015; 86:1192–9

 

5 Delongchamps NB, Portalez D, Bruguiere E et al. Are MRI-TRUS-guided targeted biopsies non-inferior to TRUS-guided systematic biopsies for the detection of prostate cancer in patients with a single suspicious focus on multiparametric prostate MRI? Results of a multicentric controlled trial. J Urol 2016; [Epub ahead of print]. DOI: 10.1016/ j.juro.2016.04.003

 

6 Siddiqui MM, George AK , Rubin R et al. Comparison of biopsy efficiency between MR/Ultrasound fusion guided biopsy and standard extended-sextant biopsy in men with MR-visible lesions in the prostate. J Natl Cancer Inst 2016;108: pii: djw039. DOI: 10.1093/jnci/djw039

 

Editorial: Time to re-evaluate and refine re-TUR in bladder cancer?

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In this issue of BJUI, Gontero et al. [1] present data from a large multi-centre study that should allow us to re-evaluate and refine the indications for re-transurethral resection (TUR) in bladder cancer.

Herr [2] first described this procedure in 1999 and for the past 16 years the indications have remained largely unchanged and are summarised in the latest European Association of Urology guidelines on non-muscle-invasive bladder cancer (NMIBC) [3]:

  • After incomplete initial TUR of bladder tumour (TURBT).
  • If there is no muscle in the specimen after initial resection.
  • In all T1 tumours.
  • In all Grade 3 tumours except primary carcinoma in situ.

In a multi-centre retrospective study of 2 451 patients with high-grade (HG)/Grade 3 (G3) T1 NMIBC treated with BCG, Gontero et al. [1]examined 935 patients who had re-TUR (38% of the total, itself a low figure). Patients were divided into four groups according to the presence or absence of detrusor muscle in the first TURBT specimen:

  • No muscle, no re-TUR
  • No muscle, re-TUR
  • Muscle, no re-TUR
  • Muscle, re-TUR

The authors found that re-TUR only had a positive impact on recurrence, progression, cancer-specific and overall survival, if detrusor muscle was not present in the original specimen. Importantly, in the presence of detrusor muscle in the original specimen, re-TUR did not improve outcomes. The authors conclude that re-TUR may be unnecessary in HG/G3 T1 patients if detrusor muscle is present at the first TURBT.

These findings are important for two reasons: firstly, Herr’s [2] paper was the first to draw attention to the finding that TURBT, a routine urological procedure, was often carried out inadequately. In recent years, the importance of carrying out a high-quality TURBT has been increasingly recognised [4], whilst the presence of detrusor muscle in the TURBT specimen has been shown to be a good measure of the technical quality of a TURBT [5]. This paper [1] further reinforces the importance of obtaining detrusor muscle in the first TURBT. Indeed, as failure to do so results in the patient having to have a second operation and delays their treatment, perhaps we should start to think of a failure to obtain detrusor muscle at the first TURBT in much the same way as positive margin rates are used as a measure of the quality of radical prostatectomy and by inference, the skill of the surgeon.

Secondly, re-TUR arguably serves one overarching purpose: to identify patients with muscle-invasive bladder cancer (MIBC) who have been under-staged by an inadequate first TURBT and who without a re-TUR would be inadequately treated.

Although a secondary role of re-TUR is to identify patients with residual NMIBC, which has some prognostic value, in practice it rarely changes the patient’s management in this setting, which is intravesical therapy usually with BCG. However, in many healthcare systems the timely organisation of a re-TUR within the recommended 6 weeks is challenging and there is usually a further delay of at least 2 weeks until the pathology is reviewed and a patient with NMIBC can finally commence treatment. In this context, it is not surprising that a recent paper in BJUI showed that the interval to re-TUR was a predictor of recurrence and progression and that a re-TUR after 7 weeks was associated with a much worse outcome [6]. It therefore seems logical to reserve re-TUR only for those patients who truly need it, so that limited resources are focused on ensuring that they receive their operation in a timely manner, ideally within 2–4 weeks. If adopted into day-to-day urological practice, the findings by Gontero et al. [1] will allow many patients with HG/G3 T1 and detrusor muscle in the first TURBT specimen to avoid a re-TUR and start intravesical therapy without further delay. Pragmatically, the same should apply to patients with HG/G3 Ta with detrusor muscle in the specimen. On the other hand, HG/G3 T1 patients without detrusor muscle should be fast-tracked for re-TUR as soon as is practicable and certainly no later than 6 weeks.

The article [1] does have some shortcomings. The study design excludes patients with MIBC, so we do not know by comparison how many patients with MIBC were under-staged at the initial TUR based on subsequent re-TUR but as the authors point out, their conclusions would hold true even in this group, as it is very unlikely that one would miss MIBC if there was adequate detrusor muscle in the pathology specimen.

In conclusion, we should consider refining the indications for re-TUR to improve the utilisation of healthcare resources and ensure that for those that need it, a re-TUR is carried promptly whilst for those that do not, essential intravesical treatment is not delayed.

Read the full article
A. Hugh Mostafid, Consultant Urologist and Honorary
Senior Lecturer The Royal Surrey County Hospital, Guildford, Surrey, UK

 

References

 

1 Gontero P, Sylvester R, Pisano F et al. The impact of re-transurethral resection on clinical outcomes in a large multicentre cohort of patients with T1 high-grade/Grade 3 bladder cancer treated with bacille Calmette-Guerin. BJU Int 2016; 118: 44–52

 

2 Herr HW. The value of a second transurethral resection in evaluating patients with bladder tumors. J Urol 1999; 162: 74–6

 

3 Babjuk M, Bohle A, Burger M et al. Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1 and CIS). European Association of Urology, 2015. Available at: https://uroweb.org/wp-content/uploads/EAU-Guidelines-Non- muscle-invasive-Bladder-Cancer-2015-v1.pdf. Accessed 23 November 2015.

 

4 MostafidH, Brausi M. Measuring and improving the quality of transurethral resection for bladder tumour (TURBT). BJU Int 2012; 109: 1579–82

 

5 Mariappan P, Zachou A, Grigor KM. Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience. Eur Urol 2010; 57:
843–9

 

6 Baltaci S, Bozlu M, Yildirim A et al. Significance of the interval between first and second transurethral resection on recurrence and progression rates in patients with high-risk non-muscle-invasive bladder cancer treated with maintenance intravesical Bacillus Calmette-Guerin.
BJU Int 2015; 116: 721–6

 

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