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Editorial: Somatic-autonomic neurorrhaphy for erectile function restoration after radical prostatectomy

The authors of the present study [1] are to be commended for their efforts in describing their 3-year experience with a novel bilateral end-to-side somatic-autonomic neurorrhaphy intended to restore erectile function at least 24 months after radical prostatectomy, after which spontaneous return of erectile function is unlikely [2]. Using the principles of brain plasticity and neurotization, the authors describe, for the first time, bilateral sural neurografting between the femoral nerve and both the corpus cavernosum and the dorsal nerve of the penis to achieve penile re-innervation. The employed side-to-end neurorrhaphy theoretically limits functional damage during axonal sprouting, reinforces sensory–motor communications to the cavernous nerves, and promotes glans penis sensitivity, although direct evidence of these physiological and clinical outcomes is yet to be demonstrated. Furthermore, the authors astutely capitalize on the potential advantages of using a femoral donor nerve, including its proximity to the proximal penis, its diameter, the sufficient axon count, the mixed composition of sensory and motor fibres, and its secretion of acetylcholine which is an essential neurotransmitter in the nitric oxide-mediated pathway leading to penile tumescence.

What is especially singular about this technique is its application months after radical prostatectomy following demonstrated post-surgical loss of erectile function. Previous studies have focused on unilateral or bilateral sural [3-6] or genitofemoral [7] neurografting of the cavernous nerves at the time of radical prostatectomy before post-surgical loss of erectile function could be substantiated. Such studies have had mixed results, attributable in part to the success of the nerve-sparing radical prostatectomy technique in the hands of experienced high-volume surgeons [3, 6], and post-surgical exposure of the cavernous nerves to androgen deprivation or radiation therapy in some patients [3, 5]. Whereas post-radical prostatectomy re-innervation of the cavernous nerves may not be feasible or efficacious secondary to post-surgical and post-radiation fibrosis, the described technique does not require abdominopelvic access, is associated with a quick recovery time and minimal complications, and does not preclude subsequent penile prosthesis implantation if necessary.

The results of the present study show significant improvement in general sexual satisfaction from baseline to 6 months post intervention corresponding to achievement of flaccid erection for all patients; significant improvement in erectile dysfunction from baseline to 12 months post intervention corresponding to achievement of semi-rigid or rigid erections in 8/10 patients; and significant improvement in satisfaction with sexual intercourse from baseline to 18 months post intervention corresponding to achievement of penetration for 6/10 patients. It should be noted, however, that administration of the Clinical Evolution of Erectile Function instrument at 36 months postoperatively may have introduced recall bias in patient-reported erectile function. As would be expected, no significant differences were noted in sexual desire or orgasm satisfaction during the study period. These results were achieved without evidence of atrophy, fibrosis, or significant differences in vascular flow of the bilateral corpora cavernosa; and with minimal complications over the study period.

The present study provides preliminary data regarding the safety, feasibility and efficacy of bilateral sural neurografting between the femoral nerve and both the corpus cavernosum and the dorsal nerve of the penis to restore post-radical prostatectomy erectile function in a limited pool of 10 men. If these preliminary results are substantiated with long-term follow-up in a significant number of patients, it should prompt multi-institutional collaborations to appropriately power comparative effectiveness analyses of post-radical prostatectomy neurorrhaphy, such as the described technique to a regulatory-approved ethical sham intervention, vacuum assist device therapy, urethral suppository therapy, or intracavernosal injection therapy. Ideally, patients should be matched or statistical analyses should be controlled for patient age, relevant comorbidities, prostate cancer stage, pre-radical prostatectomy erectile function, nerve-sparing radical prostatectomy technique, androgen deprivation therapy, radiation therapy, response to phosphodiesterase-5 inhibition, and time interval between radical prostatectomy and intervention. Such multi-institutional studies would benefit from: standardized protocols for preoperative evaluation, operative technique, peri-operative care and post-surgical sexual stimulation; repeated-measure analyses of both objective assessments of the quality and duration of penile tumescence, as well as patient-reported outcomes of erectile function and disease-specific quality of life using validated instruments; report of oncological outcomes; and long-term follow-up. We would encourage the authors to produce a technical video demonstrating their technique so that it may be attempted and validated by other programmes. Urological surgeons with expertise in oncology, sexual function, and reconstruction may collaborate and pool patient data to achieve high-powered quality studies of novel techniques, such as the one described in the present study, for post-radical prostatectomy erectile function restoration.

Jaime A. Cavalloand Ashutosh K. Tewari, Chairman
Milton and Carroll Petrie Department of Urology, Icahn School of Medicine at M ount Sinai, New York, NY, USA

 

How to Cite

Cavallo, J. A. and Tewari, A. K. (2017), Somatic-autonomic neurorrhaphy for erectile function restoration after radical prostatectomy. BJU International, 119: 816–818. doi: 10.1111/bju.13858

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Editorial: Celebrating BAUS and NICE Guidance

On behalf of the BAUS Council, I am delighted to write this editorial looking forward to the 73rd annual meeting of the BAUS, which will be held in Glasgow from 26 to 28 June. In response to feedback we had from delegates following BAUS 2016 and the successful European Association of Urology meeting in London this March, we have changed the format and duration of the meeting, ensuring that it has a distinct feel, reflecting the best of British Urology.

