Charalampos Mamoulakis

EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction

CONTEXT Lower urinary tract symptoms (LUTS) represent one of the most common clinical complaints in adult men and have multifactorial aetiology. OBJECTIVE To develop European Association of Urology (EAU) guidelines on the assessment of men with non-neurogenic LUTS. EVIDENCE ACQUISITION A structured literature search on the assessment of non-neurogenic male LUTS was conducted. Articles with the highest available level of evidence were selected. The Delphi technique consensus approach was used to develop the recommendations. EVIDENCE SYNTHESIS As a routine part of the initial assessment of male LUTS, a medical history must be taken, a validated symptom score questionnaire with quality-of-life question(s) should be completed, a physical examination including digital rectal examination should be performed, urinalysis must be ordered, post-void residual urine (PVR) should be measured, and uroflowmetry may be performed. Micturition frequency-volume charts or bladder diaries should be used to assess male LUTS with a prominent storage component or nocturia. Prostate-specific antigen (PSA) should be measured only if a diagnosis of prostate cancer will change the management or if PSA can assist in decision-making for patients at risk of symptom progression and complications. Renal function must be assessed if renal impairment is suspected from the history and clinical examination, if the patient has hydronephrosis, or when considering surgical treatment for male LUTS. Uroflowmetry should be performed before any treatment. Imaging of the upper urinary tract in men with LUTS should be performed in patients with large PVR, haematuria, or a history of urolithiasis. Imaging of the prostate should be performed if this assists in choosing the appropriate drug and when considering surgical treatment. Urethrocystoscopy should only be performed in men with LUTS to exclude suspected bladder or urethral pathology and/or before minimally invasive/surgical therapies if the findings may change treatment. Pressure-flow studies should be performed only in individual patients for specific indications before surgery or when evaluation of the pathophysiology underlying LUTS is warranted. CONCLUSIONS These guidelines provide evidence-based practical guidance for assessment of non-neurogenic male LUTS. An extended version is available online (www.uroweb.org/guidelines). PATIENT SUMMARY This article presents a short version of European Association of Urology guidelines for non-neurogenic male lower urinary tract symptoms (LUTS). The recommended tests should be able to distinguish between uncomplicated male LUTS and possible differential diagnoses and to evaluate baseline parameters for treatment. The guidelines also define the clinical profile of patients to provide the best evidence-based care. An algorithm was developed to guide physicians in using appropriate diagnostic tests.

Bipolar versus Monopolar Transurethral Resection of the Prostate: A Systematic Review and Meta-analysis of Randomized Controlled Trials

CONTEXT Incorporation of bipolar technology in transurethral resection (TUR) of the prostate (TURP) potentially offers advantages over monopolar TURP (M-TURP). OBJECTIVE To evaluate the evidence by a meta-analysis, based on randomized controlled trials (RCTs) comparing bipolar TURP (B-TURP) with M-TURP for benign prostatic obstruction. Primary end points included efficacy (maximum flow rate [Q(max)], International Prostate Symptom Score) and safety (adverse events). Secondary end points included operation time and duration of irrigation, catheterization, and hospitalization. EVIDENCE ACQUISITION Based on a detailed, unrestricted strategy, the literature was searched up to February 19, 2009, using Medline, Embase, Science Citation Index, and the Cochrane Library to detect all relevant RCTs. Methodological quality assessment of the trials was based on the Dutch Cochrane Collaboration checklist. Meta-analysis was performed using Review Manager 5.0. EVIDENCE SYNTHESIS Sixteen RCTs (1406 patients) were included. Overall trial quality was low (eg, allocation concealment and blinding of outcome assessors were poorly reported). No clinically relevant differences in short-term (12-mo) efficacy were detected (Q(max): weighted mean difference [WMD]: 0.72 ml/s; 95% confidence interval [CI], 0.08-1.35; p=0.03). Data on follow-up of >12 mo are scarce for B-TURP, precluding long-term efficacy evaluation. Treating 50 patients (95% CI, 33-111) and 20 patients (95% CI, 10-100) with B-TURP results in one fewer case of TUR syndrome (risk difference [RD]: 2.0%; 95% CI, 0.9-3.0%; p=0.01) and one fewer case of clot retention (RD: 5.0%; 95% CI, 1.0-10%; p=0.03), respectively. Operation times, transfusion rates, retention rates after catheter removal, and urethral complications did not differ significantly. Irrigation and catheterization duration was significantly longer with M-TURP (WMD: 8.75 h; 95% CI, 6.8-10.7 and WMD: 21.77 h; 95% CI, 19.22-24.32; p<0.00001, respectively). Inferences for hospitalization duration could not be made. PlasmaKinetic TURP showed an improved safety profile. Data on TUR in saline (TURis) are not yet mature to permit safe conclusions. CONCLUSIONS No clinically relevant differences in short-term efficacy exist between the two techniques, but B-TURP is preferable due to a more favorable safety profile (lower TUR syndrome and clot retention rates) and shorter irrigation and catheterization duration. Well-designed multicentric/international RCTs with long-term follow-up and cost analysis are still needed.

