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Article of the Month: GreenLight XPS for treating benign prostatic hyperplasia

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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.

GreenLight XPS for treating benign prostatic hyperplasia

Read the full article

This National Institute for Health and Care Excellence (NICE) guidance is the current, unaltered NICE guidance at time of publication. BJUI publishes selected NICE guidance relevant to urologists to extend their distribution and promote best practice.

 

 Recommendations

  • 1.1
    The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.

 

  • 1.2

    There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:

    • have an increased risk of bleeding or
    • have prostates larger than 100 ml or
    • have urinary retention.

    NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

 

  • 1.3
    Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.

 

  • 1.4
    NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.

 

Read more articles of the week

 

Editorial: Celebrating BAUS and NICE Guidance

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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 O’Flynn

 

President of the BAUS

 

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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;119:823–30

 

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

 

Residents’ Podcast: NICE Guidance – GreenLight XPS for treating benign prostatic hyperplasia

/1 Comment/by

Veeru Kasivisvanathan

SpR in Urology & NIHR Doctoral Fellow, University College London & University College Hospital London.

Read the full article

This National Institute for Health and Care Excellence (NICE) guidance is the current, unaltered NICE guidance at time of publication. BJUI publishes selected NICE guidance relevant to urologists to extend their distribution and promote best practice.

 Recommendations

  • 1.1
    The case for adopting GreenLight XPS for treating benign prostatic hyperplasia is supported in non-high-risk patients. GreenLight XPS is at least as effective in these patients as transurethral resection of the prostate (TURP), but can more often be done as a day-case procedure, following appropriate service redesign.
  • 1.2

    There is currently insufficient high-quality, comparative evidence to support the routine adoption of GreenLight XPS in high-risk patients, that is those who:

    • have an increased risk of bleeding or
    • have prostates larger than 100 ml or
    • have urinary retention.

    NICE recommends that specialists collaborate in collecting and publishing data on the comparative effectiveness of GreenLight XPS for high-risk patients to supplement the currently limited published evidence.

  • 1.3
    Cost modelling indicates that in non-high-risk patients, cost savings with GreenLight XPS compared with TURP are determined by the proportion of procedures done as day cases. Assuming a day-case procedure rate of 36%, and that the GreenLight XPS console is provided at no cost to the hospital (based on a contracted commitment to fibre usage), the estimated cost saving is £60 per patient. NICE’s resource impact report estimates that the annual cost saving for the NHS in England is around £2.3 million. In a plausible scenario of 70% of treatments being done as day cases, the cost saving may be up to £3.2 million.
  • 1.4
    NICE recommends that hospitals adopting GreenLight XPS plan for service redesign to ensure that day-case treatment can be delivered appropriately.
Read more articles of the week

Article of the Week: TRT and rates of PCa or LUTS

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Every Week the Editor-in-Chief selects an 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.

Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men

Frans M.J. Debruyne*, Hermann M. Behre†, Claus G. Roehrborn‡, Mario Maggi§, Frederick C.W. Wu, Fritz H. Schroder**, Thomas Hugh Jones††, Hartmut Porst‡‡, Geoffrey Hackett§§, Olivia A. Wheaton¶¶, Antonio Martin-Morales***, Eric J. Meuleman†††, Glenn R. Cunningham‡‡‡, Hozefa A. Divan¶¶ and Raymond C. Rosen ¶¶ for the RHYME Investigators

 

*Andros Men’s Health Institutes, Arnhem, The Netherlands, †Center for Reproductive Medicine and Andrology, Martin Luther University Halle-Wittenberg, Halle, Germany, ‡Southwestern Medical Center, University of Texas, Dallas, TX, USA, §Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy, ¶ University of Manchester, Manchester, UK, **Erasmus Medical Center, Rotterdam, The Netherlands, ††Barnsley Hospital NHS Foundation Trust, Barnsley, UK, ‡‡Private Practice of Urology/Andrology, Hamburg, Germany, §§Holly Cottage Clinic, Lichfield, Staffordshire, UK, ¶¶New England Research Institutes, Inc., Watertown, MA, USA, ***Carlos Haya University Hospital, Malaga, Spain, †††VU Medical Center, Amsterdam, The Netherlands, and ‡‡‡Baylor College of Medicine, St. Luke’s Episcopal Hospital, Houston, TX, USA

