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Editorial: Combining solifenacin and mirabegron for OAB management

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Overactive bladder (OAB) is one of the most frequent LUTS in both sexes, and is associated with significant bother and impact on quality of life [1]. In many cases, no underlying cause is found and OAB is stated as being ‘idiopathic’. Until recently, the first-line management of idiopathic OAB has been based on the use of antimuscarinics, solifenacin being one of the most prescribed drugs; however, the long-term adherence to antimuscarinics has been shown to be rather low because of lack of efficacy, treatment switch or adverse events, or for mixed reasons [2].

A few years ago, β3-adrenergics were successfully introduced as an alternative to antimuscarinics for OAB management. The efficacy of β3-adrenergics has been shown and they are associated with a new safety profile that differs from that of antimuscarinics [3]. Mirabegron, the most widely used β3-adrenergic drug, has thus gained popularity in clinical practice. Given that β3-adrenergics and anticholinergics have a distinct mechanism of action, the combination of both drugs has been seen as a possible option and has been tested through a huge randomized controlled trial [4].

In the present issue of BJUI, Yamaguchi et al. [5] report the results of the MILAI study, an open-label phase IV trial assessing the effects of mirabegron as an add-on therapy in patients treated for OAB with solifenacin. They found that the addition of mirabegron to solifenacin generated only mild to moderate adverse events, and led to promising efficacy results; however, this study, which the authors call a preliminary study, raises a number of questions that remain completely unanswered.

First, even if seen as fluctuant, idiopathic OAB is considered to be a chronic disease. Long-term results must be seen as a critical issue in the field, and there is no guarantee that the short-term data presented in the MILAI study will stand the test of time in terms of efficacy and adherence.

Second, the study raises an important question about the optimum use of mirabegron in idiopathic OAB. Should it be a first-line option, a secondary option after antimuscarinics (available for treatment switch), or an add-on therapy, as it is presented in the present trial? There might be some room for each of these pathways depending on the patient history and characteristics, and the results obtained under antimuscarinics. From that point of view, the MILAI study is probably too weak to identify factors associated with failure of the combination therapy. Further studies should better detail patient inclusion criteria (because ‘failure’ of antimuscarinics is a heterogeneous concept), as well as characteristics of non-responders. In the present study, these two points are not detailed, and the study provides only a global statistically significant improvement, paving the way for additional research. A better understanding of the mechanism of action of the treatment combination would be of great value to move forward and enable better patient selection.

Finally, one of the upcoming challenges will be to integrate mirabegron as an add-on therapy in the world of male LUTS, including benign prostatic obstruction, where β3-adrenergics probably have an important role to play. As underlined by the authors, several studies are on the way, and their results (in a male population) are urgently awaited.

After having been successfully introduced in most countries in the western world, the new life of mirabegron has begun (including post-marketing studies, extensions of market authorizations, potentially new indications, combination therapy). The future will tell us whether this success story will continue.

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Jean-Nicolas Cornu 
Department of Urology, Tenon Hospital, Hopitaux Universitaires Paris-EST, Assistance publique Hopitaux de Paris, Universite Pierre et Marie Curie Paris 6, Paris, France

 

References
1 Agarwal A, Eryuzlu LN, Cartwright R et al. What is the most bothersome lower urinary tract symptom? Individual- and population- level perspectives for both men and women. Eur Urol 2014; 65: 1211–7

2 Veenboer PW, Bosch JL. Long-term adherence to antimuscarinic therapy in everyday practice: a systematic review. J Urol 2014; 191: 1003–8

3 Maman K, Aballea S, Nazir J et al. Comparative efficacy and safety of medical treat ment s for the management of o veractive bl adder: a syste matic literature review and mixed treatment comparison. Eur Urol 2014; 65: 755–65

 

4 Abrams P, Kelleher C, Staskin D et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol 2014; 67: 577–88

 

5 Yamaguchi O, Kakizaki H, Homma Y et al. Safety and efficacy of mirabegron as add-on therapy in patients with overactive bladder treated with solifenacin: a post-marketing, open-label study in Japan (MILAI study). BJU Int 2015; 116: 612–22

 

 

Editorial: Robotic Partial Nephrectomy: The Treatment of Choice for Minimally Invasive Nephron Sparing Surgery

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Early in the adoption of robotic partial nephrectomy (RPN) as an alternative to laparoscopic PN (LPN) for the treatment of small renal masses, several of the current authors presented a similar comparison of LPN and RPN. They found RPN to result in shorter hospital stay, less blood loss, and shorter warm ischaemia time (WIT) compared with LPN [1]. They discovered that RPN outcomes were not dependent on the complexity of the tumour, which clearly impacted LPN results. They concluded that RPN is a safe and viable alternative to LPN and offered benefits even for experienced laparoscopic surgeons.

The current report in this edition of BJUI furthers the comparison of RPN and LPN and expands the assessment to include five high-volume centres of excellence in robotic surgery [2]. This retrospective, multi-institutional review of 1 185 RPN and 646 LPN represents the largest comparison to date of these two approaches for minimally invasive PN. Despite higher patient comorbidities and R.E.N.A.L. nephrometry scores in the RPN patients compared with the LPN group, there were fewer overall complications (16.2% vs 25.9%), a lower positive surgical margin rate (3.2% vs 9.7%) and a lower WIT (18 vs 26 min). They also found a much higher percentage of RPN patients (70% vs 33%) meeting the Trifecta criteria, defined as negative surgical margins, no perioperative complications, and a WIT of ≤25 min. Finally, the authors introduce a more stringent composite measure of ‘optimal outcomes’, which is the Trifecta with the addition of 90% estimated GFR preservation and no chronic kidney disease upgrading. They report 38.5% of RPN patients meeting optimal outcomes compared with 24.1% for LPN.