With Brexit looming and the precarious state of NHS finances, the continuing challenge for all of us working in the NHS is to deliver high-quality care within available resources, while embracing the latest evidence informing clinical practice. This month’s BJUI sees the first publication of National Institute for Health and Care Excellence (NICE) guidance on urological topics – ‘MTG29 GreenLight XPS for treating benign prostatic hyperplasia’ [1]. NICE has a fantastic track record in publishing highly regarded evidence-based syntheses across the breath of medicine and this guidance will stimulate the development and adoption of Greenlight laser for treating BPH as a day case procedure in the UK.

Assessing and critiquing new evidence are key elements of the annual BAUS meeting and this year is no exception. In all, 535 abstracts were submitted of which 157 will be presented. Whilst much of our clinical practice is of a high quality, analysis of the work done by the ‘Getting it right first time’ (GIRFT) team has shown a wide variation in practice for many common conditions in Urology. Simon Harrison, who leads the GIRFT team, will be giving an update on the progress of the work in a session looking at how standards can be applied in the real world at a session on Tuesday 27 June, entitled ‘Urology standards and the real world’.

On Monday 26 June, Academic Urology, Andrology and Genito-Urethral Surgery (AGUS), and Female, Neurological and Urodynamic Urology (FNUU) will be holding their annual meetings. State of the art lectures include Professor Trinity Bivalacqua speaking on ‘Molecular genetics and the prospect for future treatment strategies in Urology’. The AGUS section will focus on the genital emergencies consultation and the future of andrology in the UK, shedding light on specialist commissioning and training in the speciality. Highlights of the FNUU section meeting will include an update on meshes and tapes and the medicolegal consequences of adverse outcomes.

British urology has played a pivotal role in our understanding of the diagnosis and management of prostate cancer. Reflecting this, a point-counterpoint debate will take place on Tuesday 27 June, with Caroline Moore and Paul Cathcart debating the necessity for prostate biopsy in patients with Prostate Imaging Reporting and Data System (PI-RADS) 1and 2 lesions seen on MRI, drawing on evidence from the recent PROstate MRI Imaging Study (PROMIS) trial. On Wednesday 28, Noel Clarke will report on the latest news from the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE) study, which to date has recruited >9000 patients. New evidence from the study is likely to herald a change in the care of our patients with metastatic prostate cancer.

In addition to state of the art papers, we are delighted to have a number of key opinion leaders attending the meeting. Reflecting the public’s high expectations and pressures on clinicians, Professor David Speigelhalter, Winton Professor for the Public Understanding of Risk at the University of Cambridge, will speak on the nature of risk and uncertainty in clinical practice. The BJUI Guest lecture will be delivered by David Prior (Parliamentary Under Secretary of State in the House of Lords). With the recent publication of The Long-term Sustainability of the NHS and Adult Social Care report [2], he is uniquely placed to give a perspective on the future direction of the NHS.

For the first time at our meeting there will be a session entitled ‘When things go wrong’. This session will focus on the impact of adverse events and burnout on Urologists, which promises to be insightful and thought provoking. With plenty of science, innovations in urological care and some politics, BAUS 2107 promises to be a fascinating meeting. I look forward to seeing you there.

Kieran OFlynn

 

President of the BAUS

 

Read the full article

How to Cite

O’Flynn, K. (2017), Celebrating BAUS and NICE Guidance. BJU International, 119: 815. doi: 10.1111/bju.13899

 

References

1 National Institute for Health and Care Excellence.MTG29 GreenLight XPS for treating benign prostatic hyperplasia.BJU Int 2017;119:82330

 

2 House of Lords.The Long-term Sustainability of the NHS and Adult Social Care, 5 April 2017. Available at: https://www.publications.parliament.uk/pa/ld201617/ldselect/ldnhssus/151/151.pdf. Accessed 24 April 2017

 

Editorial: Oestrogen redux: will transdermal delivery rebalance the risk–benefit equation?

Between 1960 and 1975, the Veterans Association Cooperative Urological Research Group (VACURG) conducted a series of large randomized trials to test several oestrogenic compounds in varying doses and combinations with regard to their efficacy and safety in the treatment of all stages of prostate cancer [1]. The major message conveyed by these trials was the significant cardiovascular morbidity and mortality associated with 5 mg of oral diethylstilbesterol and the adverse impact on overall survival. Much less attention was given to the cancer-specific survival in the oestrogen arms of the study, which prompted the trial statistician to attribute the favourable effect of oestrogen to testosterone-lowering as well as to a direct cytotoxic effect. One half-century later clinical trial investigators in the UK are reevaluating the therapeutic utility of oestrogen delivered via a transdermal rather than an oral route to address and challenge some of the major conclusions of VACURG. The PATCH (Prostate Adenocarcinoma: TransCutaneous Hormone, MRC, PR 09) trial is an ongoing randomized trial comparing transdermal oestrogen with LHRH analogues in men with advanced prostate cancer. Among the critical endpoints will be overall survival, cancer-specific survival, PSA progression and quality of life. Castrate levels of testosterone have been achieved more rapidly in the transdermal oestrogen arm, there is no testosterone flare, and dose escalation may further improve on the 92–93% of patients reaching castrate levels of testosterone. Trial data published thus far have shown that transdermal oestrogen has a significant advantage with regard to maintaining bone health [2].

