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Hope for Haiti

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I am sure that many of you will recall the shocking images which went around the world in the aftermath of the devastating earthquake in Haiti in 2010. The scale of the devastation was quite shocking, even for a world that is getting used to scenes of terrible destruction following natural disasters. Over 100,000 people died and over 3 million were seriously affected. For those of us working in the region, the devastation is felt all the more, and long after the news crews and journalists have departed, we must pick up the pieces and try and rebuild our lives and those of our patients again. Three years later, over 250,000 people still live in tents following the earthquake and all of the aid money has been spent.

One of the practical issues for those of us working in healthcare in such a region is the rebuilding of infrastructure following such a calamity. The Caribbean Urological Association [CURA] is a very small player amongst the major organisations that seek to offer support to the Third World and most immediately to post-earthquake-ravaged Haiti. The purpose of our involvement is to ensure that each patient receives appropriate help. We may not be able to offer this help but we seek to provide the means that will provide help and we certainly need help in trying to achieve this.

Following lessons learned in the Haiti Hurricane, we suggest the following structured steps in managing such a recovery on a regional scale:

  1. Local Haitian experts are asked to compile a list of the most common urological conditions encountered in the aftermath and how they treat them. This information can be entered into a database which will advise donors/helpers on the most urgent and commonest needs. From the database a simple questionnaire can be developed for validation and follow up purposes. The questionnaire needs to be short and simple. Over-stretched doctors need all the time they have to care for patients. However accurate information is vital is one of the weak links in the immediate aftermath.
  2. Establish electronic contact with all urologists who will or who have started programmes of help to Haiti. Note geographic areas covered. Develop links to reduce duplication of efforts.
  3. We may need to reduce donor expectations. The Third World is 2 – 4 decades behind the First World. Retired experienced urologists can be involved and may function more efficiently under the conditions now present in Haiti. Probably not too different from where they started their own careers. They made do just as the Haitian urologists are making do. Innovation in the Third World is legendary.
  4. Facilities taken for granted may be absent. Continuous electricity, electronic contact, safe water and sanitation are not assured.
  5. Create tiered training programmes for local Haitian urologists at different levels.

Level 1 – Basic beginner-level urology, better started on the ground in Haiti. Use of symptoms scores etc. Manage urgent conditions e.g. acute urinary retention etc.

Level 2 – Develop confidence with greater experience. Introduction to endoscopic techniques etc.

Level 3 – Experienced senior urologists to staff Haitian tertiary centres.

A next level development is to look at workshops, tele-mentoring and telemedicine as electronic services become available, along with trips to overseas centres.

CURA can offer level II training in San Fernando, Trinidad. Candidate selection is done by the Haitian fraternity. Funding has to be sought for the six month training periods – SIU, AUA, BAUS, EAU and BJUI. Provide a certificate on completion of training and a basic urological kit for each trainee to be used in the public health sector. Request six month progress reports from each candidate.

CURA can also help with workshops if these are thought helpful. Trinidad is not far from Haiti as the crow flies. However, airlines have not learnt from crows.

The simplicity of this model places the people of Haiti and their care givers in the centre. International donor groups are placed peripherally with regional associations in the middle delivering help as required. International donor groups are an essential component since resources need to be sought here – human resources, equipment, access for tertiary training etc. The model can also be applied to other disadvantaged regions when faced with huge destruction following natural disaster.

Today it is Haiti, tomorrow who knows.

Haitian girl three years after quake.

The annual meeting of CURA is planned for October 25th – 27th 2014 in Trinidad. One or two papers have been accepted from Haitian urologists. The distinguished foreign faculty includes David Quinlan of BJUI, Richard Santucci of SIU, Arthur Burnett of Johns Hopkins, Josh Woods of IVU/Med, Grannum Sant of AUA. We hope to have an in depth discussion of the way forward for the Haiti/CURA relationship.

Dr Deen Sharma, Georgetown, Guyana

Editorial: Reach for the sky – tissue engineering in urology

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The work of Verdi et al. [1] published in this issue, shows the continuing quest to find a cellular substrate suitable for producing a tissue engineered replacement for detrusor smooth muscle. This study has identified the regenerative ability of endometrium and with the use of myogenic culture media has sought to differentiate stem cells of endometrial origin to produce the desired smooth muscle cells. The ultimate objective is to produce a functional organ replacement that improves on the current methods of tissue replacement. The current standard for bladder replacement is bowel, both large and small, in various eponymous configurations. All cystoplasties have the potential for long-term consequences including metabolic derangement, UTI, stone formation and mucus secretion [2]. They also suffer the limitation that they will not contract, thus between 10% and 75% will need to self-catheterise. However, many patients do very well after reconstruction with bowel, thus it is important that any substrate designed to replace the current standard matches and improves on that which bowel can offer.