This study clearly demonstrates the superiority of RPN over LPN and is supported by other single-surgeon reports [3]. These results also exceed those reported for open PN with the added benefit of reduced hospital stay [4]. However, it is important to recognise that these results represent a mature experience with RPN by the leaders in the field of robotic renal surgery. Many of these authors pioneered the techniques currently used for RPN, and therefore these results may not apply to centres without the same experience or case volumes. One limitation of this report is the non-concurrent experience of LPN and RPN. The results of RPN came after an initial experience with LPN and therefore the outcomes of RPN may have benefitted from the lessons learned with LPN prior to RPN.

Reporting surgical outcomes as composite results, such as the Trifecta, allows for comparison between reports and sets an outcomes bar for future studies. Most composite measures include assessment of surgical margin status and complications, but there is no current agreement as to the optimal measure of renal functional outcomes. The current Trifecta used a WIT of ≤25 min as a measure of renal function impact, while the margin, ischaemia, and complications (MIC) score uses a WIT of <20 min [5], and others have used 90% renal parenchyma preservation as part of the Trifecta [6]. The impact of WIT on renal function has been questioned given the recently recognised importance of preserved renal parenchyma as an important predictor of renal function after PN [7]. Until there is consensus as to the best measure of renal function after nephron-sparing surgery, composite outcomes such as the Trifecta and the optimal outcomes as described by the authors will have limited utility.

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James Porter
Robotic Surgery, Swedish Medical Center, Seattle , WA, USA
References

 

1 Benway BM, Bhayani SB, Rogers CG et al. Robot assisted partial nephrectomy versus laparoscopic partial nephrectomy for renal tumors: a multi-institutional analysis of perioperative outcomes. J Urol 2009; 182:866–72

 

2 Zargar H, Allaf M, Bhayani S et al. Trifecta and optimal perioperative outcomes of robotic and laparoscopic partial nephrectomy in surgical treatment of small renal masses: a multi-institutional study. BJU Int 2015; 407–14

 

3 Mullins JK, Feng T, Pierorazio PM, Patel HD, Hyams ES, Allaf ME. Comparative analysis of minimally invasive partial nephrectomy techniques in the treatment of localized renal tumors. Urology 2012; 80: 316–21

 

4 Gill IS, Kavoussi LR, Lane BR et al. Comparison of 1800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol 2007; 178: 41–6

 

5 Buffi N, Lista G, Larcher A et al. Margin, ischemia, and complications (MIC) score in partial nephrectomy: a new system for evaluating achievement of optimal outcomes in nephron-sparing surgery. Eur Urol 2012; 62: 617–8

 

6 Hung AJ, Cai J, Simmons MN, Gill IS. “Trifecta” in partial nephrectomy. J Urol 2013; 189: 36–42

 

7 Mir MC, Campbell RA, Sharma N et al. Parenchymal volume preservation and ischemia during partial nephrectomy: functional and volumetric analysis. Urology 2013; 82: 263–8

 

Functional urology is coming to you!

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Dirk resizedThis month’s edition features three interesting papers in the field of functional urology. Overactive bladder (OAB) syndrome has a prevalence of 14%, prostatitis symptoms have a prevalence in the male population of 8.2% and a substantial number of all men undergoing radical prostatectomy will remain incontinent. These are clinical entities that every urologist encounters in his daily practice.

The treatment of refractory OAB symptoms with anticholinergics, can be optimized by adding mirabegron in a flexible dose scheme. This has been nicely shown in a Japanese population by Yamaguchi et al. [1]. Despite the fact that Japanese health authorities recommend starting with a lower dose of 2.5 mg of solifenacin or 25 mg of mirabegron, these data can be extrapolated to other populations as well, where 5 mg of solifenacin and 50 mg of mirabegron are used as standard doses.

Chronic bacterial prostatitis and chronic pelvic pain syndrome are difficult to deal with. As there is a lack of well-designed prospective randomized controlled studies in this field, Rees et al. [2] used the Delphi consensus methodology to draw up experience- and science-based consensus guidelines. Their Delphi panel included 58 participants consisting of GPs, urologists, pain specialists, nurse specialists, physiotherapists, cognitive behavioural specialists and sexual health specialists. The guidelines give a well-structured overview of the diagnostic and therapeutic possibilities for chronic bacterial prostatitis and chronic pelvic pain syndrome.

Post-radical prostatectomy incontinence varies widely from 3 to 87%. Artificial sphincters are still the main treatment for this complication. While the results in non-irradiated patients might be good in the long term, it remains unclear how external beam radiotherapy would affect the outcome of artificial sphincters in post-radical prostatectomy incontinence. Bates et al. [3] performed a meta-analysis on the complications occurring after the implantation of an artificial sphincter after radical prostatectomy and radiotherapy. The combination of radical prostatectomy and external beam radiotherapy increases the risk of infection and erosion and urethral atrophy and results in a greater risk of surgical revision compared with radical prostatectomy alone. Also persistent urinary incontinence is more common in this population.

These three papers highlight important and relevant problems in urology. It is clear from these papers that we need more insight and more research into the underlying mechanisms of these highly prevalent entities. With an ageing population that wants to remain active as long as possible, we need to invest more time, people and money in this field to improve the quality of life of these patients. Basic science and clinical science need to work together to improve our knowledge and understanding.