In the present issue of BJUI, Gilbert et al. [3] address quality-of-life outcomes for 700 patients, representing > 80% of the study cohort, who submitted pre-treatment and 6-month post-treatment questionnaires. For all ages, 6-month global quality of life declined in both arms, but to a statistically lesser extent in the transdermal oestrogen arm compared with the LHRHa arm. There was also a statistically lesser decline in physical function and fatigue and sexual interest with transdermal oestrogen. Sexual interest decline was more pronounced for men aged < 70 years. As expected, hot flashes were significantly lower with transdermal oestrogen and were responsible, along with associated sleep disturbances, for a significant component of the quality-of-life decline in the LHRHa arm. Also, as expected, gynecomastia was more frequent with transdermal oestrogen but was associated with a decline in quality of life only in a small minority (8%) of patients who reported ‘very much’ gynecomastia. Only two patients underwent surgery for gynecomastia. For the small percentage of men for whom gynecomastia/dynia is problematic, more frequent employment of subcutaneous mastectomy could be of benefit. The acceptance of gynecomastia is likely to be quite different between cultures and countries.

The finding that sexual interest was improved in the transdermal oestrogen arm is substantiated by clinical trials specifically investigating the role of oestrogen in male sexual health. Both oestrogen and testosterone are necessary [4]. Endogenous oestrogen in men is derived from testosterone through aromatization. The absence of testosterone translates to the absence of oestrogen. It is beneficial to be only mono-hormone-deprived (testosterone) rather than dual-hormone-deprived (testosterone and oestrogen). Additional benefits associated with oestrogen in the male have been reviewed by Wibowo et al. [5].

The previously reported bone health advantage and the current quality-of-life data would appear quite convincing in favour of transdermal oestrogen as a preferred or at least an alternate option for androgen deprivation therapy; however, the association of oestrogen with cardiovascular toxicity has presented a major hurdle. Interestingly, Byar and Corle [1] noted that on initial publication of the cardiovascular morbidity data, physicians were not convinced and were resistant to changing their support of oral diethylstilbesterol therapy. Today, however, the mindset is the polar opposite: a conviction that oestrogen will expose patients to unacceptable cardiovascular morbidity. However, transdermal delivery, which avoids the enterohepatic first pass through the liver circulation, bypasses the coagulopathies associated with oral oestrogen. A previous report from PATCH confirmed that, with 19-month follow-up there is a similar rate of cardiovascular events between the transdermal oestrogen and LHRHa arms [6].

Finally, my favourable drift in this summary is based on personal bias that warrants disclosure and explanation. When my prostate cancer became castration-resistant 8 years ago, LHRHa androgen deprivation therapy was replaced by transdermal oestradiol. My impression that the progression to metastatic castration-resistant prostate cancer was slowed is subject to debate, but my quality-of-life improvement is not. I say this with some degree of confidence, based on cycling between the two agents. Initially on switching to transdermal oestradiol from LHRHa I ‘felt better’. Entry into a subsequent clinical trial required discontinuation of oestrogen and replacement with LHRHa. I regressed, and ‘felt worse’. On completion of the trial I discontinued LHRHa, resumed transdermal oestrogen and ‘felt better’ once again.

In moving the needle back to the old so that it becomes new again, we are faced with a difficult mindset hurdle. In the case of transdermal oestrogen, I feel, based on quality of life and even perhaps a survival benefit, it is a hurdle well worth exploration.

Read more articles of the week

How to Cite

Schellhammer, P. F. (2017), Oestrogen redux: will transdermal delivery rebalance the risk–benefit equation?. BJU International, 119: 653–654. doi: 10.1111/bju.13737

References

 

 

 

 

4 Finkelstein JS, Lee H, Burnett-Bowie SM et al. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med 2013; 369: 101122

 

 

 

Editorial: The BPH6 study raises the bar on how we should conduct BPH surgical trials

We have all done it. We’ve all shaken our heads with bemusement when men have severe symptoms, as would be defined by the IPSS, yet their response to the quality-of-life question would either be ‘delighted’ or ‘satisfied’. Likewise, we may see men who have objective multiple-fold improvement in their urinary flow rates after a BPH surgical procedure but are more unhappy about their urinary function than they were with their preoperative state. Such mismatches in clinician and patient expectation are not uncommon in clinical practice and are likely, in part, to be a reflection of what measurements clinicians and patients consider to be of importance.

The BPH6 study has challenged the traditional way in which the success of a surgical treatment has been assessed [1]. When prostatic urethral lift (PUL) was compared with TURP in the setting of a randomized controlled trial, there was clearly superior performance of the former as highlighted by a patient-centred outcome metric referred to as the BPH6. It could be argued on the one hand that the combined metric games the outcome in favour of PUL, given that known shortfalls in TURP outcomes, such as recovery, sexual dysfunction and morbidity, could not see it fairly compete with a minimally invasive surgical treatment, but, on the other hand, perhaps the BPH6 metric is just measuring what matters to our patients. The BPH6 is made up of variables that are not in any way new and have all either been established or validated ways of measuring outcomes. A valid criticism, however, is that the combined BPH6 metric is yet to be validated.

Gratze et al. [2] report the 2-year results of the BPH6 study, in a paper that is a great deal more than just a progress report. It represents the most comprehensive patient-centred outcome and quality-of-life assessment ever performed on BPH surgical procedures. Their study also introduces several patient-centred outcome measures that were not reported in the 1-year publication. Additional to the now already well-described BPH6 variables, the study includes the Patient Global Impression of Improvement (PGI-I), the Short-Form Health Survey (SF-12) with its derivative SF-6D utility score, the minimal clinical important difference (MCID) and the Jenkins Sleep Questionnaire.

