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Transurethral resection, the mother of minimally invasive surgery in urology: beyond the gold standard
- Arun Sivanandam, MS, Mahendra Bhandari MS, MCho(Uro), FAMS, DSc(Hon) (10 July 2008)
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Transurethral resection is the gold standard
- Said Fadel Mishriki (14 July 2008)
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The Irreversible Tide of Technological Advancement?
- Hashim U Ahmed, Manit Arya (SpR Urology), Mark Emberton (Reader in Interventional Oncology and Honorary Consultant Urological Surgeon) (16 July 2008)
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Author’s reply to comments by Sivanandam and colleagues
- Tania Lourenco, Robert Pickard, Luke Vale, Adrian Grant, Cynthia Fraser, Graeme MacLennan, James N’Dow and the Benign Prostatic Enlargement team (16 July 2008)
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Is laser associated with more incontinence?
- John B Davies (19 July 2008)
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Author's reply to comments by Davies J.
- Tania Lourenco, Robert Pickard, Luke Vale, Adrian Grant, Cynthia Fraser, Graeme MacLennan, James N’Dow and the Benign Prostatic Enlargement team (23 July 2008)
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Arun Sivanandam, MS, Research Assistant Vattikuti Urology Institute, Henry Ford Hospital, Detroit MI 48202, Mahendra Bhandari MS, MCho(Uro), FAMS, DSc(Hon)
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We read with great interest the systematic review of randomized controlled trials (RCTs) by Lourenco et al. comparing newer methods for endoscopic ablation against the gold standard of transurethral resection of the prostate (TURP). While Holmium laser enucleation technology did show statistically significant improvements over TURP in outcome measures such as symptom scores, peak urinary flow rate, blood transfusion, and decreased hospital stay. However, any conclusion on the basis of above findings without concurrent measurement of cost benefit and its translation to clinical significance would be irrational. We cannot overlook the desperation of many commercial organizations that have spent large amounts of money in research and development of a variety of lasers touting innovation as hype over quality. TURP as a fall back procedure continues as a gold standard and thus we urge caution in interpreting studies involving new technologies. TURP represents the mother endourological procedure, a beginning point to hone hand-eye-foot coordination skills. As such, urologists need to spend extensive time and effort training with TURP, which may is not true with alternative endoscopic ablation technologies. Failing to correct for this possible confounding effect, the authors combine primary outcome data of different types for meta-analysis: International Prostate Symptom Score, American Urological Association Symptom Index and Danish Prostatic Symptom Score. It is unclear on what basis the authors decided to group all three sets of scores into one category for analysis without statistical comparison by methods such as chi-square test or ANOVA. Of particular interest, a few data points for different types of vaporisation techniques were reported as medians instead of means (Table 1). Methods used in statistical approximation of these points for further meta- analysis were not clear, although established procedures exist (1). In addition to concern for variation in studies of laser technologies in terms of unstandardized operational settings, the benefit of Holmium laser technology may have been overstated as a result of incomplete cost- benefit analysis. Specifically, a shorter hospital stay (1 day) compared to TURP has little clinical value as an isolated data point until readmission to the hospital and the period of catheterization of patients is also considered. Unfortunately, the hospital discharge is not coincident the wellbeing of the patient. Further to this, the authors do not consider the lack of marginalized benefit of blood loss by Holmium laser technology in conjunction with the establishment and the recurring leading to enormous per procedure costs (2). As such, this calls into question the applicability of these findings, especially in developing countries. In their discussion of study quality and reporting, Laurenco et al. bring up the possibility of selection and publication bias. We are at a loss to understand why they were unable to report on this estimation using the Egger regression asymmetry test and Funnel plot. Clearly, the lack of adequate high quality Level 1 evidence in terms of data-point reporting and randomization procedural considerations such as intent to treat places a major handicap in efforts to cull data for meta-analysis purposes and calls for an urgent imposition on the part of researchers and journal editors alike in the interests of continuity. References: 1. Hozo PS, Djulbegovic B, and Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Medical Research Methodology 2005; 5:13. 2. Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol 2008; 180:241-5. Competing interests: None declared |
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Said Fadel Mishriki, Consultant Urological Surgeon Aberdeen Royal Hospitals, Foresterhill, Aberdeen AB25 2ZN