Functional urology is coming to you! You will not escape from this growing population.

 

References

 

1 Yamaguchi O, Kakizaki H, Homma Y et al. Safety and efficacy of mirabegron as ‘add-on’ therapy in patients with overactive bladder treated with solifenacin: a post-marketing, open-label study in Japan (MILAI study). BJU Int 2015; 116: 612–22

 

2 Rees J, Abrahams M, Doble A, Cooper A. Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline. BJU Int 2015; 116: 509–25

 

3 Bates AS, Martin RM, Terry TR. Complications following artificial urinary sphincter placement after radical prostatectomy and radiotherapy: a meta-analysis. BJU Int 2015; 116: 623–33

 

Dirk De Ridder
Department of Urology, University Hospitals KU Leuven, Leuven, Belgium

 

 

Editorial: Do ‘whale noises’ help in the diagnosis of Fowler’s syndrome?

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In 1985, Clare Fowler described the presence of abnormal electromyography (EMG) signals in the urethral sphincter of five women with unexplained urinary retention [1]. The presence of complex repetitive discharges (CRD) and decelerating bursts (DB) in women with urinary retention became an important diagnostic finding. Initially, it was described as an EMG finding resembling pseudomyotonia (delayed relaxation of striated muscle when deep tendon reflexes are elicited). Later, an association with polycystic ovary syndrome was hypothesized [2]. This hypothesis could not be proven, however, and the diagnostic criteria that were used at that time for diagnosing polycystic ovaries did not stand the test of time.

The main achievement of urethral sphincter EMG in women with urinary retention was the fact that, from that point onwards, women who were previously described and as being hysterical could now finally be assured that there was a measurable abnormality within their urethral sphincter. This was a major breakthrough in the management of women with urinary retention. Previously, most of these women ended up with permanent catheters or intermittent catheterization, while being stigmatized as psychiatric patients.

The presence of this EMG abnormality also seemed to correlate with the long-term outcome of sacral nerve stimulation [3]. Sacral nerve stimulation is now the standard of care for women with Fowler’s syndrome.

Many authors have questioned the value of these EMG findings. Ramm et al. [4] found the presence of CRD in 30% of healthy women and Tawadros et al. [5] also found this in 53% of healthy female volunteers. These authors showed that CRD and DB are mostly present during the luteal phase of the menstrual cycle. These results suggest at least some hormonal influence on the EMG findings. Fitzgerald et al. [6] showed that CRD correlated weakly with a history of strained voiding and urethral dilation, suggesting a higher prevalence in women with signs of obstructive voiding. Currently, however, the presence of CRD and DB is considered as non-specific.

While sphincter overactivity is generally accepted as the underlying aetiology in women with urinary retention, proving this overactivity remains a challenge. Urethral pressure profiles and urethral volume measurements by ultrasonography have a high interobserver variability and must be used with caution. Most publications originate from one centre and have not been reproduced by others [7]. MRI measurements of the urethral sphincter could possibly be helpful in the future.

While in healthy women CRD can be present, more research will be needed to establish the real value of sphincter EMG in women with pathological urinary retention. The design of good clinical trials will be difficult because of the limited number of patients with this condition. Currently, the diagnosis of Fowler syndrome remains a clinical one, based on a multimodal assessment of the patient.

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Dirk De Ridder
Department of Urology, University Hospitals KU Leuven, Leuven, Belgium

 

References

 

1 Fowler CJ, Kirby RS, Harrison MJ. Decelerating burst and complex repetitive discharges in the striated muscle of the urethral sphincter, associated with urinary retention in women. J Neurol Neurosurg Psychiatry 1985; 48: 1004–9

 

2 Fowler CJ, Christmas TJ, Chapple CR, Parkhouse HF, Kirby RS, Jacobs HS. Abnormal electromyographic activity of the urethral sphincter, voiding dysfunction, and polycystic ovaries: a new syndrome? BMJ 1988; 297: 1436–8

 

3 De Ridder D, Ost D, Bruyninckx F. The presence of Fowler’s syndrome predicts successful long-term outcome of sacral nerve stimulation in women with urinary retention. Eur Urol 2007; 51: 224–9

 

4 Ramm O, Mueller ER, Brubaker L, Lowenstein L, Kenton K. Complex repetitive discharges–a feature of the urethral continence mechanism or a pathological finding? J Urol 2012; 187: 2140–3

 

5 Tawadros C, Burnett K, Derbyshire LF, Tawadros T, Clarke NW, Betts CD. External urethral sphincter electromyography in asymptomatic women and the influence of the menstrual cycle. BJU Int 2015; 423–31

 

6 FitzGerald MP, Blazek B, Brubaker L. Complex repetitive discharges during urethral sphincter EMG: clinical correlates. Neurourol Urodyn 2000; 19: 577–83

 

7 Wiseman OJ, Swinn MJ, Brady CM, Fowler CJ. Maximum urethral closure pressure and sphincter volume in women with urinary retention. J Urol 2002; 167: 1348–51; discussion 1351–2.

 

Editorial: Hot topic of cancer survivorship and the ‘seven deadly sins’

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Cancer survivorship has become a hot topic as overall mortality for most cancer patients continues to decrease, the worldwide population continues to age and as patients become more information savvy [1-3]. Gavin et al. [4] provide a data-rich population-based patient survey of seven of the most common physical symptoms after prostate cancer treatment. While we, as urologists and prostate cancer providers, may not be able to recount the seven deadly sins or the seven dwarfs, we do know these seven symptoms: impotence; incontinence; bowel problems; fatigue; hot flushes; loss of libido; and breast symptoms. Urological surgeons and radiation oncologists talk to patients every day about the ‘big three’ of these: impotence, incontinence and bowel problems. Gavin et al. provide the striking statistic that ~1.6% of the male population over the age of 45 years is a prostate cancer survivor currently living with one of the seven.