The PGI-I is perhaps the true test as to what a patient thinks about the effectiveness of a surgical procedure. There is no ambiguity about a response to a direct question as to whether a patient perceives a treatment to have improved or worsened their condition. Whilst the origins of the PGI-I are in the non-urological literature, it has recently been making its way into BPH clinical studies [3, 4]. This should be encouraged and we should indeed dare to ask our patients whether they consider our treatment has lead to improvement or otherwise.

The MCID has been used extensively in the medical literature since its introduction in 1989 [5]. The BPH6 study is the first clinical trial on BPH surgical treatment to use this metric. The MCID is exactly as the term is defined, and is assessed across a range of measures in the paper by Gratze et al. in the context of quality of life. A literature search will reveal that urologists have been very late to the party, but this study will probably have a role-modelling effect with regard to the future use of the MCID in health-related quality of life assessments in BPH studies.

The BPH6 study raises the bar for how we should measure the full impact of the surgical treatment of BPH. There has never been a clinical study that has explored patient-centred outcome measures and quality of life after surgical treatment of BPH to an extent that is even remotely close to that reported here. Whether the combined BPH6 metric becomes popularized or not is less important than the fact that future clinical trials will undoubtedly see an adoption of patient-measured outcomes. Such measures could play an increasingly important role in the decision process for health funders to support a new or existing treatment as well as assist patients in understanding the trade-off between the negative and positive impacts of treatment. We can expect to see plenty of future work that will attempt to verify these assertions.

Read the full article

How to Cite

Woo, H. H. (2017), The BPH6 study raises the bar on how we should conduct BPH surgical trials. BJU International, 119: 654–655. doi: 10.1111/bju.13815

Henry H. Woo
Sydney Adventist Hospital Clinical School, University of Sydney, Sydney, NSW, Australia

 

References

 

 

Editorial: The ATOMS… Is it really all so easy?

The adjustable transobturator male system (ATOMS® Agency for Medical Innovations A.M.I., Feldkirch, Austria) is an interesting device (the design is evocative of the historical Kaufmann sling) that is now incorporated into the wide spectrum of post-prostatectomy incontinence treatments, and which confirms the real existing pathology despite the introduction of optimised robot-assisted prostate surgery. An interesting article in the present issue of BJUI describes the long-term outcome of the ATOMS device [1].

But there are some considerations that I would like to raise about this device. Only the first generation of ATOMS (inguinal port, IP) has long-term follow-up data and 15% of implanted devices have been explanted within 6–33 months [2]. So, I think we have to be prudent and wait for further long-term results for the third-generation silicone-covered scrotal port (SSP) system, as it has only 2–7 months of previously published outcome data.

As the explantation rates of all other silicone devices are still high, between 12% and 35% in the mid- to long-term, why should we not expect this for the ATOMS SSP third generation? All devices (sphincters, Argus, Reemex etc.) have an explantation risk and the causes are, in most cases infections and erosions, i.e. still trophic problems.

As stated, the explant rate of silicone devices is still high, but the removal of silicone parts is relatively easy because of the ‘coating’ by a collagenous capsule. On the other hand, male slings (mesh) are really rarely infected and require explantation, but if this happens a complete removal of the transobturator tape (TOT) male mesh sling is needed, which is still relatively challenging surgery and incapacitating for the patient, especially if the mesh has become ingrown.

Another point in the study of Friedl et al. [1] is that titanium intolerance is described as one of the main causes of device explantation (41%). We have to consider the broad use of titanium-covered meshes or titanium artificial hips, as in the literature prosthesis explantation caused by titanium intolerance have not been reported at such high percentages. It thus seems unlikely that titanium intolerance should be the problem rather than trophic or mechanical factors leading to erosion (41% of ATOMS explants in long-term follow-up [1]).

Lastly, we know that patients with minimal and moderate incontinence can be treated successfully by a simple tissue-fixed TOT sling. Patients with more intrinsic sphincter deficiency, with repeated anastomotic incisions or resections need a more compressive device, and compression needs adjustability over time, a field for devices such as Argus and Reemex for example. Also at night time, patients with incontinence (real and severe intrinsic sphincter deficiency) need an artificial sphincter for continence and good unobstructed voiding (on/off). So which group of patients should be targeted for this combination between a hydraulic-filled balloon, adjustable subcutaneous port and TOT sling, as 60–70% of patients with mild-to-moderate incontinence are dry using the sling alone [3]. Should it be the first choice for all non-irradiated patients? or for those that have TOT failure? Or artificial sphincter failure? Or intrinsic sphincter deficiency? Therefore, what we need to clarify is the real indications for this combined tri-component device (silicone port, silicone balloon and TOT mesh). And we must also not forget that there could be atrophy of the membranous urethra due to the bulking effect of the silicone balloon. This is another point that has to be considered.

In the treatment of male incontinence we must focus not only on the effectiveness but also on the safety of the device used. This is particularly important considering the warning issued by the USA Food and Drug Administration (FDA) for female mesh slings.

Read the full article

How to Cite

Gozzi, C. (2017), Considerations about the adjustable transobturator male system (ATOMS®) device… is it really all so easy?. BJU International, 119: 655–656. doi: 10.1111/bju.13830

 

Christian Gozzi
Department of Urology, Marienklinik, Bolzano, Italy

 

References

 

 

The British are coming!

bju13868-fig-0001Historians report that Paul Revere never said these famous words; as Colonial Americans at the time still considered themselves British. Indeed, Americans still consider themselves European. The United States Census reports that 73% of Americans are of European descent, and 62% of these are of English, Scottish, Welsh or Irish ancestry.