The complex interactions required to achieve a functional bladder replacement are discussed by many authors and include that with urothelium [3], nerve growth and angiogenesis. Despite considerable ingenuity only some of these concerns are solved by previous approaches that have, for example, seeded urothelium onto a vascularised, de-epithelialised flap [4]. The attempt to generate a true composite bladder using cultured urothelium and muscle generated from their native source has been through animal and some clinical exposure but thus far have not gained widespread acceptance and usage – suggesting continued limitations [5, 6].

The pluripotent stem cell approach is attractive, as tissue can be generated from a source distant from the organ needing regeneration, thus bypassing any inherent disease process. The creation of an environment that pushes cellular differentiation along the desired path is the premise by which this works.

The authors of the current work [1] have analysed the population of generated cells using immunohistochemistry, scanning electron microscopy, gene expression analysis and Western blotting. From this we can learn that the cells are reproducible, viable and appear to exhibit characteristics of the desired smooth muscle cell. That said, all of the current models lack the most desirable of goals – that of controlled, functional similarity to the native bladder. The authors of this paper make the inference that the presence of α-smooth muscle actin suggests that the cells will be contractile. The experiments presented here may imply that but do not confirm it.

The field of tissue engineering remains exciting and authors such as these and others are to be congratulated on continuing to seek innovative approaches to solve a complex problem. The goal is organ replacement and clinical application. Each step along the path to that achievement is valuable but researchers working in the field need to ensure that they remain true to that aim. Cellular markers are only one part of a picture and future work must link them with function in novel cell populations. Once linked with function the means by which function is then controlled becomes important. Before we can safely apply this technology to patients, we must be clear about the functional abilities and limitations of the tissue created, this should be by evidence and not implication. Whilst those undertaking the research convey an optimistic view, the ability to understand the long-term viability and cellular stability remain significant unknowns.

Dan Wood
Adolescent and Paediatric Urology, University College London Hospitals, London, UK

Read the full article

References

  1. Verdi J, Shoae-Hassani A, Sharif S, Seifalian AM, Mortazavi-Tabatabaei SA, Rezaie S. Endometrial stem cell differentiation into smooth muscle cell: a novel approach for bladder tissue engineering in women. BJU Int 2013; 112: 854–863
  2. Biers SM, Venn SN, Greenwell TJ. The past, present and future of augmentation cystoplasty. BJU Int 2012; 109: 1280–1293
  3. Cross WR, Eardley I, Leese HJ, Southgate J. A biomimetic tissue from cultured normal human urothelial cells: analysis of physiological function. Am J Physiol Renal Physiol 2005; 289: F459–468
  4. Fraser M, Thomas DF, Pitt E, Harnden P, Trejdosiewicz LK, Southgate J. A surgical model of composite cystoplasty with cultured urothelial cells: a controlled study of gross outcome and urothelial phenotype. BJU Int 2004; 93: 609–616
  5. Oberpenning F, Meng J, Yoo JJ, Atala A. De novo reconstitution of a functional mammalian urinary bladder by tissue engineering. Nat Biotechnol 1999; 17: 149–155
  6. Atala A, Bauer SB, Soker S, Yoo JJ, Retik AB. Tissue-engineered autologous bladders for patients needing cystoplasty. Lancet 2006; 367: 1241–1246

A Rather Nasty Surprise

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Recently, I encountered, and indeed I actually caused, a complication of robot-assisted radical prostatectomy (RARP) which was new to me, and one which I felt that I should share with other surgeons.

PM, a 60-year old teacher, underwent a completely routine RARP, which took less than 2 hours to perform on a Saturday morning. During Sunday night he developed severe abdominal pain and distension. By Monday morning he was in distress with rebound tenderness and marked tachycardia. A CT scan was requested, which revealed a caecal volvulus. A laparotomy by a general surgeon confirmed the diagnosis and an urgent right hemicolectomy was undertaken. The patient made an uneventful recovery and, I am pleased to say, is still speaking to me. Histology confirmed an ischaemic caecum twisted on its rather thickened mesentery, with no perforation present. The prostate itself contained a Gleason 3+4=7 adenocarcinoma, without evidence of extra-prostatic extension.

Although robotic assistance provides the benefits of very precise, virtually bloodless surgery, with 10 times magnification and 3D vision, it also carries the risk of a specific set of complications. These need to be dealt with promptly and efficiently and can usually be completely resolved. Failure to recognise post-operative problems, such as bowel injury, intra-abdominal bleeding or port-site hernia, however, can place the patient in severe and increasing jeopardy. We recently published an article in the BJUI entitled “Lessons Learned from 1000 robot-assisted radical prostatectomy” in which we discussed how many of the problems could be avoided, and, if they occur how they can be best dealt with. One key message is the importance of an early CT scan to diagnose the nature of a post-operative problem, rather than crossing fingers and hoping things will settle.

I am hoping that this blog, and the BJUI article mentioned above, will stimulate other surgeons to discuss openly and frankly the problems that they themselves have encountered, either with regular laparoscopy or with the da Vinci robot, and how they dealt with them. Learning the lessons, not only from one’s own errors and omissions, but also from those of others, seems the best way to become, and continue to be, a safe and successful surgeon.  