The paper describes mailed survey results from a population-based cohort of 3 348 prostate cancer survivors 2–15 years after diagnosis with a response rate of 54%. The average age of respondents was 64.9 years, 64% had localized disease at presentation, 65% had Gleason 5–7 disease, and 48, 32 and 20% were surveyed 2–4.9, 5–9.9 and >10 years after diagnosis, respectively. The paper is chock full of descriptive statistics about rates of past and ongoing side effects of the various treatments and essentially has ‘something for everyone’. For example, at baseline before treatment, 51.2% of respondents reported urinary frequency, 18.8% reported impotence and 14.7% reported loss of libido. These data may be useful for estimating population-based general men’s health disease. After treatment, radical prostatectomy (RP) had the highest rates of impotence (76% current) and incontinence (current 28%; ever 70%); however, the authors examined radiation plus hormonal therapy and found impotence rates of 64% and rates of hot flushes, breast changes and bowel problems in the 20–27% range. Table 3 and Figs 3 and 4 in the paper are particularly useful to further examine the seven side effects with treatment.

On the one hand, these data could be useful in educating patients about treatment options for prostate cancer and what they might expect should they choose one treatment over another. Ideally, this education would occur in the multidisciplinary clinic setting [5]. On the other hand, these data could also be used in the wrong way. For example, an aggressive surgeon could selectively present the ‘deadly downsides’ of radiation while downplaying the ‘surgical sins’, whereas a radiation oncologist could do just the opposite to try to influence his or her patients. This highlights the limitations of the present study. While the authors are to be congratulated for a wonderful population-based survey, no control group was surveyed and, more importantly, the authors do not address satisfaction and regret. In other words, the seven side effects must be placed into the patient’s overall satisfaction regarding cancer control and the patient’s ‘trade-offs individualized internal assessment’. For example, our group examined satisfaction and regret after open and robot-assisted RP, finding an ~80–85% satisfaction rate despite levels of impotence and incontinence slightly lower but similar to those in the present population-based survey [6]. While patients who underwent open RP enjoyed more satisfaction and less regret, we attributed much of this to the ‘used car salesman’ approach to ‘selling’ robot-assisted RP in the last decade [7]. In other words, we hypothesized that patients undergoing robot-assisted RP were misled into believing the robot would lessen or eliminate the surgical sins while those undergoing open RP were counselled more realistically. Also, we found that in multivariable analysis, African-American patients exhibited more regret [6]. These data point to the fact that the present study from Ireland may not be applicable to other populations, particularly those with a mixed or different ethnic make-up. Another limitation to population-based data is the impact of centres of excellence and highly experienced treatment providers. The impact of high-volume surgeons/providers on treatment outcomes is now being recognized as a critical variable that is rarely accounted for in case series, multicentre studies or population data as seen here.

Overall, Gavin et al. are to be commended for a very rich source of side effect data for a large population-based cohort of prostate cancer survivors. The ‘seven deadly sins’ of possible side effects/complications of prostate cancer treatment should be shared openly and honestly with our patients. Furthermore, physicians and healthcare systems must be encouraged to collect provider and system-specific data to better fine-tune our pre-treatment counselling that will ultimately improve the satisfaction of our cancer survivors.

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Judd W. Moul
Duke Cancer Institute, Durham, NC, USA

 

References

1 Resnick MJ, Lacchetti C, Bergman J et al. Prostate cancer survivorship care guideline: American society of clinical oncology clinical practice guideline endorsement. J Clin Oncol 2015; 33: 1078–85

2 Skolarus TA, Wolf AM, Erb NL et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin 2014; 64: 225–49; Erratum in: CA Cancer J Clin. 2014; 64: 445

3 Gupta S, Peterson AC. Stress urinary incontinence in the prostate cancer survivor. Curr Opin Urol 2014; 24: 395–400

4 Gavin A, Drummond F, Donnelly C, O’Leary E, Sharp L, Kinnear H. Patient reported ‘ever had’ and ‘current’ long-term physical symptoms following prostate cancer treatments. BJU Int 2015.

5 Stewart SB, Ba~nez LL, Robertson CN et al. Utilization trends at a multidisciplinary prostate cancer clinic: initial 5-year experience from the Duke Prostate Center. J Urol 2012; 187: 103–8

6 Schroeck FR, Krupski TL, Sun L et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol 2008; 54: 785–93

7 Schroeck FR, Krupski TL, Stewart SB et al. Pretreatment expectations of patients undergoing robotic assisted laparoscopic or open retropubic radical prostatectomy. J Urol 2012; 187: 894–8

 

Editorial: Temporary Erectile Dysfunction Following Prostate Biopsy

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TRUS-guided prostate needle biopsy (PB) is considered to be the ‘gold standard’ for the diagnosis of prostate cancer. While serious side-effects (e.g. infection, sepsis and urinary retention) can occur after PB, they are relatively rare. Minor side-effects, including haematuria, haematospermia, rectal discomfort and bleeding, are more common but are usually self-limiting. As such, men undergoing biopsy are usually counselled about these risks, which generally occur at an acceptably low frequency and are outweighed by the potential benefits of PB.