 

 
Read the full article

Abstract

Objectives

To evaluate the effects of testosterone-replacement therapy (TRT) on prostate health indicators in hypogonadal men, including rates of prostate cancer diagnoses, changes in prostate-specific antigen (PSA) levels and lower urinary tract symptoms (LUTS) over time.

Patients and Methods

The Registry of Hypogonadism in Men (RHYME) is a multi-national patient registry of treated and untreated, newly-diagnosed hypogonadal men (n = 999). Follow-up assessments were performed at 3–6, 12, 24, and 36 months. Baseline and follow-up data collection included medical history, physical examination, blood sampling, and patient questionnaires. Prostate biopsies underwent blinded independent adjudication for the presence and severity of prostate cancer; PSA and testosterone levels were measured via local and central laboratory assays; and LUTS severity was assessed via the International Prostate Symptom Score (IPSS). Incidence rates per 100 000 person-years were calculated. Longitudinal mixed models were used to assess effects of testosterone on PSA levels and IPSS.

feb-aotw-2-results

Results

Of the 999 men with clinically diagnosed hypogonadism (HG), 750 (75%) initiated TRT, contributing 23 900 person-months of exposure. The mean testosterone levels increased from 8.3 to 15.4 nmol/L in treated men, compared to only a slight increase from 9.4 to 11.3 nmol/L in untreated men. In all, 55 biopsies were performed for suspected prostate cancer, and 12 non-cancer related biopsies were performed for other reasons. Overall, the proportion of positive biopsies was nearly identical in men on TRT (37.5%) compared to those not on TRT (37.0%) over the course of the study. There were no differences in PSA levels, total IPSS, or the IPSS obstructive sub-scale score by TRT status. Lower IPSS irritative sub-scale scores were reported in treated compared to untreated men.

Conclusions

Results support prostate safety of TRT in newly diagnosed men with HG.

 

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Editorial: Mythology and Reality Should Never Be Confused (But Often Are)

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The debating halls of learned urological societies often attempt to define theories based on little substance. Unfortunately, although this type of scientific discourse should be encouraged, it can create both content for unrepeatable ‘late breaking’ abstracts and headlines for mass circulation newspapers. Once started, the momentum can make a perception become a ‘reality’ that is invariably difficult to dislodge. An area of particular current interest to both the scientific and lay press, and indeed the regulatory authorities in the USA and the European Union, is testosterone replacement. Within this context, an important potential myth-buster is described in the article by DeBruyne et al. [1]. The hypothesis (aka myth) that was being examined was that application of exogenous testosterone, irrespective of formulation, could exacerbate both benign and malignant prostatic disease. To understand the importance of this type of definitive study we must start at the beginning.

The foundation of the mythology, or in reality a Canadian-US urological tragedy, was ironically in the Nobel Prize winning work of Charles B Huggins. The ‘good news’ was that prostatic tumour regression could be affected by androgen deprivation, a finding certainly worthy of global recognition and acceptance; however, this became embellished to a certain extent, incorporating other aliquots of somewhat circumstantial evidence, leading to a suggestion that testosterone replacement could increase the probability and/or rate of prostate cancer progression. As a result, various societies perhaps understandably adopted their normal conservative approach of inserting a warning (with varying degrees of emphasis) in their guidelines [2]. Over the last decade, with the increasing use of testosterone replacement in the treatment of men with hypogonadism, the issue of benefit–risk has become more relevant, indeed is often transposed to risk–benefit, and is increasingly likely to feature in the popular press. Within the last couple of years, we have seen the spectre of testosterone and cardiovascular risk played out in full public view, but the issue of testosterone and exacerbation of prostatic disease has continued to smoulder in the background.