The modified Clavien classification system: a standardized platform for reporting complications in transurethral resection of the prostate

PurposeThe aim of the study was to evaluate the applicability of the modified Clavien classification system (CCS) in grading perioperative complications of transurethral resection of the prostate (TURP).MethodsAll patients with benign prostatic hyperplasia submitted to monopolar TURP from January 2006 to February 2008 at a non-academic center were evaluated for complications occurring up to the end of the first postoperative month. All complications were classified according to the modified CCS independently by two urologists, and the final decision was based on consensus. If multiple complications per patient occurred, categorization was done in more than one grade. Results were presented as complication rates per grade.ResultsForty-four complications were recorded in 31 out of 198 patients (overall perioperative morbidity rate: 15.7%), and their grading was generally easy, non-time-consuming and straightforward. Most of them were classified as grade I (59.1%) and II (29.5%). Higher grade complications were scarce (grade III: 2.3% and grade IV: 6.8%, respectively) There was one death (grade V: 2.3%) due to acute myocardial infarction (overall mortality rate: 0.5%). Negative outcomes such as mild dysuria during this early postoperative period or retrograde ejaculation were considered sequelae and were not recorded. Nobody was complicated with severe dysuria. There was one re-operation due to residual adenoma (0.5%).ConclusionsThe modified CCS represents a straightforward and easily applicable tool that may help urologists to classify the complications of TURP in a more objective and detailed way. It may serve as a standardized platform of communication among clinicians allowing for sound comparisons.

Perioperative Morbidity of Laparoscopic Cryoablation of Small Renal Masses with Ultrathin Probes: A European Multicentre Experience

BACKGROUND Low morbidity has been advocated for cryoablation of small renal masses. OBJECTIVES To assess negative perioperative outcomes of laparoscopic renal cryoablation (LRC) with ultrathin cryoprobes and patient, tumour, and operative risk factors for their development. DESIGN, SETTING, AND PARTICIPANTS Prospective collection of data on LRC in five centres. INTERVENTION LRC. MEASUREMENTS Preoperative morbidity was assessed clinically and the American Society of Anaesthesiologists (ASA) score was assigned prospectively. Charlson Comorbidity Index (CCI) and Charlson-Age Comorbidity Index (CACI) scores were retrospectively assigned. Negative outcomes were prospectively recorded and defined as any undesired event during the perioperative period, including complications, with the latter classed according to the Clavien system. Patient, tumour, and operative variables were tested in univariate analysis as risk factors for occurrence of negative outcomes. Significant variables (p<0.05) were entered in a step-forward multivariate logistic regression model to identify independent risk factors for one or more perioperative negative outcomes. The confidence interval was settled at 95%. RESULTS AND LIMITATIONS There were 148 procedures in 144 patients. Median age and tumour size were 70.5 yr (range: 32-87) and 2.6 cm (range: 1.0-5.6), respectively. A laparoscopic approach was used in 145 cases (98%). Median ASA, CCI, and CACI scores were 2 (range: 1-3), 2 (range: 0-7), and 4 (range: 0-11), respectively. Comorbidities were present in 79% of patients. Thirty negative outcomes and 28 complications occurred in 25 (17%) and 23 (15.5%) cases, respectively. Only 20% of all complications were Clavien grade > or = 3. Multivariate analysis showed that tumour size in centimetres, the presence of cardiac conditions, and female gender were independent predictors of negative perioperative outcomes occurrence. Receiver operator characteristic curve confirmed the tumour size cut-off of 3.4 cm as an adequate predictor of negative outcomes. CONCLUSIONS Perioperative negative outcomes and complications occur in 17% and 15.5%, respectively, of cases treated by LRC with multiple ultrathin needles. Most of the complications are Clavien grade 1 or 2. The presence of cardiac conditions, female gender, and tumour size are independent prognostic factors for the occurrence of a perioperative negative outcome.