 

Roger Kirby, The Prostate Centre, London

Technological Innovation in the BJUI

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Time waits for no man St. Marher, 1225

Urology is arguably the leading technology driven surgical specialty. This is no accident. As surgeons we have always looked towards minimal invasion to reduce the trauma of access to our patients. One would have thought that the advent of drugs for BPH and OAB would perhaps reduce our hunger for technology.You can visit One Click Power if you are always hungry for knowing trends in technology. On the contrary, many urologists have moved on to effective alternatives to TURP such as HoLEP and having learnt the lessons from previous unproven over enthusiasm, relied on the results of high quality randomised trials before accepting the results.

The BJUI has a long history of publishing innovative manuscripts in the fields of basic science, imaging and therapeutics. We aim to bring the readership entire new paradigms in surgical diagnostics and treatment. Indeed while we enjoy #ERUS13 in sunny Stockholm, the autumn sunshine reminds us of the role played by robotics in the steady rise of technological innovation. This “sub specialty” has become so prominent that the EAU are soon accepting ERUS and its committee as an integral part of the European Association of Urology. The randomised trials, meta analysis and health technology assessments are gradually appearing in contemporary literature such that it is no longer true to say that robotics is just a fad backed up by little or poor evidence. Robotics remains one of the most highly cited parts of the BJUI and therefore together with laparoscopy has its own dedicated section. We were pleased to publish the novel method of suprapubic catheterisation as an alternative to the urethral route after robotic prostatectomy [1] which led to much conversation on the BJUI twitter page. Our readers ultimately decide whether to adopt a particular technique or technology and are now able to vote via the BJUI Poll.

Last month, Mahesh Desai demonstrated microPCNL in London. The technology is truly breathtaking. It is hard to believe that light and image transmission as well as stone disintegration can be effectively achieved via a needle so thin! We almost stopped doing robotics and were thinking of re-training to become stone surgeons. Mahesh and his team went on to back up the technology with a randomised comparison against flexible ureterorenoscopy [2]. It should come as no surprise that such an article should come from the sub-continent where stone disease is endemic.

And the technological innovations in the BJUI continue. This month we present three rather different articles for your reading pleasure. The first is an international collaboration demonstrating the ideal dose and safety of photodynamic TOOKAD therapy (a light-activated vascular occluding agent) in localised prostate cancer. Nearly 80% of patients had negative biopsies at 6 months [3]. Next we evaluate the role of PET CT in bladder cancer patients undergoing cystectomy. With almost a 20% greater pickup than standard imaging, we may be able to save a number of patients a morbid operation in the presence of metastasis. Advanced imaging may also allow better stratification of patients for neo-adjuvant chemotherapy [4]. Finally, we have an exciting paper from Iran on the use of endometrial derived stem cells for creating bladder replacements and alternatives to meshes in prolapse surgery. The immuno and scanning electron micrographic images in this paper are just stunning [5].

The BJUI intends to continue leading technological innovation in urology. We will bring our readers early phase safety data on new technologies in addition to long-term results to truly judge their efficacy and durability. We hope you enjoy reading, citing and interacting with these articles online at bjui.org and ultimately translate them to your own clinical practice.

Prokar Dasgupta, Editor in Chief, BJUI
Ben Challacombe, Associate Editor, BJUI
King’s Health Partners

References

  1. Ghani KR, Trinh Q-D, Sammon JD et al. Percutaneous suprapubic tube bladder drainage after robot-assisted radical prostatectomy: a step-by-step guide. BJU Int 2013; 112: 703–705
  2. Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int 2013; 112: 355–361
  3. Azzouzi A-R, Barret E, Moore CM. TOOKAD® Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. BJU Int 2013; 112: 766–774
  4. Mertens LS, Fioole-Bruining A, Vegt E, Vogel WV, van Rhijn BW, Horenblas S. Impact of 18F-fluorodeoxyglucose (FDG)-positron-emission tomography/computed tomography (PET/CT) on management of patients with carcinoma invading bladder muscle. BJU Int 2013; 112: 729–734
  5. Shoae-Hassani A, Sharif S, Seifalian AM, Mortazavi-Tabatabaei SA, Rezaie S, Verdi J. Endometrial stem cell differentiation into smooth muscle cell: a novel approach for bladder tissue engineering in women. BJU Int 2013; 112: 854–863
Original publication of this editorial can be found at: doi 10.1111/bju.12431. BJUI 2013; 112: 707.

 

Clinicians and their cameras

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15 years ago, many people reading this blog won’t have even had a mobile phone! Fast forward to today and we wouldn’t leave home without it. Not content with just having a phone, we now crave the multimedia functionality of smartphones which dominate the market. With this ability to spread and share information so easily comes medico-legal dangers, not only for individuals but also hospitals concerned about patient confidentiality for which they are corporately responsible.