Penile erection is a complex physiological process that occurs through a coordinated cascade of neurological, vascular, humoral and psychological events. Therefore, there are a multitude of factors that could ultimately influence or disrupt normal erectile function after PB, including type of anaesthetic, age, psychological stress and damage to the neurovascular bundles. Erectile dysfunction (ED) and worsening LUTS have been reported to occur after PB, but the true incidence and possible pathophysiology remain subject to debate. For example, in their manuscript entitled, ‘A prospective study of erectile function after transrectal ultrasound and prostate biopsy’, Murray et al. [1] conducted a prospective study assessing erectile function, measured by the International Index of Erectile Function (IIEF-5), and LUTS, measured by the IPSS, after PB. The results suggest that there is a significant decrease in erectile function that persists up to 3 months after PB. By contrast, worsening LUTS were not documented at this time after PB.

The present prospectively conducted trial [1] supports the findings of some other retrospective studies [2], but contradicts others [3–5]. For example, Helfand et al. [6] previously documented that a diagnosis of prostate cancer can influence a man’s erectile function after PB. Similarly, Murray et al. [1] found that patients without a diagnosis of prostate cancer reported lower IIEF scores up to 3 weeks, whereas those diagnosed with the disease had significantly lower IIEF scores up to 3 months after PB. Taken together, these results support other studies [2,6] showing that the psychological stress associated with a cancer diagnosis might contribute to ED.

Other recent studies have supported the notion that PB does not influence the frequency of ED [3–5]. These data have been mainly obtained from studies of men undergoing repeated PB as part of an active surveillance protocol. Some of these discrepancies might be related to the timing of evaluation after PB (e.g. 3 vs 12 months). Nonetheless, other studies found that age may be a better predictor of changes in erectile function. For example, data obtained from Braun et al. [3] support that men who undergo multiple biopsies (a median of five PB) fail to report substantially decreased erectile function over time. Similarly, Hilton et al. [4] found that erectile function scores were strongly associated with age and sexual activity, and not number of PBs. In support of this age relationship, the present study found that men aged <60 years had lower IIEF scores only at 1 week, compared with those patients aged >60 years who continued to report sexual side-effects up to 3 months after PB [1].

When the results of Murray et al. [1] are considered in light of previous studies on this topic, it appears that patients should be counselled on the possibility of relatively short-term (‘acute’) changes in erectile function. However, it should also be emphasised that long-term ED might not be related to the PB procedure itself, but rather to other factors, including advanced age, psychological stress and/or prostate cancer diagnosis.

 

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Brian Helfand

North Shore University Health System, Division of Urology, John and Carol Walter Center for Urological Health, Evanston, IL, USA.

University of Chicago, Chicago, IL, USA.

 

References

1 Murray KS, Bailey J, Zuk K, Lopez-Corona E, Thrasher JB. A prospective study of erectile function after transrectal ultrasound and prostate biopsy. BJU Int 2015; 116: 190–5

2 Zisman A, Leibovici D, Kleinmann J, Cooper A, Siegel Y, Lindner A. The impact of prostate biopsy on patient well-being: a prospective study of voiding impairment. J Urol 2001; 166: 2242–6

3 Braun K, Ahallal Y, Sjoberg DD et al. Effect of repeated prostate biopsies on erectile function in men on active surveillance for prostate cancer. J Urol 2014; 191: 744–9

4 Hilton JF, Blaschko SD, Whitson JM, Cowan JE, Carroll PR. The impact of serial prostate biopsies on sexual function in men on active surveillance for prostate cancer. J Urol 2012; 188: 1252–8

5 Chrisofos M, Papatsoris AG, Dellis A, Varkarakis IM, Skolarikos A, Deliveliotis C. Can prostate biopsies affect erectile function? Andrologia 2006; 38: 79–83

6 Helfand BT, Glaser AP, Rimar K et al. Prostate cancer diagnosis is associated with an increased risk of erectile dysfunction after prostate biopsy. BJU Int 2013; 111: 38–43

Editorial: Exercise, diet and weight loss before therapy for LUTS/BPH?

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In recent decades we have had access to an increasing body of evidence evoking a strong relationship between metabolic syndrome and the development of LUTS/BPH. This relationship suggests that metabolic syndrome might be responsible not only for putting patients at higher risk of developing LUTS/BPH but also for influencing the response and outcome of therapy. In a study in the present issue of BJUI [1] it has been observed that patients with a greater waist circumference, a sign of metabolic syndrome, are at a higher risk of experiencing persistent LUTS after either TURP or open prostatectomy for BPH. Likewise, in a recent systematic review and meta-analysis, a strong relationship between metabolic syndrome and prostatic enlargement was observed, underlining the exacerbating role of this syndrome in inducing the development of benign prostate enlargement as obese, dyslipidaemic and aged men have a higher risk of metabolic syndrome being a determinant factor of their prostate enlargement [2].

Metabolic syndrome is a constellation of clinical findings characterizing patients affected by a combination of abdominal obesity, elevated serum triglyceride levels, lowered HDL cholesterol levels, increased blood pressure or a high level of plasma glucose. It has also been considered an important risk factor for the eventual development of a number of diseases including type 2 diabetes, coronary vascular disease, fatty liver disease, chronic kidney disease and hyperuricaemia [3]. Furthermore metabolic syndrome has been recently associated with an increased risk of clinical progression of LUTS/BPH in men with moderate to severe LUTS, reinforcing this syndrome as a factor for progression in addition to IPSS score, prostate volume, PSA, maximum urinary flow rate and post-void residual urine volume [4]. Several studies have recently shown that patients with LUTS/BPH and metabolic syndrome have a higher prostate volume than those without, and express a worse response to pharmacological therapy, suggesting the need to consider this at the time of selecting patients with LUTS/BPH for drug therapy [5, 6]. Check these leptitox reviews for harmless and natural weight loss treatment.