These links to our heritage remain strong. With >1100 European members (close to 200 from the UK) and >300 members from Australia and New Zealand, our bonds of friendship and collaboration are tightly intertwined. So if Paul Revere won’t say it, I will!

The British are coming! Each year >2000 Europeans attend our Annual meeting (200 from the UK) and >100 from Australia and New Zealand. They are represented not only in quantity but also in quality. Of the 1700 scientific abstracts submitted from Europe to the 2017 Annual meeting, the acceptance rate was 38% for the UK, compared to an overall acceptance rate of 34%. Important science comes from the UK and Australia, and raises the quality of our meeting.

The BAUS–BJUI–USANZ Joint Session on Sunday 14 May in Boston is a clear example of how the BJUI family, as the official journal of the USANZ and the BAUS ‘raises the bar’ at the AUA Annual Meeting. With focuses on personalised medicine, genomics, systems biology, immunotherapy, and ‘training the brain’, it promises to stimulate and educate. Following this we look forward to toasting our transatlantic brothers and sisters with a Boston Lager at the BJUI reception.

The British are coming! We look forward to welcoming you in Boston in May.

Manoj Monga, AUA Secretary
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA

 

Editorial: Is there a role for pure clinical prediction models in prostate cancer in the contemporary era?

The identification of men with localised prostate cancer at higher risk of adverse pathological outcomes after radical prostatectomy (RP) would assist physicians in preoperative patient counselling and in tailoring the most appropriate treatment strategy. In this issue of the BJUI, Tosoian et al. [1] have updated the Partin Tables in contemporary patients with localised prostate cancer. The authors should be commended for undertaking a well-performed study evaluating a large cohort of patients treated at a high-volume centre. Notably, they were able to show that the Partin Tables still represent an accurate tool for identifying men at higher risk of adverse pathological features [1]. Having said this, the first question we should ask ourselves is whether preoperative models based on clinical variables only still play a role in contemporary patients. The Partin Tables were developed in 1993 and since then they have undergone a series of updates, all of which are based on virtually the same variables included in the original analyses [1]. However, recent implementations, including biomarkers and imaging, have been introduced to better stage prostate cancer. These novel approaches are usually added to clinical variables to improve patient risk stratification. Multi-parametric MRI (mp-MRI) represents the major game changer in this setting, being now recommended for prostate cancer staging in all men with high-risk disease and in those with less favourable intermediate-risk prostate cancer [2]. In the era of modern and sophisticated approaches, are models using clinical variables only still clinically valuable? To answer this question, we can consider two major settings, namely nodal and local staging.

When assessing the risk of lymph node invasion (LNI) at diagnosis, mp-MRI and positron emission tomography/CT scan are characterised by a low sensitivity and, therefore, are not recommended for the identification of patients who should receive a lymph node dissection (LND) [2, 3]. Conversely, the updated Partin Tables depicted a remarkably high accuracy (>90%) in predicting LNI. This supports what is currently recommended by virtually all guidelines, which indicate that candidates for extended LND (eLND) should still be identified according to a combination of clinical variables only. However, although the Partin Tables might assist clinicians in identifying patients more likely to harbour LNI, the lack of the uniform adoption of an eLND template might have resulted in a substantial under-estimation of the real LNI risk [4]. Other tools specifically developed to predict LNI among men treated with eLND could better assist clinicians in identifying men who should receive an eLND [2, 5].

Similarly, when considering local staging, mp-MRI is characterised by a high specificity but a relatively low sensitivity in detecting small, microscopic foci of extracapsular extension and seminal vesicle invasion (SVI) [6]. Conversely, the updated Partin Tables depicted a predictive accuracy of >80% in predicting SVI, despite the lack of individualised data on the extent and volume of extraprostatic extension. For all these reasons, clinical risk models still represent the cornerstone for the identification of men at higher risk of adverse pathological findings. Additional data coming from sophisticated imaging modalities may further improve individualised risk predictions [6] and better assist clinicians in tailoring the most appropriate treatment approach. However, imaging and biomarkers should complement, rather than substitute, currently available clinical risk models.

In conclusion, preoperative predictive tools based on clinical parameters still play an important role in the management of patients with clinically localised prostate cancer. Any staging model including additional approaches, such as imaging and/or biomarkers, is welcomed only when it is shown to improve prostate cancer staging in terms of both accuracy and cost-effectiveness.

Read the full article

 

How to Cite

Gandaglia, G., Fossati, N., Dell’Oglio, P., Montorsi, F. and Briganti, A. (2017), Is there a role for pure clinical prediction models in prostate cancer in the contemporary era?. BJU International, 119: 652–653. doi: 10.1111/bju.13833

 

Giorgio Gandaglia,*† Nicola Fossati,*Paolo DellOglio,*Francesco Montorsi,*† and Alberto Briganti*

 

*Division of Oncology/Unit of Urology, Urological Research Institute, LIstituto di Ricovero e Cura a Carattere Scientico (IRCCS), Ospedale San Raffaele, and Vita-Salute San Raffaele University, Milan, Italy

 

References

 

 

Editorial: Touching the future – 3D printing facilitates preoperative planning, realistic simulation and enhanced precision in RALPN

Practice taking that match-winning penalty knowing which way the keeper will dive, or take that last putt knowing the lie of the green; it would be very handy wouldn’t it?

