Tag Archive for: randomized controlled trial


Editorial: Ureteroscopy vs miniaturized percutaneous nephrolithotomy: what and who are we comparing?

We read with interest the article by Zeng et al. [1] comparing super‐mini percutaneous nephrolithotomy (SMP) with ureteroscopy (URS) for treatment of 1–2‐cm lower pole renal calculi. In this prospective randomized controlled trial, SMP achieved significantly higher stone‐free rates (SFRs) than URS on first‐day KUB with ultrasonography (91.2% vs 71.2%) as well as on 3‐month CT (93.8% vs 82.5%). Haemoglobin drop and pain score were higher in the SMP group, although no blood transfusions were required in either group. We congratulate the authors for this well conducted multicentre study and for the comprehensive report of their results.

A few comments are worth making to aid correct interpretation of the data presented in this study. First, it remains unclear whether the superiority of SMP over URS in terms of SFR was inherent to operating techniques, or whether this might have been the result of superior skills and interest of the surgeons favouring SMP. Surgeons were (obviously) not blinded to operating technique, which could have led to a bias. No study available in the literature has yet questioned whether a surgeon might be better at one technique (SMP or URS) than another. Ultimately, results may differ if both techniques were compared between two expert centres dedicated to each technique, respectively.

Second, the study protocol allowed surgeons to leave fragments up to 2 mm at the end of URS procedures. Strikingly, ‘stone‐free’ status was defined as residual fragments ≤3 mm. This methodology may well have affected the results, as neither endoscopy, KUB, ultrasonography nor CT is precise enough to differentiate 2‐mm from 3‐mm fragments [2, 3]. Arguably, this might have contributed to a lower SFR in the URS group.

Third, the study protocol did not clearly describe indications and choices for auxiliary procedures. Consequently, four of seven SMP (57.1%) and 19 of 23 URS patients (82.6%) with ‘clinically significant’ residual fragments were offered auxiliary procedures such as SMP, shockwave lithotripsy or external physical vibration lithecbole. Remarkably, none of the patients in the URS arm was offered any second‐look intervention, while this was the case in the SMP group.

Fourth, achievements made in one country may not be transposable to others, as epidemiology of urinary stone disease, demographic characteristics, access to technologies and education differ from one country to another. This has been acknowledged by the authors, and it seems particularly important to recall the relatively low body mass index (BMI) found in this cohort (mean BMI < 25 kg/m2). Higher BMI values may arguably impact on outcomes of SMP.

We agree with the authors that both SMP and URS are safe and feasible treatment options for lower pole calculi. Importantly, expertise in percutaneous surgery is warranted for cases presenting impaired retrograde access. Nevertheless, in light of constant and rapid advances in the field of URS, it seems that superiority, if any, of percutaneous nephrolithotomy in terms of SFR is to be tackled by URS in the years to come. This is well illustrated in the present study where 1–2‐cm stones were treated by URS with a laser power range between 5 and 20 W within 52 min in 50% of all cases and within 75 min in 86.4% of all cases (calculations based on values from Table 2 [1]).

Notably, no consensus has been agreed for the definition of different sizing of percutaneous nephrolithotomy instruments [4]. In the present study, the authors refer to SMP as the use of maximal tract dilation and instrument size up to 14 F. The authors justify size reduction of instruments considering the possible reduced blood loss in favor of smaller access sheaths compared with conventional percutaneous nephrolithotomy [5]. Nevertheless, it should be recalled that whether conventional, mini, super‐mini or any other‐size percutaneous nephrolithotomy, these techniques all share the same fundamental methods of access to intrarenal cavities; therefore, their inherent potential risks and harms – particularly bleeding and iatrogenic organ injury – fundamentally remain the same. This might partly explain why solitary kidney was an exclusion criterion in this study. In contrast, URS respects the delineation of the urinary tract [6]. URS is therefore likely to maintain a superior safety profile, even if further efforts are made at reducing the size of percutaneous nephrolithotomy instruments in the years to come.

The authors’ statement that SMP is more effective than URS to treat 1–2‐cm lower pole calculi should be interpreted in the context of the above. We hope that our comments will aid the correct interpretation of the data presented in this study. We congratulate the authors for the originality of their study, and we encourage them to continue evaluating indications, efficiency and safety of SMP.