The RHYME study [1], although it is largely confirmatory as other studies have described similar conclusions, is of considerable ‘real-life’ value. The power of the study is that it should be considered to be representative of the potential hypogonadal population likely to present to the physician. Although not used for regulatory approval purposes, a registry study is considered to be the ‘gold standard’ for this type of analysis. So what are the conclusions of this and the majority of other studies? In essence, there is no evidence that restoration of testosterone to the normal range does increase the incidence or progression of either benign (BPH) or malignant prostatic disease. Any slight changes in PSA level were considered not to be clinically relevant and likely to be as a consequence of the direct pharmacology of increased testosterone levels [3]. This does not imply that exacerbations will never be seen or that appropriate monitoring should not be carried out; more that the conventional wisdom on testosterone and prostatic disease has gone (or should go) the way of antimuscarinic agents, invariably causing urinary retention in patients with BPH. It is to be hoped that studies such as the RHYME study will continue to be undertaken and help provide perspective for specialist and primary care physicians alike in areas of emergent clinical interest.

Read the full article
Michael Wyllie
Global Pharma Consulting Ltd, Stratton House, Shenington, Banbury, Oxfordshire

 

References

 

1 Debruyne FMJ, Behre HM, Roehrborn CG et al. Testosterone treatment is not associated with increased risk of prostate cancer or worsening of lower urinary tract symptoms: prostate health outcomes in the Registry of Hypogonadism in Men (RHYME). BJU 2017; 119: 216–24

 

2 Bhasin S, Cunningham GR, Hayes FJ et al. Testosterone therapy in men with androgen deficiency syndromes: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2010; 95: 2536–59

 

3 Boyle P, Koechlin A, Bota M, D’Onofrio A et al. Endogenous and exogenous testosterone and the risk of prostate cancer and increased prostate specific antigen (PSA) level: a meta-analysis. BJU Int 2016; 118: 731–41

 

Article of the Week: eNOS G894T gene polymorphism and responsiveness to a selective α1-blocker in BPH/LUTS

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Every Week the Editor-in-Chief selects an 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.

The association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective α1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms

Yung-Chin Lee*,†, Yung-Shun Juan*,†,‡, Chia-Chu Liu*,†,§, Bo-Ying Bao,**,††, Chii-Jye
Wang*,†, Wen-Jeng Wu*,†, Chun-Nung Huang*,† and Shu-Pin Huang*,†,‡‡
*Department of Urology, †Department of Urology, Faculty of Medicine, Kaohsiung Medical University, ‡Department of Urology, Kaohsiung Municipal Hsiao-Kang Hospital, Kaohsiung, §Department of Health, Executive Yuan, Pingtung Hospital, Pingtung,

 

Department of Pharmacy, **Sex Hormone Research Center, China Medical University Hospital, ††Department of Nursing, Asia University, Taichung, and ‡‡Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
Read the full article

Objective

To prospectively investigate the association of endothelial nitric oxide synthase (eNOS) G894T gene polymorphism with responsiveness to a selective α1-blocker in men with benign prostatic hyperplasia related lower urinary tract symptoms (BPH/LUTS), as nitric oxide has recently gained increasing recognition as an important neurotransmitter of functions in the lower urinary tract.

Patients and Methods

In all, 136 men with BPH/LUTS were recruited from urology outpatient clinics in a university hospital. Oral therapy with doxazosin gastrointestinal therapeutic system (GITS) 4 mg once-daily was given for 12 weeks. The drug efficacy was assessed by the changes from baseline in the total International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax) and post-void residual urine volume (PVR) at 12 weeks of treatment. The ‘responders’ to doxazosin GITS were defined as those who had a total IPSS decrease of >4 points from baseline. eNOS G894T polymorphism was determined using the polymerase chain reaction-restriction fragment length polymorphism method.