Bipolar transurethral resection of the prostate: the 'golden standard' reclaims its leading position

Purpose of review To summarize recent knowledge from experimental studies and randomized clinical trials in benign prostate hyperplasia that compare bipolar with monopolar transurethral resection, with an emphasis on morbidity. Recent findings Bipolar transurethral resection of the prostate has a urodynamicaly proven efficacy to relieve bladder outlet obstruction, which seems to be durable in time with low long-term complication rates. The haemostatic capacity of bipolar current is shown to be superior in ex-vivo studies. Postoperative bleeding and blood transfusion rates are similar. Clot retention and transurethral resection syndrome rates are significantly lower in patients treated with bipolar resection. Catheterization time and length of hospital stay are statistically shorter for Gyrus but insignificant for the transurethral resection in a saline system compared with monopolar resection. Urethral stricture rates do not differ significantly between arms. Summary Bipolar shares similar clinical efficacy with monopolar transurethral resection of the prostate, durable in time with low long-term complication rates. It has minimized bleeding risk and eliminated transurethral resection syndrome. The evidence derived from randomized clinical trials does not support a statistically significant incidence of urethral strictures with bipolar compared with monopolar current.

Results from an international multicentre double-blind randomized controlled trial on the perioperative efficacy and safety of bipolar vs monopolar transurethral resection of the prostate: COMPARISON OF B-TURP VS M-TURP IN A MULTICENTRE RCT SETTING

Study Type – Therapy (RCT)

Results from an international multicentre double‐blind randomized controlled trial on the perioperative efficacy and safety of bipolar vs monopolar transurethral resection of the prostate

Sir, Voiding symptoms due to BPH are common, with endoscopic transurethral resection (TUR) of the obstructing tissue still considered the ‘ gold standard ’ with 20 000 procedures undertaken in the UK in 2007, at an average annual cost of ≈ £ 70 million [ 1 ] . The authors are correct that traditional monopolar TUR of the prostate (mTURP) does have historical disadvantages for blood loss and risk of electrolyte disturbance, and as such, alternative technologies have been developed to match the symptom improvement, whilst reducing morbidity and hospital stay. This well designed randomised controlled trial highlights data in accordance with the contemporary clinical impression that the rates of TUR syndrome (0.7%) and blood loss requiring transfusion (2.9%) for mTURP are low; and that the total complication rate is comparable with the newer bipolar TURP (bTURP) technology (31 vs 27%) [ 2 ] . Although the authors have compared catheterisation times between mTURP and bTURP (3.0 vs 3.1 days), the data is conspicuously lacking in not addressing the important question of hospital stay between the groups. This parameter is widely used as the economic driver for the introduction of laser or bipolar technology as a day case procedure. Health services across the globe are facing unprecedented reforms. With budget static in real terms, the UK ’ s NHS needs to fi nd effi ciencies worth £ 15 – 20 billon over the next 4 years to keep pace with rising demand. Increasing the relative amount of day-case and short-stay elective surgery is an obvious source of savings. However, the evidence for an economic benefi t with bTURP is limited, and often dependent on comparative mTURP hospital stays of > 2 days [ 1,3 – 5 ] . We would argue that a 23-h stay should be the preoperative intention in all patients undergoing mTURP, and routine in-patient stays in excess of this should be consigned to history. We audited 125 mTURP cases at our institution over 12 months, with the intention preoperatively of undertaking them as a short-stay procedure. The median hospital stay was < 23 h in all-comers. The mean weight of tissue resected was 23.4 g. The median time to trial without catheter (TWOC) was 4 days; with a successful TWOC rate of 94%. We have achieved this through a combination of improved patient and staff education and hence expectation; meticulous haemostasis; and the addition of postoperative diuresis with one dose of i.v. furosemide or mannitol. The patient is managed in a streamlined 23-h short-stay unit with bladder irrigation discontinued in recovery, and early mobilisation encouraged. This has maximised throughput of patients without compromising outcomes.

Two contemporary series of percutaneous tract dilation for percutaneous nephrolithotomy.

Dilation of the tract for percutaneous nephrolithotomy can be performed with three different basic techniques. A retrospective outcome analysis of two techniques-metal telescoping dilation and balloon dilation-in a contemporary series of two European departments shows no significant difference in morbidity related to the dilation procedure. A literature survey that concentrates on publications with a focus on tract dilation shows that balloon dilation is the most frequently performed, but the morbidity reported for the different techniques appears identical. The three standard techniques have been developed more than 20 years ago. Very few new techniques have been added.