Not long ago, taking a picture of a medical condition for any purpose was a major effort. Contacting the medical photography department of the hospital would take an age and often the moment would be lost. Things began to change with affordable digital cameras although images were usually stored in one location on that camera, often locked away. This situation has altered completely with mobile phone now offering cameras capable of extremely high quality photography (I don’t own one but the Samsung Galaxy S4 possesses a 16MP lens offering far greater resolution than my digital SLR which is only a few years old and Nokia have just released a 41MP cameraphone!). Here you will get the brief idea about the wired vs wireless security system.  Suddenly if we see an interesting condition, we can whip our phones out, take a picture and immediately send it round the world on social media platforms. Even if the photos are just stored on the phone, with these being such desirable objects for thieves, this poses a significant risk to loss of that data and potential breach of patient confidentiality. It used to be that CCTV cameras were all that was required to ensure that things ran well in terms of security within a business. Tough circumstances, on the other hand, necessitate even harder measures, which necessitate the installation of detection and alarm systems. The fact that these commercial access control systems are available in a number of models is the nicest part about them.

So where am I going with this ? Well, I read with interest a recent article on “Clinicians and their Cameras” in Australian Health Review 2013. In this survey of one hospital in Australia, one fifth of clinicians reported using their personal mobile phones for medical photography. The authors describe as “endemic” the non-compliance with policy requirements for written consent for these images. Only 6% disposed of the images according to hospital protocol. What is scary is that I suspect the use of personal mobile phones may be under-reported!

There are many benefits to being able to immediately take a medical image in an appropriately consented patient. It may allow a condition to be tracked e.g. serial photographs of cellulitis; or allow discussion with a senior doctor where the most salient image e.g. the infected wound or an x-ray could even be sent to the consultant at home to review. These moments require spontaneity or the chance is lost.

Many hospitals, certainly in the NHS in the UK, completely ban the use of mobile phones for photography. This is an understandable corporate response to the problem which includes consent, confidentiality, appropriate use, storage and disposal.

Medical staff clearly need to be aware of the ethical issues and regulations regarding the use of medical images. The European Commission has found that collection of medical data and maintenance of medical records fall within the sphere of Article 8 of the European Convention on Human Rights. Thus failure to comply with regulations not only contravenes policy from your employer and regulatory body but also breaches the patients human rights. In the UK the Data Protection Act states that all organisations have a legal obligation to protect personal data which would include an individual taking images on any device and thus non-compliance also breaks the law.

The General Medical Council (GMC) in the UK has guidance on visual and audio recordings of patients. This makes clear the following points:

  • Appropriate consent must be obtained. This seems obvious although the guidance does say that separate consent is not necessary for images of internal organs, images of pathology slides, endoscopic images, x-ray and ultrasound images. These maybe used for “secondary purposes” without seeking consent if appropriately anonymised and non-recognisable. However this only applies if they are taken as part of the patient’s care. Images for research, teaching or training require appropriate consent which should be stored with the image.
  • All images should be anonymised/coded for storage. What mechanisms exist for this in your hospitals?
  • Images should be stored securely and follow local procedures and protocols. Fine in principal but how does this work in practice?
  • Recordings or images form part of the medical record. So if we do take an image we are responsible for ensuring it is accessible as part of the medical record.

But what about the unexpected finding in the middle of a case? The GMC guidance is clear: In this situation “you must not make recordings for secondary purposes without consent”. So you need it in advance if you are going to do it.

This study suggests that the use of mobile phones for photography in hospitals is commonplace and local protocols are not met. This is likely to be a widespread problem in hospitals in many countries. In my hospital the policy is clear: NO PHOTOGRPAHY ON PHONES OR PERSONAL DEVICES IN THE HOSPITAL. Any breach of this is a disciplinary offence. This prompted the following response from one of my colleagues: “This is ridiculous on many fronts. Bad for patient care, bad for education”. From a managerial perspective I can understand this. From a clinician’s point-of-view, I find this very sad with multiple opportunities lost for improving patient care and medical education. In a highly regulated workplace these rules are likely here to stay and we must all ensure we are compliant with them to avoid potential disciplinary action. I would be interested in the experiences and opinions of readers from other hospitals and countries.

Matthew Bultitude
BJUI Associate Editor

Editorial: Contemplate the template: a new prostate biopsy approach

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Transperineal magnetic resonance imaging – ultrasound fusion targeted biopsies (MRI-US FTB) of the prostate: the future of prostate diagnostics

The prostate cancer diagnostic pathway has remained unchanged for 25 years. At best, laterally directed, peripheral zone (PZ) 12-core transrectal biopsies identify cancer in 44% of cases [1] but transrectal biopsies have an inherent sampling error with a risk of misdiagnosis or mischaracterisation of disease. Of those with negative biopsies who undergo transperineal (TP) biopsies, 30% have cancer, most in the anterior PZ. Active surveillance and the promise of less invasive treatment options are becoming popular because of concerns about ‘over treatment’ for low-risk disease.