  1. Zeng G, Zhang T, Agrawal M et al. Super‐mini percutaneous nephrolithotomy (SMP) vs retrograde intrarenal surgery for the treatment of 1‐2 cm lower‐pole renal calculi: an international multicentre randomised controlled trial. BJU Int 2018; 122: 1034–40
  2. Kishore TA, Pedro RN, Hinck B, Monga M. Estimation of size of distal ureteral stones: noncontrast CT scan versus actual size. Urology 2008; 72: 761–4
  3. Zhu W, Liu Y, Liu L et al. Minimally invasive versus standard percutaneous nephrolithotomy: a meta‐analysis. Urolithiasis 2015; 43: 563–70
  4. Giusti G, Proietti S, Villa L et al. Current standard technique for modern flexible ureteroscopy: tips and tricks. Eur Urol 2016; 70: 188–94


Article of the Month: ProCare Trial

Every Month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer

Jon D. Emery*,,, Michael Jefford§,¶, Madeleine King**,††, Dickon Hayne‡‡,§§, Andrew Martin¶¶, Juanita Doorey, Amelia Hyatt, Emily Habgood*, Tee Lim***Cynthia Hawks‡‡,§§, Marie Pirotta*, Lyndal Trevena††† and Penelope Schoeld§,¶,‡‡‡


*Department of General Practice, University of Melbourne, Carlton, Western Health and the Victorian Comprehensive Cancer Centre, Melbourne, Vic., School of Primary Aboriginal and Rural Health Care, University of Western Australia, Crawley, WA, §Sir Peter MacCallum Department of Oncology, Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Parkville, Department of Cancer Experiences Research, Peter MacCallum Cancer Centre, East Melbourne, Vic., **Quality of Life Ofce, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, ††Sydney Medical School, University of Sydney, Sydney, NSW, ‡‡School of Surgery, University of Western Australia, Crawley,WA, §§Department of Urology, Fiona Stanley Hospital, Perth, WA, ¶¶NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, ***Genesis Cancer Care, Department of Radiation Oncology, Fiona Stanley Hospital, Perth, WA, †††Primary Health Care, Sydney School of Public Health, University of Sydney, Sydney, NSW, and ‡‡‡Department of Psychology, Swinburne University of Technology, Melbourne, Vic., Australia


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To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer.

Patients and Methods

Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use.



A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91–554]).


Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost.

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Editorial: Rethinking cancer surveillance with shared-care models and survivorship plans: the time is now!

Urologists are increasingly facing significant practice concerns related to timely access, surgeon availability, clinical throughput and rising cost of care, yet little has changed over the years regarding the routine postoperative surveillance of urological cancers. While urologists have appropriately focused evaluations on oncological outcomes and procedure-specific quality-of-life concerns, the ability to maintain this practice model in the setting of more new patients (and subsequently more cancer survivors) seems unrealistic. In addition, gaps exist with the current model related to timely and effective communication to the local care team and assurances that specialists comprehensively address all concerns raised by patients. Furthermore, the role of the local care team in cancer survivorship remains poorly defined. Recognising these and other unmet needs in cancer care survivorship, the American Cancer Society (ACS) and the American Society of Clinical Oncology (ASCO) recently published guidelines on cancer survivorship [1-3]. The guidelines recommend a standardised approach to follow-up with emphasis on quality, comprehensive patient assessments, value, and shared use of a multidisciplinary team. With prostate cancer survivorship, for instance, ASCO recommends PSA checks every 6–12 months for the first 5 years and then annually (higher-risk patients can have more frequent checks), adherence to ACS guidelines for early detection of prostate cancer, assessment of physical and psychological effects of prostate cancer and it’s treatments, and annual assessments for long-term or late side-effects [3]. To help with the coordination of care between the patient, the oncological specialist, and the local primary care provider, survivorship care plans have been developed. [4]. While use of survivorship care plans has been sparse in urology to date, new mandates will spur their use in the coming years and development will likely involve innovative healthcare delivery solutions.

Leading the way in this nascent field, Emery et al. [4] report, in this issue of BJUI, an innovative phase II prospective randomised study on the feasibility of a novel shared-care model for follow-up of patients with prostate cancer. Men who had completed treatment for low- and moderate-risk prostate cancer were randomised to undergo usual care or shared care with the assistance of the patient’s primary care team. The novel shared-care model substituted two postoperative urology visits with three postoperative visits in primary care, provided patients and primary care providers a survivorship care plan, included appointment reminders, and provided a novel mechanism to screen for distress and other unmet needs. Among the 88 men randomised in the prospective study, no significant differences were noted between delivery models for satisfaction of care, overall quality of life, incidence of distress, or compliance with serum PSA testing. Patients in the shared-care model were significantly more likely to prefer the new model compared to normal care (cases, 63% vs controls, 24%, P < 0.001). Importantly, the shared-care model was also more economical, saving 323 Australian dollars compared to usual care [4].

