Evert L. Koldewijn

Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe.

BACKGROUND Silodosin is a new selective therapy with a high pharmacologic selectivity for the α(1A)-adrenoreceptor. OBJECTIVE Our aim was to test silodosins superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin. DESIGN, SETTING, AND PARTICIPANTS We conducted a multicenter double-blind, placebo- and active-controlled parallel group study. A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score (IPSS) ≥13 and a urine maximum flow rate (Q(max)) >4 and ≤15 ml/s were selected at 72 sites in 11 European countries. The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period. A total of 955 patients were randomized (2:2:1) to silodosin 8 mg (n=381), tamsulosin 0.4 mg (n=384), or placebo (n=190) once daily for 12 wk. MEASUREMENTS We calculated the change from baseline in IPSS total score (primary), storage and voiding subscores, quality of life (QoL) due to urinary symptoms, and Q(max). Responders were defined on the basis of IPSS and Q(max) by a decrease of ≥25% and an increase of ≥30% from baseline, respectively. RESULTS AND LIMITATIONS The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo (p<0.001): difference active placebo of -2.3 (95% confidence interval [CI], -3.2, -1.4) with silodosin and -2.0 (95% CI,-2.9, -1.1) with tamsulosin. Responder rates according to total IPSS were significantly higher (p<0.001) with silodosin (66.8%) and tamsulosin (65.4%) than with placebo (50.8%). Active treatments were also superior to placebo in the IPSS storage and voiding subscore analyses, as well as in QoL due to urinary symptoms. Of note, only silodosin significantly reduced nocturia versus placebo (the change from baseline was -0.9, -0.8, and -0.7 for silodosin, tamsulosin, and placebo, respectively; p=0.013 for silodosin vs placebo). An increase in Q(max) was observed in all groups. The adjusted mean change from baseline to end point was 3.77 ml/s for silodosin, 3.53 ml/s for tamsulosin, and 2.93 ml/s for placebo, but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response (silodosin vs placebo: p=0.089; tamsulosin vs placebo: p=0.221). At end point, the percentage of responders by Q(max) was 46.6%, 46.5%, and 40.5% in the silodosin, tamsulosin, and placebo treatment groups, respectively. This difference was not statistically significantly (p=0.155 silodosin vs placebo and p=0.141 tamsulosin vs placebo). Active treatments were well tolerated, and discontinuation rates due to adverse events were low in all groups (2.1%, 1.0%, and 1.6% with silodosin, tamsulosin, and placebo, respectively). The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm (14%), a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug. The incidence was higher than that observed with tamsulosin (2%); however, only 1.3% of silodosin-treated patients discontinued treatment due to this adverse event. CONCLUSIONS Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia. Its overall efficacy is not inferior to tamsulosin. Only silodosin showed a significant effect on nocturia over placebo. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT00359905.

Results of the European Basic Laparoscopic Urological Skills Examination

BACKGROUND In 2011, the European Basic Laparoscopic Urological Skills (E-BLUS) examination was introduced as a pilot for the examination of final-year urologic residents. OBJECTIVE In this study, we aimed to answer the following research questions: What level of laparoscopic skills do final-year residents in urology have in Europe, and do the participants of the E-BLUS pass the examination according to the validated criteria? DESIGN, SETTING, AND PARTICIPANTS Participants of the examination were final-year urology residents from different European countries taking part in the European Urology Residents Education Program in 2011 and 2012. SURGICAL PROCEDURE The E-BLUS exam consists of five tasks validated for the training of basic urologic laparoscopic skills. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Performances of the tasks were recorded on DVD and analysed by an objective rater. Time and number of errors made in tasks 1-4 were noted. Furthermore, all expert laparoscopic urologists were asked to score participants on a global rating scale (1-5) based on three items: depth perception, bimanual dexterity, and efficiency. Participants were asked to complete a questionnaire on prior training and laparoscopic experience. RESULTS AND LIMITATIONS Seventy DVD recordings were analysed. Most participants did not pass the time criteria on task 4 (90%), task 2 (85.7%), task 1 (74.3%), and task 5 (71.4%). Task 3 was passed by 84.3%. The overall quality score was passed by 64%. When combining time and quality, only three participants (4.2%) passed the examination according to the validated criteria. According to the questionnaire, 61% did not have the opportunity to train in laparoscopic skills. CONCLUSIONS The results of the E-BLUS examination show that the level of basic laparoscopic skills among European residents is low. Although quality of performance is good, most residents do not pass the validated time criteria. Regular laparoscopic training or a dedicated fellowship should improve the laparoscopic level of residents in urology.