Saturation transrectal biopsies have been advocated to improve diagnostic yield but do not address the issue of under sampling of the anterior PZ, particularly in the larger gland [2]. TP biopsies can be used to address the issue of under sampling but prostate template-mapping biopsies are labour intensive and require large numbers of biopsies, often between 60 to 90 cores; however, they have been an essential component of focal therapy trials and the evaluation of novel treatment methods [3].

Primary TP biopsy is the subject of the paper published in this edition of the BJUI titled ‘Outcomes of transperineal template-guided prostate biopsy in 409 patients’ [4]. The authors report a single centre experience of primary TP biopsies. The 14-region protocol described is simpler than prostate template-mapping requiring fewer cores (median of 15 and mean of 19 cores) with a comparable primary diagnostic detection rate of 60% and an encouraging side-effect profile. Unfortunately, the approach still has limitations and the authors admit that their limited biopsy protocol may still mischaracterise disease in the larger gland. In a recent paper from the same group, there was a disappointing correlation between their TP biopsy pathology, MRI abnormalities and radical prostatectomy specimens [5]. Uncertainty prevails, the problem is how best to sample the larger gland. The authors [4] and others, often conclude that more biopsies are necessary for larger glands and resort to mapping protocols and many more biopsies. The solution may not be more biopsies but rather better systematic targeting of the PZ. The impact of hyperplasia within the transition zone (TZ) has a profound effect on PZ anatomy. In the smaller prostate, up to 30 mL, there is little TZ and the PZ is much thicker posteriorly than anteriorly, this difference is even more apparent in glands of 30–50 mL. Above 50 mL TZ expansion causes marked attenuation of the PZ, which becomes much thinner, but the overall volume of the PZ does not change. Less than 4% of cancers originate in the TZ [6], consequently biopsies should be concentrated primarily on the PZ.

The future of prostate cancer diagnosis is likely to be a combination of pre-biopsy multiparametric MRI, followed by targeted biopsies of MRI-identified lesions combined with fewer but better systematic targeted biopsies of the PZ. MRI-ultrasound (MRI-US) fusion techniques have been developed in which axial T2 images of the prostate, diffusion-weighted images and/or dynamic contrast-enhanced MRI images are ‘fused’ with the live US images to allow precise targeting of both regions of interest and the PZ. Commercially available biopsy programs, developed from brachytherapy software systems programs allow individual biopsy sites to be recorded and if combined with inking of the specimen can provide precise pathological localisation of disease within the prostate [7].

There are many potential benefits to this approach. Patients who opt for active surveillance will have an archived record of their disease at a given time to facilitate precise replication of further interval biopsies and assess progression. Improved disease management for an individual should be the aim. The suitability or not for focal or targeted therapies, the planning or boosting of identifed lesions with radiotherapy and/or brachytherapy, and the planning of nerve-sparing surgery or wide excisions should be possible. Feedback to the radiologists of both benign and malignant pathology and grade of disease will improve reporting accuracy and provide imaging sciences with the histopathological characteristics of both MRI ‘visible’ and ‘invisible’ cancer to improve MRI interpretation.

MRI–US fusion targeted biopsies are a significant advance in prostate diagnostics and may resolve some uncertainty within the prostate cancer diagnostic pathway. Benefit vs cost is a recurring issue across health care and questions will continue to be asked about the use of increasingly expensive technology in such an indolent disease. The challenge for investigators will be how to prove the benefit of this approach over standard biopsy protocols and integrate this work in to clinical practice.

Richard Popert
Department of Urology, Guy’s Hospital, London, UK

Read the full article
References
  1. Presti JC, O’Dowd GL, Miller MC et al. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol 2003; 169:125–129
  2. Stewart CS, Leibovich BC, Weaver AL, Lieber MM. Prostate cancer diagnosis using a saturation needle biopsy technique after previous negative sextant biopsies. J Urol 2001; 166: 86–92
  3. Onik G, Barzell W. Transperineal 3D mapping biopsy of the prostate: an essential tool in selecting patients for focal prostate cancer therapy. Urol Oncol 2008; 26: 506–510
  4. Symons JL, Huo A, Yuen CL et al. Outcomes of transperineal template-guided prostate biopsy in 409 patients. BJU Int 2013; 112: 585–593
  5. Huo AS, Hossack T, Symons JL et al. Accuracy of primary systematic template guided transperineal biopsy of the prostate for locating prostate cancer: a comparison with radical prostatectomy specimens. J Urol 2012; 187: 2044–2050
  6. Patel V, Merrick GS, Allen ZA et al. The incidence of transition zone prostate cancer diagnosed by transperineal template guided mapping biopsy: implications for treatment planning. Urology 2011; 77: 1148–1152
  7. Hadaschik BA, Kuru TH, Tulea C et al. A novel stereotactic prostate biopsy system integrating pre-interventional magnetic resonance imaging and live ultrasound fusion. J Urol 2011; 186: 2214–2220