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Transurethral resection of the prostate (TURP) should remain as the standard approach(1). However, setting the primary outcome measure as the change in symptom score at 12 months after surgery is unfortunate. The follow-up is too short to be meaningful(2). The longest prospective study due to be published assessing the outcome of TURP has established it as the gold standard. This milestone re-enforced that other ablative and minimally invasive procedures should be weighed against TURP(3). To compare the effectiveness of a procedure, long-term prospective cohort studies should be systematically reviewed and considered. 1. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials. Lourenco T, Pickard R, Vale L, Grant A, Fraser C, MacLennan G, et al. BMJ 2008;337: a450 page 36 2. Endoscopic ablation for benign enlargement of the prostate. Newer techniques are no better than transurethral resection, but the evidence base is poor. Elliott SP. BMJ 2008;337: a535 page 4 3. Improved Quality of Life and Enhanced Satisfaction After TURP: Prospective 12-Year Follow-up Study. Mishriki SF, Grimsley SJ, Nabi G, Martindale A, Cohen NP. Urology 2008 Jun 3. [Epub ahead of print] Competing interests: None declared |
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Hashim U Ahmed, MRC Clinical Research Fellow and Spr Urology University College London (W1P 7PN) and Imperial NHS Trust, UK, Manit Arya (SpR Urology), Mark Emberton (Reader in Interventional Oncology and Honorary Consultant Urological Surgeon)
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Dear Editor, Lourenco et al should be congratulated on an important systematic review comparing new ablative technologies in the management of benign enlargement of the prostate [1]. It seems to show the adoption of new technologies into medical practice over older tried and tested ones to be without justification from level 1 evidence [2]. This is not a unique situation to urology in which the adoption of laparoscopic and robotic prostatectomy has also been heavily criticised for adoption into mainstream [3]. There are a number of specific and general points to make. First, the authors contention that holmium laser enucleation holds most promise in challenging TURP belies the fact that this technique has a steep learning curve and requires careful morcellation of the prostate in the bladder once enucleated. Second, since the systematic review was carried out, photoselective vapourisation (PVP)(so-called Greenlight PVP laser of the prostate) has taken to the fore in many urology units. The short learning curve, day- case nature with minimal to no bleeding as well as ability to carry out ablation whilst patients are on anticoagulation have made this development in prostate management an extremely attractive option [4]. Two randomised controlled trials have reported on this comparing PVP against TURP, one with 6 months follow-up [5] and one with 12 months follow-up [6]. The latter showed equivalent flow-rate and symptom score outcomes, alongside shorter length of stay, length of catheterisation and adverse events. Third, many of these changes in medical practice are clearly driven by patient choice and the belief that new technologies, ‘keyhole surgery’, the ‘robot’ and ‘lasers’ hold advantage over traditional techniques and the willingness of medical practitioners to offer such treatment. Equally, whether all surgical advances and their adoption should be embedded in randomised trials when the results of those RCTs are not relevant at the time of reporting is arguable. The key question is whether this systematic review will aid in the reversal of this trend. Indeed, by virtue of the continuing annual advances in this field, can such systematic reviews which by their very nature, are 2-3 years out of date, ever have utility in such an area of medical practice. References 1. Lourenco T, Pickard R, Vale L, Grant A, Fraser C, MacLennan G, et al. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials. BMJ. 2008 Jun 30;337:a449. 2. Yu X, Elliott SP, Wilt TJ, McBean AM. Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies. J Urol 2008; 180:241-5. 3. Schwitzer GJ. Robotic prostatectomy: Data, please. BMJ. 2008;336(7648):790. 4. Ahmed HU, Thwaini A, Shergill IS, Hammadeh MY, Arya M, Kaisary AV. Greenlight prostatectomy: a challenge to the gold standard? A review of KTP photoselective vaporization of the prostate. Surg Laparosc Endosc Percutan Tech. 2007;17(3):156-63. 5. Horasanli K, Silay MS, Altay B, Tanriverdi O, Sarica K, Miroglu C. Photoselective potassium titanyl phosphate (KTP) laser vaporization versus transurethral resection of the prostate for prostates larger than 70 mL: a short-term prospective randomized trial. Urology. 2008;71(2):247-51. 6. Bouchier-Hayes DM, Anderson P, Van Appledorn S, Bugeja P, Costello AJ. J Endourol. 2006;20(8):580-5. KTP laser versus transurethral resection: early results of a randomized trial. Competing interests: None declared |
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Tania Lourenco, Research fellow University of Aberdeen, Health Services Research Unit, Robert Pickard, Luke Vale, Adrian Grant, Cynthia Fraser, Graeme MacLennan, James N’Dow and the Benign Prostatic Enlargement team