Several factors in the development of metabolic syndrome have been elucidated, including hyperinsulinaemia and autonomic hyperactivity, increased adiposity, ischaemia and hypoxia, chronic proinflamatory state and abnormal androgen levels. These factors are probably inter-related. A lack of exercise, together with obesity, may lead to insulin resistance, exerting a detrimental effect on lipid ratios decreasing blood levels of HDL cholesterol and increasing blood levels of triglycerides and LDL cholesterol. These undesirable levels of cholesterol may lead to deposits of atheromatous plaques in artery walls, increasing the risk of cardiovascular disease. In addition, hyperinsulinaemia may lead to sodium retention, causing hypertension.

The implications for clinical practice are that, if metabolic syndrome is related to the development of BPH/LUTS, lifestyle interventions including weight loss (you can check resurge reviews and find how this supplement heal you losing weight), a healthy diet, and physical activity would have a positive effect in both symptom relief and disease progression. As a consequence we should develop management strategies to address both the symptoms and the underlying processes, not only because men with LUTS/BPH and metabolic syndrome respond worse than those without metabolic syndrome, but also because lifestyle change, a healthy diet and exercise might be enough to achieve symptom improvement and decrease the risk of cardiovascular disease, prevent most obesity related conditions just by reading these meticore reviews.

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David Castro-Diaz
Department of Urology, University Hospital of the Canary Islands, University of La Laguna, Tenerife, Spain

Clever surgeons and challenging study endpoints

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CaptureIntraoperative in vivo tracking of a periprostatic nerve with multiphoton microscopy in rat model.

In the last 6 months, the BJUI editorial team has evaluated an average of 59 urological oncology papers per month with an average acceptance rate of 16%. We receive additional papers for our ‘Translational Science’ section. Studies with high-quality methods are given the highest priority. Other papers compete well if they are highly applicable to clinical practice (i.e. comparative, multicentre, multi-surgeon design) and/or show us new ideas in surgical technique, re-designed study endpoints, or explore new sources of data. For translational science, the best candidates are studies that look at new diagnostic tests in humans and beyond simple immunostaining techniques. We want to evaluate biomarkers likely to be validated and translated into a clinical test. Clinical impact will be even higher if a biomarker is linked to a therapy outcome rather than just a risk estimate. We want our papers to guide us to better outcomes for our patients, hopefully control healthcare costs, and, yes, be well-cited in the literature.

Our review process is tough but fair, and we congratulate and highlight three authorship groups for acceptance into this month’s issue of BJUI. The theme of ‘clever surgeons and challenging study endpoints’ is well illustrated by all three groups. Zargar et al. [1] report on an exclusive database of high-volume minimally invasive surgeons who have tackled the partial nephrectomy option for small renal masses. The comparison is simple in concept and retrospective in design, but what they have done is to significantly increase the outcome measures into a ‘trifecta’ concept in perioperative outcomes (previously reported) with an even more stringent ‘optimal outcome’ endpoint that includes renal function preservation. With a database of 1185 robotic and 646 laparoscopic cases, the robotic procedures showed superior trifecta results (70% vs 33%), complication rates (14.8% vs 20.9%), positive surgical margin rates (3.2% vs 9.7%), and warm ischaemia time (18 vs 26 min). The optimal outcome endpoint included a minimum 90% estimated GFR (eGFR) preservation and no chronic kidney disease upstaging. Only the robotic cohort had sufficient data available and the rate was 38.5%. The latter figure is an interesting challenge, as defining such a high threshold for success challenges surgical technique and allows more room to identify incremental advancement. This may be the largest study of its kind, but non-randomised and with limitations discussed in peer review such as the learning curve influence, use of eGFR as an endpoint with two kidneys, and incomplete data. The definitions used are of interest and the field could use some uniformity moving forward in measuring perioperative and long-term benchmarks of quality.

Durand et al. [2] give us a glimpse into the future of surgery, a science fiction world of prostate surgery where nerves and prostatic glands can be colour coded and seen at a microscopic level in real time. The pictures stand for themselves, especially Fig. 1. If such imaging can be integrated into technique decisions, and perhaps future instrument designs, then perhaps we will have a whole new wave of studies possible on linking surgical technique to improved functional and oncological outcomes after radical prostatectomy. The paper has a nice depth in detail, methods, results, as well as narratives in solving technical problems with novel technology.

This issue’s ‘Article of the Month’ by Gavin et al. [3] is a different look at the question of morbidity after localised prostate cancer treatments, specific to long-term care at >2 years from treatment. The database is from a cancer registry and they have an impressive 54% response rate from a population that is 2–18 years from diagnosis. Rather than Likert-like scales of symptom severity, they simply look at ‘current’ vs ‘ever had’ symptoms and look at the total burden including multiple/overlapping symptoms. Although this may not be as robust and validated as the Expanded Prostate Cancer Index Composite (EPIC) instrument, the simple phrasing of ‘current’ vs ‘ever had’ is probably capturing a very high proportion of symptoms rather than dismissing them if minor or in the past. Again, we see more erectile dysfunction after radical prostatectomy and radiation with hormonal therapy, and more bowel symptoms after radiation therapy. Hormone therapy patients have hot flashes and fatigue, and watchful-waiting patients have some advantages but are certainly not free of symptoms. The burden of symptoms is interesting, nine of 10 reported at least one of seven key symptoms at some point and three of four are current. Therefore, as the authors indicate, ≈75% of prostate cancer survivors will have ongoing symptoms needing follow-up care. This is a significant database resource adding to our understanding of long-term outcomes of patients with prostate cancer and supporting the significance of the Durand et al. [2] study that may show the way forward towards reducing such burdens of disease treatment.