Annual meeting of the Irish Society of Urology

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A wonderful ISU meeting in a stunning setting with exquisite weather in my home county, Wicklow.  Great talks and posters from our Residents, but it was the audience discussion they prompted that made this such a stellar meeting.  Tremendous senior academic input from the Members of the Urological Club of Great Britain and Ireland as well as Guest Speakers Ian Eardley from Leeds and Mike Naslund from the University of Maryland and BAUS President Adrian Joyce.  Excellent back and forth discussion on Surgical Training, Urological Emergencies, Prostate Biopsy Sepsis, Incidentalomas, creating Centres of Excellence for Testis and Penile Cancer and (of course!) the Search for the Truth About Robots.  

Basic Science topics were of a very high standard with Boyce et al promising a blood test of 4 proteins that was far better than the Partin tables!!  Professor Mike Naslund made the complex so simple for us to understand in his talk on Health Care Economics – the take home message being that when you create a system where the patient is not personally out of pocket in accessing health care, you cannot control the costs.  Ian Eardley spoke on “Men vs Health”, enumerated all of the increased risks to the male from Metabolic Syndrome and concluded with the premise that the specialty best suited to drive forth the Men’s Health agenda is Urology.  Most felt that it was one of the best meetings they had been to because it was all about common garden topics they encounter in everyday practice and not the esoteric topics that tend to dominate the larger meetings.  So, come mid-Atlantic in Killarney Co Kerry for the ISU 2014 Meeting on the 25th and 26th of September with Guest Speakers Craig Peters from the US and Prokar Dasgupta from the UK!!!!

 

Dr David Quinlan
Consultant Urologist, St Vincent’s Hospital,
Senior Lecturer, University College Dublin
Chairman, BJUI

Twitter: @daithiquinlan

Editorial: External validation of Karakiewicz models: do they hold up?

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Cancer-specific survival (CSS) in patients with RCC depends on important prognostic factors including specific clinical signs or symptoms, tumour-related factors and various laboratory findings. To better predict prognosis and aid patient counselling, several investigators have developed tools which have greatly enhanced our ability to predict outcomes in patients with RCC. For instance, Kattan et al. [1] have combined manner of presentation, tumour histology, tumour size and pathological stage to develop a nomogram that predicts cancer-free survival after nephrectomy. The stage, size, grade, and necrosis (SSIGN) score is another predominant model that provides individualized information for patients with clear-cell RCC. It incorporates the 1997 TNM stage, tumour size, nuclear grade and presence of tumour necrosis to predict recurrence and survival after radical nephrectomy [2]. The Karakiewicz nomogram [3] was developed to predict CSS based on multi-institutional data. The preoperative nomogram includes patient age, gender, clinical stage, presence of metastases, tumour size and symptom classification. The postoperative one includes TNM stage, tumour size, Fuhrman grade, histological subtype and local symptoms. Tan et al. [4] compared several prognostic systems (the Karakiewicz, Kattan and Sorbellini nomograms, and the Leibovich model) and concluded that in terms of individual counselling, the postoperative Karakiewicz nomogram is likely to be more useful than other models and provides excellently calibrated CSS estimates; however, before a prediction tool becomes popular in clinical use, it is crucial to perform internal and external validation to prove its generalizability. For example, the UCLA integrated staging system (UISS) helps to identify patients with localized or metastatic disease at low, intermediate, and high risk of disease progression and has been validated internally and externally [5].

The present study by Cindolo et al. [6] aims to assess the accuracy and generalizability of the pre- and postoperative Karakiewicz nomograms in predicting CSS. It is a retrospective study involving >3000 patients from multiple European and US centres between 1992 and 2010. They include high-, mid- and low-volume institutes, as well as different populations. This helps to provide a heterogenous study cohort to better reflect the real clinical situation and hence to improve the reproducibility of the nomogram. The preoperative and postoperative models have a good predictive ability with a stratified C-index of 0.784 and 0.842, respectively, and the latter discriminates substantially better. The authors conclude that the Karakiewicz nomograms proved to have excellent accuracy and generalizability.

With more RCC therapeutic options including surveillance, ablation, surgery and systemic therapies, better prediction tools are needed to help clinical decision-making. A wealth of literature now supports the hypothesis that nomograms and artificial neural networks are superior to classic TNM staging systems in risk assessment; therefore, these predictive tools are important to guide the counselling, treatment and follow-up of patients with RCC.