Virtual reality (VR), augmented reality (AR), computer-generated images (CGI), and stereotactic overlay, have all been documented as adjuncts in enhancing operative patient care through planning, simulation and increased precision. But what if you could actually handle the specimen and practice operating on a model to refine operative technique before the definitive procedure? With three-dimensional (3D) printing this has now become a reality.

The work of von Rundstedt et al. [1] has the potential to transform surgical planning, operative accuracy, and training, with the development of a life-like kidney and tumour model. Their paper validates a patient-specific simulation protocol to assist in surgical decision-making through operative rehearsal. They assessed the benefits of 10 patient-specific 3D renal models for preoperative planning using tissue-like silicone, and performed model tumour excision with the robot before actual robot-assisted laparoscopic partial nephrectomy (RALPN). Nephrometry scores for tumours ranged from 7 to 11, with a relatively large mean maximal tumour diameter of 40.6 mm. In validating the model the investigators compared resection times between the model and patient (6.61 vs 7.93 min, P = 0.16) and tumour volumes between computer model, excised model, and excised tumour (38.88 vs 38.50 vs 41.79 mm3, P = 0.98), showing no significant differences.

The key principles in nephron-sparing surgery are adequate oncological excision, whilst preserving maximal renal parenchyma, with minimal ischaemia time, and avoiding complications. RALPN is challenging for complex tumours, with an extended learning curve, due partly to limitations in accurate surgical planning and surgical technique. Key anatomical considerations for planning including kidney orientation, tumour position and depth, and locality of adjacent anatomical structures (vessels, collecting system), are difficult to appreciate on conventional two-dimensional axial imaging platforms; with variance in imaging and model-planned approaches clearly noted in previous studies [2].

The development of nephrometry scores have been designed to predict surgical complexity along with various simulation and modelling reconstructions to aid excisional techniques. Several other surgical specialties (orthopaedics, maxillofacial and craniofacial surgery, neurosurgery, plastic surgery [3]) have used 3D-printing technology for organ/lesion modelling or to produce accurate imaging-based prostheses. In the era of minimally invasive surgery and personalised medicine, 3D printing can be a powerful tool for uro-oncologists to better understand individual tumour characteristics and anatomical variations.

Currently there is limited published data on 3D renal tumour printing. This paper [1] represents the first model and validation of its kind. Previous studies of 3D-printed kidneys with renal masses have been reported but limited to depictions of anatomical visualisation of arteries, collecting system and the tumour itself [4, 5]. This is the first time that a model not only provides a 3D representation of the tumour anatomy but also allows high-fidelity simulated excision. Construct validity of these reproductions has been assessed and demonstrate a striking similarity in tumour volume, morphology, and resection time, the main limitations of previous studies [4].

Preoperative planning has never achieved this accuracy before. Operative rehearsal significantly altered the ultimate approach to tumour excision in several cases as noted by the authors. In addition, 3D printing represents a breakthrough in surgical training as it offers a great opportunity, especially in facilities were wet laboratories are not available.

With the small sample assessed and the subjective nature of the surgical technique modification between model and tumour excision, early generalisation may not be appropriate. Other limitations include the models inability to replicate viable orthotopic anatomy such as adjacent organs, dissection planes, perinephric fat thickness/adherence, and bleeding; while also excluding the renorrhaphy component of the procedure. Additionally, production costs and 3D printer access may be an initial deterrent to widespread use of this technique; however, it does address the lack of tactile feeling in AR or VR, avoids the specialised facilities required by animal or cadaveric models, can readily be accurately reproduced, and most importantly provide an accurate anatomical representation of the individual patient.

This is an important and interesting paper as it presents and validates a novel model with extirpative technique in a prospective manner. It provides a life-like model useful for patient education, procedural practice with realistic simulation, an accurate training platform, and is the easiest to access given current technology. Clinical trials are needed to confirm how 3D modelling is ultimately useful in: i) improving patient education, ii) enhancing surgical training, and iii) conferring superior clinical outcomes. Evolution of 3D printers and shrinking production costs will eventually contribute to the widespread usage of this technology.

Further development will provide functional models that replicate not only macroscopic structures but elements such as the collecting system, segmental vessels, and bleeding parenchyma. However, it may be that high-fidelity VR simulators or CGI that can generate patient-specific graphics or even provide an intraoperative stereotactic 3D overlay to guide tumour excision may eventually supersede 3D modelling. Urology has entered the 3D printing era. This study [1] shows that 3D printing is both a feasible and useful technique that may enhance current practice, while providing an improved training platform. The future is here today.

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How to Cite this Article

von Rundstedt, F.-C., Scovell, J. M., Agrawal, S., Zaneveld, J. and Link, R. E. (2017), Utility of patient-specific silicone renal models for planning and rehearsal of complex tumour resections prior to robot-assisted laparoscopic partial nephrectomy. BJU International, 119: 598–604. doi: 10.1111/bju.13712

Nicolo de Luyk, Benjamin Namdarian* and Benjamin Challacombe*
*Department of Urology, Guys and St Thomas Hospit als NHS Foundation Trust and Kings College, London, UK and Department of Urology, University Hospital of VeronaVerona, Italy

 

References

 

 

2 Wake N , Rude T, Kang SK et al. 3D printed renal cancer models derived from MRI data: application in pre-surgical planning. Abdom Radiol (NY) 2017; [Epub ahead of print]. doi: 10.1007/s00261-016-1022-2

 