AugAOTW2

Results

Patients had statistically significant improvements in total IPSS, quality of life score, and Qmax (P < 0.01) after a 12-week period of treatment. Using multiple logistic regression analysis adjusted for age and IPSS, our results showed that being a eNOS 894T allele carrier was an independent risk factor for being a drug non-responder (P = 0.03, odds ratio 4.19). Moreover, a decreased responder rate (P = 0.01), as well as the lower improvements in IPSS (P = 0.02) and Qmax (P = 0.03) were significantly associated with increment in the T allele number.

Conclusions

The presence of the eNOS 894T allele had a significantly negative impact on responsiveness to a selective α1-blocker in BPH/LUTS treatment, suggesting that eNOS G894T gene polymorphism may be a genetic susceptibility factor for α1-blocker efficacy in men with BPH/LUTS.

Read more articles of the week

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

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

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

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

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

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

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

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

 

References

 

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

 

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

 

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

 

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

 

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

 

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

 

Video: Aquablation – image-guided robot-assisted waterjet ablation of the prostate

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Aquablation – image-guided robot-assisted waterjet ablation of the prostate: initial clinical experiences

Peter Gilling, Rana Reuther, Arman Kahokehr and Mark Fraundorfer

 

Department of Urology, Tauranga Hospital, Tauranga, New Zealand

 

Read the full article

Objective

To assess the safety and feasibility of aquablation in a first-in-man study. Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics (aquabeam®) for the targeted and heat-free removal of prostatic tissue in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

A prospective, non-randomised, single-centre trial in men aged 50–80 years with moderate-to-severe LUTS was conducted. Under real-time image-based ultrasonic guidance, aquabeam technology enables surgical planning and mapping, and leads to a controlled heat-free resection of the prostate using a high-velocity saline stream. Patients were evaluated at 1, 3, and 6 months after aquablation.

Results

In all, 15 patients were treated with aquablation under general anaesthesia. The mean (range) age was 73 (59–86) years and prostate size was 54 (27–85) mL. A substantial median lobe was present in six of the 15 patients. The mean International Prostate Symptom Score (IPSS) was 23 and the maximum urinary flow rate (Qmax) was 8.4 mL/s at baseline. The mean procedural time was 48 min with a mean aquablation treatment time of 8 min. All procedures were technically successful with no serious or unexpected adverse events (AEs). All but one patient had removal of catheter on day 1, and most of the patients were discharged on the first postoperative day. No patient required a blood transfusion, and postoperative sodium changes were negligible. There were no serious 30-day AEs. One patient underwent a second aquablation treatment within 90 days of the first procedure. The mean IPSS score statistically improved from 23.1 at baseline to 8.6 at 6 months (P < 0.001) and the Qmax increased from 8.6 mL/s at baseline to 18.6 mL/s at the 6-month follow-up (P < 0.001). At 6 months, the mean detrusor pressure at Qmax decreased to 45 cmH20 from 66 cmH20 at baseline (P < 0.05), and the mean prostate size was reduced to 36 mL, a 31% reduction in size vs baseline (P < 0.001). No cases of urinary incontinence or erectile dysfunction were reported.

Conclusions

These preliminary results from this initial study show aquablation of the prostate is technically feasible with a safety profile comparable to other BPH technologies. The combination of surgical mapping by the operating surgeon and the high-velocity saline provides a promising technique delivering a conformal, quantifiable, and standardised heat-free ablation of the prostate. Advantages of this technique include reduction in resection time compared with other endoscopic methods, as well as the potential to preserve sexual function.

 

Article of the Week: Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an alpha-blocker

/2 Comments/by

Every Week the Editor-in-Chief selects an 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.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Tae Heon Kim, discussing his paper. 

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

Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an alpha-blocker in men with lower urinary tract symptoms (LUTS) and overactive bladder: a randomized controlled trial

Tae Heon Kim*, Wonho Jung†, Yoon Seok Suh*, Soonhyun Yook‡, Hyun Hwan Sung* and Kyu-Sung Lee*‡
*Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, †Department of Urology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, and ‡Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea Tae Heon Kim and Wonho Jung contributed equally to this work.