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We thank Dr Sivanandam and colleagues for commenting on our study[1] and agree that consideration of cost is an important aspect of assessing the worth of new procedures. We will shortly be submitting for publication an economic evaluation of these technologies in comparison to the standard of TURP which will help guide purchasers of health care. The degree of technical expertise and hence training required to undertake relatively complex endoscopic procedures such as TURP and HoLEP is certainly a cost factor and one of the stated advantages of vaporisation procedures is that a lesser degree of technical skill is required – this may be of benefit for communities with limited health care budgets. Despite the lack of cost data in the present article we do feel that consideration of safety and effectiveness alone remains valuable to both surgeons and patients. Prior to the start of the study, we developed a very detailed protocol which considered statistical methodologies such as those mentioned in Sivanandam’s response as well as outcomes over and above those reported in our study.[2] As with all systematic reviews we were constrained by the data available and the form in which it was presented in the original publications. In particular we were unable to consider outcomes such as well-being after discharge since they were not reported in the primary studies. Concerning publication bias, Sivanandam and colleagues suggest that this could be estimated by Egger regression asymmetry and Funnel plot but our understanding would be that more than ten studies need to be available for robust results from these methods, a criterion not achieved in our review. The use of median as a summary measure was only applicable to one study that would have been eligible to be included in our meta-analysis,[3] but unfortunately, as can be seen from our supplementary table, these data could not be used as the accompanying measures of uncertainty were inadequate. It should also be remembered that use of additional statistical procedures to include data whose derivation is unclear will tend to increase uncertainty regarding the results of meta-analysis. To clarify the issue concerning symptom scores we did combine AUA (7) and the symptom severity component of IPSS since they are identical. Studies using the Danish score were not included although interestingly methods to calculate equivalence of these varied measures of symptom severity have been put forward.[4] A systematic review such as ours only gives an assessment of comparative effectiveness based on the available primary data that is of sufficient quality. For endoscopic removal of benign prostatic tissue we can state in agreement with Sivanandam that TURP, because it is the established procedure and remains highly effective, should continue to be considered as the standard approach. On the other hand the meta-analysis shows that HoLEP is as effective and achieves the hoped for reduction in bleeding and hospital stay. There is a wide range of other treatments that might be more suitable to certain groups of patients and health systems and a paper is currently under review comparing minimally invasive treatments for BPE with TURP. The question as to whether added benefits from any alternative procedures to TURP are worthwhile will be addressed by our forthcoming economic evaluation and by further high-quality comparative studies. References 1 Sivanandam A, Bhandari M. Transurethral resection, the mother of minimally invasive surgery in urology: beyond the gold standard . BMJ.com (10 July 2008). Available at: URL: http://www.bmj.com/cgi/eletters/337/jun30_1/a449#198652 2 Lourenco T, Pickard R, Vale L, Grant AM, Fraser C, MacLennan GS et al. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: a systematic review of randomised controlled trials. Br Med J 2008;337:a449, doi: 10.1136/bmj.39575.517674.BE. 3 Ekengren J, Haendler L, Hahn RG. Clinical outcome 1 year after transurethral vaporization and resection of the prostate. Urology 2000;55:231-5. 4 Hansen BJ, Mortensen S, Mensink HJ, Flyger H, Rihmann M, Hendolin N, Nordling J, Hald T. Comparison of the Danish Prostatic Score with the international Prostatic Symptom Score, the Madsen-Iversen and Boyarsky symptom indexes. ALFECH Study Group. BR J Urol 1998;81(1);36-41 Competing interests: None declared |
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John B Davies, Staff Grade in Urology Urology Department, Freeman Hospital, Newcastle upon Tyne, NE7 7DN
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It is a pity that details of the variety of laser types and delivery techniques used in the papers quoted was not given, as the only laser technique subsequently mentioned is the potassium-titanyl-phosphate laser. I would be grateful for the authors checking the paragraph relating to Incontinence,(page 5)as the conclusion reached on the van Melick paper seems contrary to that reached by the original author. Competing interests: KTP laser user |
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Tania Lourenco, Research fellow University of Aberdeen, Health Services Research Unit, Robert Pickard, Luke Vale, Adrian Grant, Cynthia Fraser, Graeme MacLennan, James N’Dow and the Benign Prostatic Enlargement team
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We thank J. Davies for commenting our study.[1] With respect to the data on incontinence reported in the van Melick study our conclusion is correct as van Melick and colleagues[2] report (page 1031) that ‘the incidence of incontinence was 8%, 39%, and 15% in the TURP, laser, and electrovaporization groups, respectively’.[2] In respect to the types of lasers and the delivery mode used by the individual studies, these were considered, however, in the enterest of brevity, these details were not reported in our article. An HTA report will shortly become available, where we provide full descriptions of the interventions evaluated. 1. Lourenco T, Pickard R, Vale L, Grant AM, Fraser C, MacLennan GS et al. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: a systematic review of randomised controlled trials. Br Med J 2008;337:a449, doi: 10.1136/bmj.39575.517674.BE. 2. van Melick HH, van Venrooij GE, Boon TA. Long-term follow-up after transurethral resection of the prostate, contact laser prostatectomy, and electrovaporization. Urology 2003;62:1029-34. Competing interests: None declared |
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