 

References

1 Zargar H, Al laf ME, Bhayani S et al. Trifecta and optimal perioperative outcomes of robotic and laparoscopic partial nephrectomy in surgical treatment of small renal masses: a multi-institutional study. BJU Int 2015; 407–14

 

2 Durand M, Jain M, Aggarwal A et al. Real-time in vivo periprostatic nerve tracking using multiphoton microscopy in a rat survival surgery model: a promising pre-clinical study for enhanced nerve-sparing surgery. BJU Int 2015; 478–86

 

3 Gavin AT, Drummond FJ, Donnelly C, O’Leary E, Sharp L, Kinnear HR. Patient-reported ‘ever had’ and ‘current’ long-term physical symptoms after prostate cancer treatments. BJU Int 2015; 397–406

John W. Davis, MD
Associate Editor, BJUI

Editorial: Robotic Networks – delivering empowerment through integration

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Intuitive’s latest version of Connect™ for the Da Vinci Si model allows surgeons to communicate remotely via a laptop or personal computer, direct to the surgeon’s console. It has one-way video from the console to the remote mentor and bi-directional audio and telestration (drawing), replicating the successful strategy employed in many industries to develop networks, to share expertise and knowledge. The study published by Shin et al. [1] in this issue of BJUI is a technical proof of concept study and is an important first step to realising the potential of robotic networks. The study describes the application of Connect on a local area network (LAN), which is a network that interconnects computers in a limited geographical area such as a hospital, whereas a wide access network (WAN) is a computer network spanning regions, countries or even the world. The next logical advance for Connect is to study connections between different institutions, states and even internationally between countries. Connections between two UK NHS trusts have been successfully trialled, with plans for formal connections between hospitals in Sweden and the UK underway.

Minimally invasive surgery using video technologies has greatly improved opportunities for surgical learning. Telementoring has existed in various forms for >20 years and has been shown to have a positive impact on outcomes [2]. In a study by Påhlsson et al. [3], telementoring delivered by a high-volume surgeon at a tertiary hospital to a low-volume rural hospital, increased their cannulation rate in endoscopic retrograde cholangiopancreatography from 85% (one of the lowest in the country) to 99% (highest success rate).

While robotic surgery continues to evolve quickly, it remains an expensive service with required investment in surgeons’ learning curves in both established and new techniques. Maximum value is realised once the team is experienced, efficient and outcomes are optimised. Even between tertiary centres of excellence there are different skill sets. Successful collaborative approaches to training have potential to steepen learning curves. With Connect robotic trainers will have the additional option to disseminate their knowledge from a distance, without the need for mentor or mentee to travel.

Current healthcare WANs between hospitals can enable secure, quality assured connections over national and international networks. Connect will have a role in LANs [1]; however, studying telementoring across larger networks will probably define its beneficial effects on the learning curve. Connections between centres with the largest difference in skill sets are likely to show the greatest impacts.

Robotic networks are likely to exist in various forms and telementoring could be complemented by supplementary services delivered over both local and wide access networks. Future potential services over a LAN include real-time multi-disciplinary teams with direct communication from the console to the radiologists and histopathologists.

Simulators have been used in industries outside healthcare, such as the aviation industry, to measure both proficiency and technical skill learning. Although robotic surgical simulation has not yet reached a stage where it replicates all aspects of robotic surgical procedures, it currently has potential to accelerate trainees along their learning curve outside the operating room and thus contribute to patient safety. Simulators greatest future value may be aligned with the data and feedback that robotic networks will provide, replicating the roles of airport control centres and flight simulators. With better understanding of surgical learning curves and the ability to score and differentiate between performance levels [4], data collected via networks may also have a future role in regulation of surgery (Fig. 1).

image

Figure 1. Potential effect of robotic networks on identifying suboptimal technique and improving patient outcomes. (*Connect and Simulation diagrams by Intuitive Surgical™).

International robotic networks will help achieve balance between the continual cycle of optimisation and standardisation of robotic surgical techniques. Standardised live surgery broadcast from home institutions [5] could support and promote both telementoring and the benefits of standardised surgical techniques [5, 6]. Standardisation is critical to developing cohesive networks with better understanding between mentors and mentees. It also aids identification of the ‘hazard’ steps in complex multistep procedures, enabling strategies to avoid the associated complications [6].

Sharing of expertise requires shared goals. In highly competitive healthcare systems where hospitals compete in attracting patients, there is inherent resistance to sharing. Connect enables interaction between mentor and mentee and once hard endpoints are identified and the beneficial effects of sharing are studied, new thinking in robotic surgery is likely. If benefits to surgical outcomes and improved safety using Connect are confirmed, both legal and reimbursement issues will probably be resolved.

In conclusion, change is driven on varying scales from local discussion, to national and international opinion and debate. While Connect will undoubtedly enhance communication between surgeons, it is the development of WANs, connecting the centres with the biggest differences in skill sets, which may deliver the greatest improvements. Collaboration via robotic networks has the potential to not only enable but to drive advancement in multiple areas of robotic surgery through the sharing of knowledge, innovations and expertise, resulting in continuous incremental improvement.