Peggy Chu1 and Ringo Wing-Hong Chu2
1Department of Surgery, Tuen Mun Hospital, and 2Department of Surgery, Kwong Wah Hospital, Hong Kong, China

Read the full article
References
  1. Kattan MW, Reuter V, Motzer RJ et al. A postoperative prognostic nomogram for renal cell carcinoma. J Urol 2001; 166: 63–7
  2. Frank I, Blute ML, Cheville JC et al. An outcome prediction model for patients with clear cell renal cell carcinoma treated with radical nephrectomy based on tumor stage, size, grade and necrosis: the sign score. J Urol 2002; 168: 2395–400
  3. Karakiewicz PI, Briganti A, Chun FK et al. Multi-institutional validation of a new renal cancer-specific survival nomogram. J Clin Oncol 2007; 25: 1316–22
  4. Tan MH, Li H, Choong CV et al. The Karakiewicz nomogram is the most useful clinical predictor for survival outcomes in patients with localized renal cell carcinoma. Cancer 2011; 117: 5314–24
  5. Cindolo L, Chiodini P, Gall C et al. Validation by calibration of the UCLA integrated staging system prognostic model for nonmetastatic renal cell carcinoma after nephrectomy. Cancer 2008; 113: 65–71
  6. Cindolo L, Chiodini P, Brookman-May S et al. Assessing the accuracy and generalizability of the preoperative and postoperative Karakiewicz nomograms for renal cell carcinoma: results from a multicentre European and US study. BJU Int 2013; 112: 578–584.

Editorial: LESS versus laparoscopic nephroureterectomy: the winner is…

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In this international multi-institutional study, Park et al. [1] have retrospectively collected and analysed data about 101 patients who underwent laparoendoscopic single-site (LESS) nephroureterectomy (NU) for upper urinary tract (UUT) urothelial carcinoma.

Nowadays, NU represents the standard of care for the surgical treatment of UUT urothelial carcinoma in the majority of patients [2]. Outcomes of such an intervention are strongly improved when lymph node dissection (LND) is performed according to a well-defined template [3].

In recent years, laparoscopy has become an important new approach to reduce the invasiveness of the surgical treatment of UUT urothelial carcinoma. In a multicentre Italian study Porpiglia et al. [4] showed that laparoscopic NU with open ureterectomy was a feasible and safe technique. Oncological results seemed to be similar to those of the traditional open approach, but the laparoscopic approach still has some disadvantages. First, patients who undergo a laparoscopic procedure receive LND with lower frequency. Moreover, the template during a laparoscopic procedure is rarely respected and the number of lymph nodes removed is often suboptimal [3]. Second, there is no consensus in the literature about the pathological stages that could potentially benefit from the bladder-cuff excision step of this procedure [5]. Bladder-cuff excision omission does not seem to undermine survival in patients with low-stage (pT1-2) disease, nevertheless confirmatory recurrence data are required before a NU without bladder-cuff excision may be considered as an option for this patient category.

The present paper shows that advances in surgical technology are being made, but it also underlines the fact that the above-mentioned disadvantages of NU are still under discussion, and these disadvantages are expanded when introducing a newer and challenging technique such as the LESS approach.

In the present study, different devices and instruments were used. Furthermore, the rate of LND reported was very low (27%), as the number of lymph nodes removed (approximately five). LND was often ‘formally’ performed, and no specific template was reported to be used. Bladder-cuff excision was not performed in 20% of cases and, when performed, the technique used was not clearly defined. With regard to oncological efficacy, the recurrence rate of 22% at 11 months is not sufficient to clarify if the LESS approach is oncologically effective [6].

In summary, there are evident limitations to the present paper; some are methodological, such as its retrospective nature and the non-homogeneous datasheets used to collect data, and some are technical and oncological. These limitations are justified by the fact that the technique is in its embryonic stages. Nevertheless, the authors deserve praise for having collected such a large number of cases for their study on LESS NU. Their paper underlines the fact that this technique is feasible and safe, and each surgeon who contributed by insisting on such a challenging and novel approach to NU should be congratulated for their efforts.

Now that the feasibility of the LESS NU technique has been demonstrated, the authors have the task of clarifying whether introducing a LESS approach would or would not compromise oncological outcomes. In any case, it is recommended that surgical oncological principles be respected when a new technique is introduced, especially when dealing with a high-risk cell-seeding tumour such as urothelial carcinoma.

Francesco Porpiglia and Riccardo Bertolo
Department of Clinical and Biological Sciences, San Luigi Hospital, Division of Urology, University of Turin, Orbassano-Turin, Italy

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REFERENCES
  1. Park SY, Rha KH, Autorino R et al. Laparoendoscopic single-site nephroureterectomy for upper urinary tract urothelial carcinoma: outcomes of an international multi-institutional study of 101 patients. BJU Int 2013; 112: 610–615
  2. Rouprêt M, Zigeuner R, Palou J et al. European guidelines for the diagnosis and management of upper urinary tract urothelial cell carcinomas: 2011 update. Eur Urol 2011; 59: 584–594
  3. Roscigno M, Brausi M, Heidenreich A et al. Lymphadenectomy at the time of nephroureterectomy for upper tract urothelial cancer.Eur Urol 2011; 60: 776–783
  4. Porpiglia F, Celia A, Luciani L, Terrone C, Guazzoni G, Parma P. Laparoscopic radical nephroureterectomy: results of a multicentric italian study. J Endourol 2009; 23 (Suppl. 1): A109
  5. Lughezzani G, Sun M, Perrotte P et al. Should bladder cuff excision remain the standard of care at nephroureterectomy in patients with urothelial carcinoma of the renal pelvis? A population-based study. Eur Urol 2010; 57: 956–962
  6. Walton TJ, Novara G, Matsumoto K et al. Oncological outcomes after laparoscopic and open radical nephroureterectomy: results from an international cohort. BJU Int 2010; 108: 406–412