 

Read the full article
Objective
To evaluate the efficacy and safety of low-dose (2 mg) tolterodine extended release (ER) with an a-blocker compared with standard-dose (4 mg) tolterodine ER with an α-blocker for the treatment of men with residual storage symptoms after α-blocker monotherapy.
Patients and Methods
The study was a 12-week, single-blind, randomized, parallel group, non-inferiority trial that included men with residual storage symptoms despite receiving at least 4 weeks of α-blocker
treatment. Inclusion criteria were total International Prostate Symptom Score (IPSS) ≥12, IPSS quality-of-life item score ≥3, and ≥8 micturitions and ≥2 urgency episodes per 24 h. The primary outcome was change in the total IPSS score from baseline. Bladder diary variables, patient-reported
outcomes and safety were also assessed.
feb-2-aotw-f1
Results
Patients were randomly assigned to addition of either 2 mg tolterodine ER (n = 47) or 4 mg tolterodine ER (n = 48) to α-blocker therapy for 12 weeks. Patients in both treatment groups had a significant improvement in total IPSS score (5.5 and 6.3, respectively), micturition per 24 h (1.3 and
1.7, respectively) and nocturia per night (0.4 and 0.4, respectively). Changes in IPSS, bladder diary variables, and patient-reported outcomes were not significantly different between the treatment groups. All interventions were well tolerated by patients.
Conclusions
These results suggest that 12 weeks of low-dose tolterodine ER add-on therapy is similar to standard-dose tolterodine ER add-on therapy in terms of efficacy and safety for patients experiencing residual storage symptoms after receiving α-blocker monotherapy.

 

Editorial: Should we start with low-dose anti-cholinergics when alpha-blockers alone fail?

/1 Comment/by

Kim et al. [1] asked the question whether we should start by treating men who have persistent storage LUTS despite α-blocker monotherapy, with a low-dose anti-cholinergic as opposed to the standard dose (given the potentially increased risk of side-effects such as acute urinary retention and high discontinuation rates with the standard dose). It is a valid question, for we know that discontinuation rates with standard doses of anti-cholinergics can be as high as 50% in the first 3 months due to a combination of ineffectiveness and side-effects [2]. However, the problem lies in the multifactorial nature of the causes of storage vs voiding LUTS, and the difficulty in assessing and distinguishing them accurately with our current tools.

The authors have conducted a randomised controlled trial of 2 mg vs 4 mg tolterodine added to the participants’ on-going α-blocker regime and selected reduction in total IPSS as their primary outcome measure. They have also assessed IPSS sub-scores, 3-day bladder diary variables, and the Patient Perception of Bladder Condition (PPBC) and Overactive Bladder (OAB-q) questionnaires, as secondary outcomes. As would be expected of a peer-reviewed publication the trial has been seemingly well conducted and fairly well reported. Recruitment met the requirement set by the power calculation based on a clinically significant difference of a 4-point drop in total IPSS, and the authors concluded that 2 mg tolterodine is not inferior to the 4 mg dose in achieving a significant reduction in total IPSS at 12 weeks. They also report no difference in patient perception of treatment benefit or satisfaction at this time point.

These results are interesting, especially considering some of the details of the study. First of all, patients were not on the same α-blocker at baseline; the most common was tamsulosin (62.8%), but alfuzosin, doxazosin, and others were also being used. This in itself may not be a problem because all patients continued on the same α-blocker through the study, and in fact this better represents real-world practice. However, the mean (sd) duration of α-blocker therapy at baseline was 9.1 (19.9) months. We know that α-blocker therapy can improve IPSS by up to 30–40% [3], but the pertinent question for this study is whether these patients had achieved this level of improvement initially then stabilised and improved no further, or whether they had no improvement at all? It could conceivably make a difference to participants approach to the IPSS if they were previously familiar with it and, more importantly, aware of their results. The Hawthorne effect, also known as the observer effect, and the related Heisenberg uncertainty principle, are factors that we must necessarily encounter in clinical trials but we sometimes fail to account for.