The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation

OBJECTIVE To investigate the value of the physical Simbla Transurethral Resection of a Bladder Tumor (TURBT) simulator as an educational tool within urological residency training, by means of a training needs analysis (TNA) and assessment of its feasibility, acceptability, and face, content, and construct validity. METHODS To analyze the training needs for TURBT, procedural steps and pitfalls were identified and the TNA was completed during an expert consensus meeting. Participants (n = 76) were divided into three groups based on their experience in TURBT: novices, intermediates, and experts. Participants performed two standardized TURBT procedures on the simulator. Face validity and content validity, as well as feasibility and acceptability, were assessed with a quantitative survey. Construct validity was assessed by comparing the performance of novices, intermediates, and experts on resection time, quality of tumor resection, and overall performance. RESULTS Of the 21 procedural steps and 17 pitfalls defined in TNA, 13 steps and 8 pitfalls were covered by the Simbla. Participants rated the Simblas overall realism (face validity) with a score of 8 of 10 (range 6-9). The simulator was judged to be most useful (content validity) for learning eye-hand coordination: score 8 (6-10). All aspects regarding realism and usefulness were rated above the acceptability threshold of 6/10. Intermediates (100%) and experts (96%) considered the Simbla to be a useful educational tool within the urological curriculum. Resection time was longer for novices than for experts (p < 0.05; construct validity). In addition, the overall performance of novices was rated lower compared with intermediates and experts, and novices showed more irradical resections and bladder perforations (all p < 0.05). CONCLUSIONS The Simbla TURBT simulator is a valid, feasible, and acceptable educational tool for training procedural skills and may be implemented in the urological curriculum to complement learning in clinical practice. TNA is valuable in defining training objectives and evaluating the educational value of a simulator.

Patient Safety Risks of Basic Urological Procedures Performed by Junior and Senior Residents.

OBJECTIVE To investigate the current performance of urological residents regarding basic urological procedures in relation to patient safety issues and the identification of specific training needs. DESIGN Observational data of 146 urethrocystoscopies (UCSs), 27 transrectal ultrasounds of the prostate (TRUSs), 38 transrectal ultrasound-guided prostatic biopsies (TRUSPs), and 30 transurethral resections of bladder tumor (TURBTs) were collected. Performance was evaluated using scoring lists including details on completeness of procedural steps, level of independence, time, and the incidence of unintended events. The causal factors contributing to the unintended events were identified by 2 expert urologists and classified according to the recognized PRISMA method. SETTING This study was performed in 5 teaching hospitals in the Netherlands. PARTICIPANTS We included 11 junior residents and 5 senior residents in urology in the final study cohort. RESULTS Senior residents showed a lower degree of completeness in material usage than junior residents did during UCS (p < 0.01) and in preparation, material usage, and procedure during TRUSP (all p < 0.05). In UCS and TURBT, senior residents received significantly less feedback than junior residents did (both p < 0.01). Incidence of unintended events for junior vs senior residents was 11% and 4% in UCS, 0% and 7% in transrectal ultrasound of the prostate, 36% and 62% in TRUSP, and 41% and 23% in TURBT, respectively. Overall, unintended events were mainly caused by human factors, in particular, verification and skills-based issues. CONCLUSION Present performance of basic urological procedures involves a high percentage of unintended events, especially in TRUSP and TURBT, which are mainly caused by human factors and are a potential threat for patient safety. Junior residents are less independent but more thorough in the performance of UCS and TRUSP than senior residents are. Targeted skills training including assessment should be implemented before privileges for independent practice are granted to reduce the incidence of unintended events and optimize patient safety.

Training robotic surgery in urology: experience and opinions of robot urologists

To answer the research questions: (a) what were the training pathways followed by the first generation of robot urologists; and (b) what are their opinions on the ideal training for the future generation?