UroLift Takes Off From Down Under. The Potential Rewards When Engineers Bring You Into Their Inner Circle

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At the American Urological Association meeting in San Antonio in May 2005, I was introduced to a four engineers from a small start up company called NC2 (New Company 2).  It had at that time been recently spun off from the medical device incubator company Exploramed.  They had no product and not even a prototype of a product that could possibly be used in humans but what they did have was a passion to make a difference, incredible ideas and a laptop computer. 

They had thought about the failings of existing mechanical treatments for LUTS/ BPH and the first that comes to your mind is prostatic stents.  No stent conforms perfectly to the shape of the prostatic urethra and there were the issues of encrustation of any elements of stent material that were exposed to the urine.  Rather than throw the baby out with the bathwater, they harnessed what was good about stents, which was the potentially immediate effects they could have on urinary function without associated destruction of tissue and that perhaps tailoring the radial expansion to just a few critical points rather than the entire length of the prostatic urethra could do the trick.

The original idea was that some sort of metallic disc could be placed outside the prostate capsule and one on the urethral side and between them, a non absorbable suture could be placed under tension and therefore draw open the prostatic urethra and defined sites.  How these engineers were to find a way of designing a delivery tool to do this had me a little skeptical at first but there seemed to be no doubt in their minds, even thought they had not yet worked it out, were going to find a way.  Their confidence, intellect and enthusiasm was infectious and you just felt like you wanted to be a part of this project.  It so turned out that the metallic discs would be replaced by linear metallic tabs which logically make for easier delivery.

So why involve Australians?  It is difficult to keep things under the radar and one way of doing so is to take the idea where it is less likely to be visible. Additionally, the data needed to be trustworthy and in a place where strong ethic committee governance structures exist. We make no illusion that for once, being Australian, gave us a clinical research opportunity from a company based in the US that would rarely be directed our way.

My Australian colleague, Dr Peter Chin was also brought in on the project.  Over the next few months, we did not hear anything but there was then an urgent call that ‘California was the place we ought to be’ so we literally dropped everything and headed over to Silicon Valley where we had the opportunity to use the first prototype of the device on human cadavers.  Whilst our travel costs were covered by NC2, we received no payment for our time spent during these exercises but remuneration was the last thing on our minds given the exciting path that the idea could potentially take.  Simultaneously, animal studies were being conducted and these demonstrated that the internal metallic tabs of the prosthesis would become covered by urothelium and in combination with the cadaveric work, provided a convincing argument to move forward with human clinical trials.

Putting on a brave face doing the first human Urolift case at Westmead Hospital in Sydney in December 2005

By December 2005, we were ready to conduct the first human trials.  We measured everything that could possibly move and it probably took close to 2 hours to perform the first case.  The initial prototype device used looked like it was literally built in somebody’s garage workshop but it was functional and confirmed proof in principle that a transurethral delivery system could deploy metallic tabs on the capsular side of the prostate and within the urethra that was connected by a tensioned suture. Through this, it created mechanical alteration to the anatomy of the prostatic urethra with positive influence on lower urinary tract symptoms.  From here, multiple clinical trials have been performed by the company that became known as Neotract Inc and as of 13 September 2013, the device received FDA approval.

It is enormous privilege to have played a role in product development from inception of an idea through to FDA approval.  These opportunities are rare and whilst healthy skepticism and caution should be applied to all ideas presented to you, if you are offered such an opportunity to take a side project, it could be a rewarding diversion from your daily clinical practice.  Financially, you will never recoup your time investment but the rewards of making a difference is priceless.

Shared passion for a project can go a long way.   This experience emphasizes the value of engineers interacting with clinicians to achieve a desired outcome and there is certainly room for of such interactions. Opportunities to embrace these relationships are out there and perhaps a good place to start is to become active in the Engineering and Urology Society which as a section of the Endourological Society meets each year at the AUA Annual Meeting.

 

Henry Woo is an Associate Professor of Surgery at the Sydney Adventist Hospital Clinical School of the University of Sydney in Australia. He has been appointed as the inaugural BJUI CME Editor. He is currently the coordinator of the International Urology Journal Club on Twitter. Follow him on Twitter @DrHWoo

Disclosure: Henry Woo has formerly been an investigator and advisor to Neotract Inc. He holds a small stock investment in the company.

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