Another aspect of the study that warrants consideration is the choice of primary outcome itself. This is a particular bug-bear of mine and indeed has been commented on by many authors including in the European Association of Urology (EAU) guideline on urinary incontinence in relation to anti-muscarinics [4]. Outcomes that lend themselves to easier power calculations and statistically significant results have almost evolved to be ‘un’-naturally selected for the purpose of clinical trial primary outcome measures. Drug trials are especially notorious for this. Here again, the choice of the total IPSS to assess whether an anti-muscarinic will help improve persistent storage LUTS is a case in point. Not least because it renders the significance of all the secondary outcomes dependant on the same power calculation. It is no doubt convenient, but is it appropriate? It is easy to point the finger at trialists for this, but the business-like, ‘bottom-line’ nature of medical publishing and research today is equally, if not more, to blame.

Finally, I would like to call the reader’s attention to the difference in baseline urgency and urgency urinary incontinence (UUI) episodes. The author’s state there was no statistically significant difference, but one might argue that when assessing improvement in storage LUTS, a group with a mean (sd) baseline number of UUI episodes of 3.9 (8.6) may perceive improvement quite differently compared with a group with a baseline of 1.6 (1.1). This has borne out in the difference in the bladder diary outcome of UUI/24 h; significant improvement in the first group (who were wetter at baseline and got 4 mg tolterodine) but no difference in the latter group (comparatively drier and got 2 mg tolterodine). But almost paradoxically this does not seem to have made a difference to the patient-reported outcome measures. One possible explanation for this could be the relatively few patients who were incontinent at baseline.Overall this paper gives us a lot of food for thought. The direct result – should we indeed start men with persistent storage LUTS on low-dose anti-cholinergics rather than standard dose, and then titrate upwards? But it also challenges us to consider whether we simply accept researcher’s and sponsor’s decisions on outcome measures. What do you think? Do we simply sit back and accept what is put before us because statistics scares us a little? Or, as researchers and consumers of medical literature, do we struggle to make the hard choices, risk our results being rejected by the top journals, and stand up for good science?

Conflicts of Interest

The author has received a travel grant to attend an international conference from Ferring pharmaceuticals.

 

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Arjun K. Nambiar
Clinical Research Registrar
Department of Urology, Morriston Hospital, Abertawe Bro Morgannwg (ABM) University Local Health Board, Swansea, SA6 6NL, UK

 

References

 

1 Kim TH, Jung W, Suh YS, Yook S, Sung HH, Lee KS. Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an a-blocker in men with lower urinary tract symptoms (LUTS) and overactive bladder: a randomized controlled trial. BJU Int 2015; 117:  307–15
2 Lucas MG, Bedretdinova D, Berghmanset LC et al. Guidelines on Urinary Incontinence, Section 4.2.4. In: EAU Guidelines, edition presented at the 30th EAU Annual Congress, Madrid 2015. ISBN 978-90-79754-80-9. Available at: https://uroweb.org/wp-content/uploads/17-Urinary-Incontinence_LR.pdf. Accessed September 2015
3 Gravas S, Bach T, Bachmann A et al. Guidelines on Non-Neurogenic Male LUTS Including Benign Prostatic Obstruction, Section 3C.2. In: EAU Guidelines, edition presented at the 30th EAU Annual Congress, Madrid 2015. ISBN 978-90-79754-80-9. Available at: https://uroweb.org/wp-content/uploads/11-Male-LUTS_LR.pdf. Accessed September 2015
4 Lucas MG, Bedretdinova D, Berghmanset LC et al. Guidelines on Urinary Incontinence, Section 4.2.1. In: EAU Guidelines, edition presented at the 30th EAU Annual Congress, Madrid 2015. ISBN 978-90-79754-80-9. Available at: https://uroweb.org/wp-content/uploads/17- Urinary-Incontinence_LR.pdf. Accessed September 2015

 

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