Midterm Results from an International Multicentre Randomised Controlled Trial Comparing Bipolar with Monopolar Transurethral Resection of the Prostate

BACKGROUND Pooled data from randomised controlled trials (RCTs) with short-term follow-up have shown a safety advantage for bipolar transurethral resection of the prostate (B-TURP) compared with monopolar TURP (M-TURP). However, RCTs with follow-up >12 mo are scarce. OBJECTIVE To compare the midterm safety/efficacy of B-TURP versus M-TURP. DESIGN, SETTING, AND PARTICIPANTS From July 2006 to June 2009, TURP candidates with benign prostatic obstruction were consecutively recruited in four centres, randomised 1:1 into the M-TURP or the B-TURP arm and regularly followed up to 36 mo postoperatively. A total of 295 patients were enrolled. INTERVENTION M-TURP or B-TURP using the AUTOCON II 400 electrosurgical unit. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Safety was estimated by complication rates with a special emphasis on urethral strictures (US) and bladder neck contractures (BNCs) recorded during the short-term (up to 12 mo) and midterm (up to 36 mo) follow-up. Efficacy quantified by changes in maximum urine flow rate, postvoid residual urine volume, and International Prostate Symptom Score was compared with baseline, and reintervention rates in each arm were also evaluated. RESULTS AND LIMITATIONS A total of 279 patients received treatment after allocation. Mean follow-up was 28.8 mo. A total of 186 of 279 patients (66.7%) completed the 36-mo follow-up. Posttreatment withdrawal rates did not differ significantly between arms. Safety was assessed in 230 patients (82.4%) at a mean follow-up of 33.4 mo. Ten US cases were seen in each arm (M-TURP vs B-TURP: 9.3% vs 8.2%; p=0.959); two versus eight BNC cases (M-TURP vs B-TURP: 1.9% vs 6.6%; p=0.108) were collectively detected at the midterm follow-up. Resection type was not a significant predictor of the risk of US/BNC formation. Efficacy was similar between arms and durable. A total of 10 of 230 patients (4.3%) experienced failure to cure and needed reintervention without significant differences between arms. High overall reintervention rates, withdrawal rates, and sample size determination not based on US/BNC rates represent potential limitations. CONCLUSIONS The midterm safety and efficacy of B-TURP and M-TURP are comparable. TRIAL REGISTRATION Netherlands Trial Register, NTR703 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=703).

Systematic review and meta-analysis of the clinical effectiveness of bipolar compared with monopolar transurethral resection of the prostate (TURP)

To compare monopolar and bipolar transurethral resection of the prostate (TURP) for clinical effectiveness and adverse events. We conducted an electronic search of MEDLINE, Embase, CENTRAL, Science Citation Index, and also searched reference lists of articles and abstracts from conference proceedings for randomised controlled trials (RCTs) comparing monopolar and bipolar TURP. Two reviewers independently undertook data extraction and assessed the risk of bias in the included trials using the tool recommended by the Cochrane Collaboration. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. From the 949 abstracts that were identified, 94 full texts were assessed for eligibility and a total of 24 trials were included in the review. No statistically significant differences were found in terms of International Prostate Symptom Score (IPSS) or health‐related quality of life (HRQL) score. Results for maximum urinary flow rate were significant at 3, 6 and 12 months (all P < 0.001), but no clinically significant differences were found and the meta‐analysis showed evidence of heterogeneity Bipolar TURP was associated with fewer adverse events including transurethral resection syndrome (risk ratio [RR] 0.12, 95% confidence interval [CI] 0.05–0.31, P < 0.001), clot retention (RR 0.48, 95% CI 0.30–0.77, P = 0.002) and blood transfusion (RR 0.53, 95% CI 0.35–0.82, P = 0.004) Several major methodological limitations were identified in the included trials; 22/24 trials had a short follow‐up of ≤1 year, there was no evidence of a sample size calculation in 20/24 trials and the application of GRADE showed the evidence for most of the assessed outcomes to be of moderate quality, including all those in which statistical differences were found. Whilst there is no overall difference between monopolar and bipolar TURP for clinical effectiveness, bipolar TURP is associated with fewer adverse events and therefore has a superior safety profile. Various methodological limitations were highlighted in the included trials and as such the results of this review should be interpreted with caution. There is a need for further well‐conducted, multicentre RCTs with long‐term follow‐up data.