3 LiJ, Chen M, Fan X, Zhou H. Recent advances in bioprinting techniques: approaches, applications and future prospects. J Transl Med 2016; 14: 271. doi:10.1186/s12967-016-1028-0

 

4 Silberstein JL, Maddox MM, Dorsey P, Feibus A, Thomas R, Lee BRPhysical models of renal malignancies using standard cross-sectional imaging and 3- dimensional printers: a pilot study. Urology 2014; 84: 26872

 

5 Bernhard JC, Isotani S, Matsugasumi T et al. Personalized 3D printed model of kidney and tumor anatomy: a useful tool for patient education. World J Urol 2016; 34: 33745

 

Editorial: Renal access during PCNL: increasing value of USG for a safer and successful procedure

Renal access to the pelvicalyceal system is the initial but highly important and crucial step of percutaneous nephrolithotomy (PCNL), which can significantly affect the final outcome of the procedure. Although the puncture of the kidney and subsequently dilatation of the tract has been commonly performed under fluoroscopic guidance [1]; renal access can also be established under ultrasonographic guidance (USG) with or without fluoroscopy.

To give a further insight into the role of both methods; in a prospective and randomised study published in this issue of the BJUI, Zhu et al. [2] have compared the safety and efficacy of fluoroscopic (FG), total ultrasonographic (USG), and combined ultrasonographic and fluoroscopic guidance (CG) for percutaneous renal access during mini-PCNL (mini-PCNL). In all, 450 consecutive patients with renal stones of >2 cm were randomised to undergo three different approaches during mini-PCNL. In addition to the stone-free rate (SFR) and blood loss as primary endpoints; access failure rate, operative time and complications were also evaluated. The S.T.O.N.E. [stone size (S), tract length (T), obstruction (O), number of involved calices (N), and essence or stone density (E)] scoring system was used for stone assessment [3] and the scores were further categorised into three grades (5–6, 7–8 and 9–13) for comparison.

While the overall operative complication rates, using the Clavien–Dindo grading system, were similar between the three groups; colonic injury treated with a temporary colostomy occurred in one case in the CG group. Although the SFRs were similar between the groups with S.T.O.N.E. scores of 5–6 and 9–13; the FG and CG approaches achieved significantly better SFRs than USG in patients with scores of 7–8, (P = 0.006). Multiple-tracts PCNL were used more frequently in the FG and CG group than USG group (P = 0.028). While the access failure rate was similar in the groups, the mean access time was longer in the CG group than in the FG and USG groups (P = 0.003). However, the mean total radiation exposure time was significantly greater for FG than for CG (47.5 vs 17.9 s, P < 0.001). The USG had zero radiation exposure. The operative time, hospital stay, nephrostomy drainage time, and the changes in the haemoglobin and creatinine levels were all similar in the three groups. The authors [1] concluded that mini-PCNL under total USG is as safe and effective as FG or CG in the treatment of simple kidney stones (S.T.O.N.E. scores 5–6) with no risk of radiation exposure. FG or CG is more effective for patients with S.T.O.N.E. scores of 7–8 where multiple percutaneous tracts may be necessary.

Percutaneous nephrolithotomy is now the preferred treatment method for larger stones (>2 cm) with successful outcomes. However, despite the high SFR obtained in a single session this approach can be associated with some severe complications such as bleeding, organ perforation, and sepsis. Such complications could be encountered during all steps of PCNL among which renal access seems to be the most critical one [4]. An appropriate puncture aiming a direct path from the skin through the papilla of the desired calyx of the kidney is of paramount importance to limit the above mentioned complications. Such an access to the renal collecting system can be established by either FG and/or USG. Although FG has been used commonly in the past; increasing experience in US applications has enabled endourologists to use this approach more often with some certain advantages in preventing renal puncture-related complications. When compared with FG, use of USG in establishing an access under vision allows the surgeon to identify the kidney pelvicalyceal system as well as the surrounding organs in a precise manner [5], with the benefit of minimising the risk of injury to such organs. Moreover, in addition to being free of ionising radiation; USG results in fewer punctures, has shorter operating times, and avoids contrast-related complications [1, 2]. Apart from helping to identify non-opaque residual stones at the end of the procedure; colour Doppler US can be used as a tool to localise the intrarenal arteries and avoid their puncture. However, the use of USG is an operator-dependent procedure requiring sufficient experience before routine performance and it may not be as efficient in the extremely obese patient and patients without hydronephrosis.

For the use of USG access in clinical practice, Agarwal et al. [5] reported a shorter mean time for successful puncture and significantly lower radiation exposure, yielding complete stone clearance with no substantial morbidity when compared with the FG technique. USG access was found also to increase puncture accuracy to a certain extent with a 96.5% SFR in another trial [6].

In conclusion, each of these techniques mentioned above have their own advantages and disadvantages. Despite its high success rate, radiation exposure and risk of multiple punctures are the main risks of the FG approach. USG renal access in experienced hands can produce high success rates following an appropriate puncture, lower risk of radiation exposure, and the ability to monitor all organs in the path of the puncture [7]. Depending on the surgeon’s experience, patient and stone-related factors, as well as the technical infrastructure, each approach may be used either alone or in combination for a complication-free and successful procedure. However, taking the above mentioned advantages of USG access into account, it is clear that all young urologist need to increase their experience in USG puncture to use it in appropriate cases (children, pregnant cases, dilated kidneys etc.) to lower the radiation risk and shorten the procedural duration.