The authors should be congratulated for their well-designed study and early contribution to the field. Rethinking all aspects of care delivery will become increasingly important as the practice of urology responds to access limitations, the shortage of urologists, and financial pressures of value-based reimbursement. The report also engenders many questions about the ideal care model of the future, composition of the collaborative care team, and the importance of making evidence-based clinical recommendations. For instance, are already overburdened primary care providers ideal or realistic in shared-care models? Should care remain primarily under the control of urologist with assistance provided by other current (e.g. advance practice providers, urology nurses) or future team member roles (e.g. survivorship care coordinators)? What role can the patient alone play in a self-guided survivorship care plan under the watchful eye of the collaborative care team acting asynchronously? How can enabling technologies such as smartphones, mobile applications, wearables, and video-conferencing contribute to high-value cancer surveillance building upon the principles highlighted in the current article and further engaging patients in their cancer survivorship care? [5]. Lastly, what actually are the evidence-based imperatives of survivorship care (what risk groups, what testing intervals and duration of testing) that provide measurable value to the patient experience? In the current study [4], for instance, high risk patients were excluded but ultimately these patients may be best suited for comprehensive survivorship care. Future work on survivorship and care models will hopefully continue to advance ‘win-win’ situations where patients and providers alike experience increasingly high-value systems of healthcare delivery.

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Matthew T. Gettman


Mayo Clinic Department of Urology, 200 First Street, SW, Rochester, MN 55905, USA




1 Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK , Wollins DS, Shulman LN. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning. J Oncol Pract 2014; 10: 34551


2 Skolarus TA, Wolf AM, Erb NL et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin 2014; 64: 22549





Article of the week: No difference in sexual function seen between monopolar and bipolar TURP

Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Bipolar vs monopolar transurethral resection of the prostate: evaluation of the impact on overall sexual function in an international randomized controlled trial setting

Charalampos Mamoulakis1,2, Andreas Skolarikos3, Michael Schulze4, Cesare M. Scoffone5, Jens J. Rassweiler4, Gerasimos Alivizatos3, Roberto M. Scarpa5 and Jean J.M.C.H. de la Rosette1

1Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands, 2Department of Urology, University Hospital of Heraklion, University of Crete Medical School, Heraklion, Crete, Greece, 3Second Department of Urology, Sismanoglio Hospital, University of Athens Medical School, Athens, Greece, 4Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany, and 5Department of Urology, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy

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• To compare monopolar and bipolar transurethral resection of the prostate (M-TURP and B-TURP, respectively) using a true bipolar system, for the first time in an international multicentre double-blind randomized controlled trial focusing on the overall sexual function quantified with the International Index of Erectile Function Questionnaire (IIEF-15). Other baseline/perioperative parameters potentially influencing erectile function (EF) after TURP were secondarily investigated.


• From July 2006 to June 2009, consecutive TURP candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into M-TURP/B-TURP arms and followed up at 6 weeks, 6 and 12 months after surgery. In all, 295 eligible patients were enrolled.

• Overall sexual function was quantified using self-administered IIEF-15 at baseline and at each subsequent visit.

•  Total IIEF/domain scores were calculated and EF score classified erectile dysfunction severity. Differences in erectile dysfunction severity at each visit compared with baseline (EF evolution), classified patients into ‘improved’, ‘stable’ or ‘deteriorated’.

•  Pre-postoperative IIEF/domain scores and differences in the distribution of EF evolution were compared between arms throughout follow-up.


• In all, 279 patients received the allocated intervention; 218/279 patients (78.1%) provided complete IIEF-15 data at baseline and were considered in sexual function analysis. Complete IIEF-15 data were available from 193/218 (88.5%), 186/218 (85.3%) and 179/218 (82.1%) patients at 6 weeks, 6 months and 12 months, respectively.

• Sexual function did not differ significantly between arms during follow-up (scores: IIEF, P = 0.750; EF, P = 0.636; orgasmic function, P = 0.868; sexual desire, P = 0.735; intercourse satisfaction, P = 0.917; overall satisfaction, P = 0.927).

• Resection type was not a predictor of any sexual function changes observed.

• Distribution of EF evolution did not differ between arms at any time (M-TURP vs B-TURP at 12 months: improved, 23/87 [26.4%] vs 18/92 [19.6%]; stable, 53/87 [60.9%] vs 56/92 [60.8%]; deteriorated, 11/87 [12.7%] vs 18/92 [19.6%]; P = 0.323).


• There were no differences between M-TURP/B-TURP in any aspect of sexual function.


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Editorial: Equivalent outcomes for monopolar and bipolar TURP; but are we overlooking the potential for improvement in sexual function after surgery?