Read the full article
Justin Collins, Consultant Urologists, Olof Akre, Consultant Urologists, Benjamin Challacombe*, Consultant Urologists, Omer Karim†, Consultant Urologists and Peter Wiklund, Professor
Department of Urology, Karolinska University Hospital, Stockholm, Sweden, *Department of Surgery and Cancer, Kings College, Guy’s Hospital, London, and †Department of Urology, Wexham Park Hospital, Slough, UK

 

References

 

1 Shin DH, Dalag L, Azhar Raed A et al. A novel interface for the telementoring of robotic surgery. BJU Int 2014; [Epub ahead of print]. DOI: 10.1111/bju.12985.

 

2 Challacombe B, Kandaswamy R, Dasgupta P, Mamode N. Telementoring facilitates independent hand-assisted laparoscopic living donor nephrectomy. Transplant Proc 2005;37:613–6. 

 

3Pahlsson HI, Groth K, Permert J et al. Telemedicine: an important aid to perform high-quality endoscopic retrograde cholangiopancreatography in low-volume centers. Endoscopy 2013;45:357–61.

 

4 Bonrath EM, Zevin B, Dedy NJ, Grantcharov TP. Error rating tool to identify and analyse technical errors and events in laparoscopic surgery. Br J Surg 2013;100:1080–8.

 

5 Collins JW, Akre O, Wiklund PN. Re: Walter Artibani, Vincenzo Ficarra, Ben J. Challacombe et al. EAU Policy on Live Surgery Events. Eur Urol 2014; 66: 87–97. Eur Urol 2014; 66: e121–2.

 

6 Collins JW, Tyritzis S, Nyberg T et al. Robot-assisted radical cystectomy – description of an evolved approach to radical cystectomy. Eur Urol 2013;64:654–63.

 

Editorial: Prediction and Predicament – Complications after ILND for Penile cancer

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In the current issue of BJUI, Gopman et al. [1] report the findings of an international multicentre study examining postoperative complications after inguinal lymph node dissection (ILND) for penile cancer. Their study is the largest to date, and despite its retrospective nature, provides detailed insight into this complex and morbid procedure.

ILND is a critical step in penile cancer treatment, and according to the guidelines of the European Association of Urology, is warranted when the clinical suspicion of lymph node invasion arises [2]. ILND helps to refine pathological staging and has been incorporated into prognostic tools estimating cancer-specific survival after treatment [3]. Despite clinical necessity, ILND is associated with exceptionally high complication rates, as reflected by the current studies’ 55.4% postoperative complication rate. As expected, most of the complications were due to wound complications. Although the authors recognised a decrease in major wound infections after 2008, the overall rate of morbidity after ILND for penile cancer has not changed substantially when compared with historical series [4].

The process of care for these patients can be long and tedious; it affects the personal well-being of the patient and is also responsible for a heavy societal financial burden [5]. The results of the current retrospective analysis are particularly sobering, given that the current data are exclusively from centres specialising in the care of patients with penile cancer. The number of unreported complications at lower volume centres may well be much higher than those evidenced by Gopman et al. [1].

So what can we do to improve our surgical results? The study by Gopman et al. [1] provides us with some tools for advancement. They found that the numbers of removed lymph nodes was a predictor for overall complications in their cohort. Specifically, higher pathological stages were accountable for all wound infections, while age and sartorius flap transposition affected major wound infections significantly. Unfortunately, the study could not provide granular information on preoperative comorbidities, e.g. diabetes mellitus, chronic steroid use and smoking status among others, which could have offered a deeper understanding of the determinants of complication.

Nonetheless, the authors are to be commended for their efforts to provide the urological community with the best available evidence, collected thus far, about complications of ILND for penile cancer. The rarity of penile cancer may limit a clinician’s ability to perceive the early warning signs of a deviation from the routine postoperative course. As such, the current study will not only help us to better counsel our patients but may also help raise our postoperative awareness of complications, thereby achieving improvements in operative outcomes.

Read the full article
Christian P. Meyer*†, Julian Hanske*‡ and Jesse D. Sammon*§

 

*Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, †Department of Urology, University Hospital Hamburg- Eppendorf, Hamburg, ‡Department of Urology, Marien Hospital, Ruhr-University Bochum, Herne, Germany and §VUI Center for Outcomes Research Ana lytics and Evaluation, Henry Ford Hospital, Detroit, MI, USA

 

References
1 Gopman JM, Baumgarten AS, Espiritu PN et al. Predicting postoperative complications of inguinal lymph node dissection for penile cancer in an international multicentre cohort. BJU Int 2015; 116: 196–201

 

2 Hakenberg OW, Comperat EM, Minhas S, Necchi A, Protzel C, Watkin N. EAU guidelines on penile cancer: 2014 update. Eur Urol 2014; 67: 142– 50

 

3 Sun M, Djajadiningrat RS, Alnajjar HM et al. Development and external validation of a prognostic tool for prediction of cancer-specific mortality after complete loco-regional pathological staging for squamous cell carcinoma of the penis. BJU Int 2014. [Epub ahead of print]. DOI: 10.1111/bju.12677

 

4 Ravi R. Morbidity following groin dissection for penile carcinoma. Br J Urol 1993; 72: 941–5

 

5 Drew P, Posnett J, Rusling L, Wound Care Audit Team. The cost of wound care for a local population in England. Int Wound J 2007; 4: 149–55

 

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