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Kemal Sarica, Professor of Urology, Chief

 

Department of Urology, Health Sciences University, Dr Lut Kirdar Kartal Research and Training Hospital, Istanbul, Turkey

 

References

 

1 Michel MS, Trojan L, Rassweiler JJ. Complications in percutaneous nephrolithotomy. Eur Urol 2007; 51: 899906

 

 

3 Okhunov Z, Friedlander JI, George AK et al. S.T.O.N.E. nephrolithometry: novel surgical classication system for kidney calculi. Urology 2013; 81: 115460

 

4 Aslam MZ, Thwaini A, Duggan B et al. Urologists versus radiologists made PCNL tracts: the UK experience. Urol Res 2011; 39: 21721

 

5 Agarwal M, Agrawal MS, Jaiswal A, Kumar D, Yadav H, Lavania PSafety and efcacy of ultrasonography as an adjunct to uoroscopy for renal access in percutaneous nephrolithotomy. BJU Int 2011; 108: 13469

 

6 BasiriA, Ziaee AM, Kianian HR, Mehrabi S, Ka rami H, Moghaddam SM. Ultrasonographic versus u oroscopic access for percutaneounephrolithotomy, a randomized clinical trial. J Enodourol 2008; 22: 28 14

 

7 Osman M, Wendt-Nordahl G, Heger K, Michel MS, Alken P, Knoll TPercutaneous nephrolithotomy with ultrasonography-guided renal access: experience from over 300 cases. BJU Int 2005; 96: 8758

 

Editorial: Renal tumour biopsy: let’s talk about it

There has been a marked increase in the incidental diagnosis of small renal masses (SRMs), resulting in overtreatment of benign and indolent lesions. Renal tumour biopsy (RTB) has received increasing attention as a potential tool to help reduce this overtreatment, with single-institution studies reporting good safety, accuracy, and reliability. One of the purposes of paper by Richard et al. [1], appearing in this issue of BJUI, was to address whether these results of RTB were generalisable across multiple institutions. They evaluated 373 RTBs from 12 centres, reporting an initial diagnostic rate of 87%, with 32% of non-diagnostic RTBs undergoing repeat biopsy, for a combined diagnostic rate of 91%. They reported concordance rates between RTB and surgical pathology of >80% and a RTB complication rate of <1%. The generalisability of these impressive RTB results remains unclear because they were unable to report the numbers of RTB per centre (beyond ‘at least one’) and results were likely driven by a few high-volume centres.

The analysis is not without limitations. The negative predicative value (NPV) of RTB could not be assessed because there was no surgical specimen to confirm a benign RTB diagnosis. A meta-analysis by Patel et al. [2] raised concerns about a non-diagnostic or negative RTB. Of the 14% of patients with a non-diagnostic biopsy, 90% of those subsequently undergoing surgery were found to have cancer. Among patients having surgery, 37% with a negative biopsy who underwent surgical extirpation were found to have cancer on final pathology (NPV 63%). Another limitation of RTBs is that they tend to under grade tumours compared to surgical pathology. Even when using a simplified two-tiered grading system of low vs high grade tumours to improve concordance [3], 20% of patients with low-grade clear cell RCC (ccRCC) were upgraded to high-grade ccRCC at surgery. Concordance rates did not include non-diagnostic biopsies; nonetheless, their results support that a ‘good’ RTB can usually be trusted. Selection bias may have been a factor because patients who did not receive a RTB for a SRM were not included. It seems unlikely that reports of improved RTB outcomes would result in a change in guidelines to a ‘one size fits all’ policy recommending RTB in all patients with a SRM. RTB may not be feasible in some patients (anterior, hilar, cystic tumours) and may not always have potential to change clinical management, such as with a young healthy patient who is unwilling to accept any degree of uncertainty with a negative biopsy or an elderly patient with comorbidities who would not accept treatment regardless of RTB results. In this study [1], only ~25% of the patients who underwent surgery for a cT1a lesion had a RTB before surgery, possibly a reflection of the limitations of RTB, as well as some room for improvement.

Despite the limitations of RTB, the fact remains that many renal lesions are over treated, RTB outcomes are improving, and RTB may help guide clinical management. The authors [1] suggest that even a misclassified SRM could probably be managed conservatively over the short term. They recommend that even a benign RTB should be followed with serial imaging and that a repeat RTB should be considered for fast growing lesions. Perhaps the future of RCC diagnosis lies beyond the RTB and includes imaging innovations that can distinguish benign and malignant tumours and spare patients an unnecessary treatment, as well as an unnecessary biopsy. For example, Gorin et al. [4] showed that technetium-99m (99mTc)-sestamibi single-photon emission CT (SPECT)/CT could accurately distinguish renal oncocytomas and hybrid oncocytic/chromophobe tumours from other renal tumour histologies.

Current guidelines already acknowledge the potential role for RTB to guide clinical management in patients willing to accept the known limitations and who have an indeterminate SRM or are considering a range of treatment options such as active surveillance or ablation. We do not need a blanket guideline mandating upfront RTB for all. But we should at least talk about RTB with our patients with SRMs. We owe it to them to be aware of the potential benefits and limitations of RTB and include this in our discussion so they can be involved in the decision.

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Haider Rahbar, and Craig Rogers

 

Vattikuti Urology Institute, Henry Ford Hospital, Detroit, MI, USA

 

References

 

 

 

3 Rioux-Leclercq N, Karakiewicz PI, Trinh QD et al. Prognostic ability of simplied nuclear grading of renal cell carcinoma. Cancer 2007; 109: 86874

 

 

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