Both BPH and sexual function (SF) have a major impact on quality of life in older men. Sexual dysfunction is a complex process encompassing both erectile and ejaculatory dysfunction, as well as reduced libido and difficulty achieving orgasm. Whilst retrograde ejaculation is an almost inevitable consequence of TURP, the evidence that TURP causes erectile dysfunction is conflicting. This is probably attributable, at least in part, to a lack of high-quality historical data. Studies now show that LUTS is a risk factor for sexual dysfunction, and we are becoming increasingly aware of the relationship that exists between LUTS, depression and sexual dysfunction.

Given the favourable safety profile of bipolar TURP (b-TURP), it is perhaps a surprise that this latest study from Mamoukalis et al. has failed to demonstrate any difference in outcomes with regard to the deterioration in SF after surgery. The authors should be praised for their attempts to examine in fine detail (using the International Index of Erectile Function [IIEF]-15 in this case) any potential differences between b-TURP and monopolar TURP (m-TURP).

The design of the bipolar system is such that tissue is removed at a lower temperature and therefore the likelihood of damage to surrounding tissues and nerves is reduced. Several randomized trials have compared b-TURP with m-TURP, but only a small number have looked specifically at sexual variables in a randomized setting. This multicentre study by Mamoukalis et al. randomized 279 men to one of the two resection techniques, looking specifically at overall SF quantified by the IIEF-15. No differences were detected in any aspect of SF; erectile function (EF) improved in 26.4% of patients in the m-TURP group compared with 19.6% in the b-TURP group, and remained stable in 60.9 and 60.8% of patients, respectively. A deterioration in EF was apparent in 12.7% of the m-TURP group compared with 19.6% of the b-TURP group (P = 0.323). These results mirror those of a similar randomized study by Akman et al. comparing a quasi-bipolar system with m-TURP. They demonstrated equivalence for all measured variables except for operating time and a 1.4% incidence of TUR syndrome in the m-TURP group. In their study, the EF domain of the IIEF-15 was measured before and after surgery. EF worsened in 17% of men, improved in 28.2% and was unchanged in 54.8%. A comparative evaluation of EF was performed in a sub-group of 188 sexually active non-catheterized men of whom 18.2% developed de novo erectile dysfunction.

The explanation for the equivalent outcomes is unclear and further investigation is required. Does the failure of bipolar TURP to demonstrate a benefit with regard to SF leave the door open for the competing minimally invasive laser technologies? The overall impact of the holmium laser compared with that of TURP appears to be equivalent, with a mean of 7.5 and 7.7% of patients reporting decreased erectile function, and 7.1 and 6.2% of patients reporting increased function after each surgery. From the data available thus far, it would also appear that photoselective vaporization of the prostate similarly has no overall deleterious impact on SF when compared with TURP in a randomized trial. Further randomized data are pending and are of course of great importance if we are to understand better how the procedures we perform for symptomatic BPH affect our patients. As technological advances are made the hope is that the ‘damaging’ effects of BPH surgery on overall SF (particularly EF) will reduce further, but it may indeed be that we are searching for small margins when our attention might be better focused on maximizing the likelihood of a positive outcome, facilitated by considering the preoperative status (general health as well as urinary and sexual function), aided by the use of validated questionnaires. A better appreciation and understanding of the factors that may increase the risk of ED after surgery (age, diabetes, metabolic syndrome, obesity, cardiovascular disease and psychological factors) will enable us to manage expectations more effectively. A shorter hospital stay with minimal postoperative discomfort and an early return to normal activities, coupled with good symptomatic improvement in the longer term can only serve to be of benefit with regard to improving SF outcomes.

One recent study reporting both the short-, medium- and long-term effects of TURP on SF highlighted the high incidence of LUTS before treatment with 57% overall reporting ED before surgery. Those with severe LUTS were much more likely to have significant sexual dysfunction before surgery. This study also demonstrated a 15% improvement in pre-existing ED which was related to the improvement in LUTS after TURP.

On reflection, therefore, it would seem reasonable to conclude from the evidence presented that, although retrograde ejaculation frequently occurs after outflow surgery, erectile function is as likely to improve as it is to deteriorate. By focusing on the specific patient characteristics for each individual case before surgery it is possible we can improve the proportion of patients achieving a favourable outcome. When counselling patients before surgery regarding SF we should therefore remember to include the potential benefits as well as the risks. Furthermore, for those patients particularly anxious about the possibility of worsening SF, a ‘lesser’ surgical procedure, which might not achieve a transurethral resection-like cavity should perhaps be considered as a compromise. However, a surgical alternative which is not equivalent to TURP may indeed reduce the likelihood of improving erectile function, given the interrelationship that appears to exist between LUTS and SF.

Richard Hindley
Department of Urology, Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hampshire, UK.

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