Evaluation of the Educational Value of a Virtual Reality TURP Simulator According to a Curriculum-based Approach

Purpose This study aimed to evaluate the place of the TURPsim (Simbionix/VirtaMed, Beit Goal, Israel) within a urologic residency training curriculum, including training needs analysis (TNA) and investigating its validity. Materials and Methods Training needs analysis was conducted by an expert panel to identify procedural steps and pitfalls. Performance metrics of the simulator were compared with the TNA results. Participants were distributed according to their level of experience (completed transurethral resection of the prostate [TURP] procedures) as follows: novices (0), intermediates (1–50), and experts (>50). They followed standardized instructions and then performed 2 complete TURP procedures on the TURPsim. Results Ten of 22 procedural steps (TNA) and 4 of 11 pitfalls were covered by the TURPsim. A total of 66 participants, 22 in each group, were included. Median general judgment (face and content) about the TURPsim was rated 7.3 (median, 7; range, 3–9). Ninety-three percent of all participants qualified the TURPsim as a useful training model. Intermediates and experts had a significant faster resection time and less blood loss compared with novices (construct) (P = 0.001). Novices needed to re-resect previous lobes, and they also resected the prostate in the incorrect order more frequently compared with intermediates and experts. Conclusions Training needs analysis is of paramount importance in the evaluation process of a training program. This curriculum-based approach including validity of a simulator seems valuable and may narrow the gap between skills laboratory and clinical practice. This study showed face, content, and construct validity of the TURPsim, and this simulator finds its place in the current urologic curriculum to train basic and procedural TURP skills.

Development and validation of the TOCO–TURBT tool: a summative assessment tool that measures surgical competency in transurethral resection of bladder tumour

BackgroundThe current shift towards competency-based residency training has increased the need for objective assessment of skills. In this study, we developed and validated an assessment tool that measures technical and non-technical competency in transurethral resection of bladder tumour (TURBT).MethodsThe ‘Test Objective Competency’ (TOCO)–TURBT tool was designed by means of cognitive task analysis (CTA), which included expert consensus. The tool consists of 51 items, divided into 3 phases: preparatory (n = 15), procedural (n = 21), and completion (n = 15). For validation of the TOCO–TURBT tool, 2 TURBT procedures were performed and videotaped by 25 urologists and 51 residents in a simulated setting. The participants’ degree of competence was assessed by a panel of eight independent expert urologists using the TOCO–TURBT tool. Each procedure was assessed by two raters. Feasibility, acceptability and content validity were evaluated by means of a quantitative cross-sectional survey. Regression analyses were performed to assess the strength of the relation between experience and test scores (construct validity). Reliability was analysed by generalizability theory.ResultsThe majority of assessors and urologists indicated the TOCO–TURBT tool to be a valid assessment of competency and would support the implementation of the TOCO–TURBT assessment as a certification method for residents. Construct validity was clearly established for all outcome measures of the procedural phase (all r > 0.5, p < 0.01). Generalizability-theory analysis showed high reliability (coefficient Phi ≥ 0.8) when using the format of two assessors and two cases.ConclusionsThis study provides first evidence that the TOCO–TURBT tool is a feasible, valid and reliable assessment tool for measuring competency in TURBT. The tool has the potential to be used for future certification of competencies for residents and urologists. The methodology of CTA might be valuable in the development of assessment tools in other areas of clinical practice.

High level of patient satisfaction and comfort during diagnostic urological procedures performed by urologists and residents.

Abstract Objective. The aim of this study was to investigate how patients experience diagnostic urological procedures performed by urologists, junior residents and senior residents, and to assess the influence of procedure-related factors on patient experiences. Methods. Data were collected during 222 procedures: 84 transrectal ultrasound-guided prostate biopsies (TRUSP; urologists n = 39, residents n = 45) and 138 urethrocystoscopies (UCS; urologists n = 44, residents n = 94) in six hospitals. Patient experiences were assessed using a questionnaire focusing on pain, comfort and satisfaction (visual analogue scale, 0–10) and communication aspects on a four-point Likert scale. Clinical observations were made to identify influencing factors. Results. Median values for patient experiences across procedures were 10 (range 5–10) for patient satisfaction, 2 (0–9) for pain and 8 (0–10) for comfort. Generalized estimating equations revealed no significant differences between urologists, senior residents and junior residents in terms of experienced patient comfort, satisfaction or pain. Procedural time was longer for residents, but this did not correlate significantly with patient-experienced comfort (p = 0.3). In UCS, patient comfort and satisfaction were higher in the supine position for male and female patients, respectively (p < 0.01). In TRUSP, local anaesthesia resulted in a significant decrease in pain (p = 0.002) and an increase in comfort (p = 0.03). Finally, older patients experienced less pain and gave higher comfort and satisfaction responses than younger patients. Conclusions. Patients expressed high levels of satisfaction and comfort during diagnostic urological procedures. Experiences were not affected by the level of training, suggesting highly developed interpersonal and communication skills for residents in an early stage of residency training. Patients demonstrated significant preferences for local anaesthesia in TRUSP and performance of UCS in the supine position over the lithotomy position.