Analysis of pitfalls encountered by residents in transurethral procedures in master-apprentice type of training.

BACKGROUND AND PURPOSE: Today's simulators are frequently limited in their possibilities to train all aspects of endourological procedures. It is therefore indicated to first make an inventory of training needs before (re)developing simulators. This study examined pitfalls encountered by residents in real-time transurethral procedures. MATERIALS AND METHODS: First, difficulties that residents encounter in transurethral procedures (transurethral resection of the bladder tumor [TURBT], transurethral resection of the prostate [TURP], ureterorenoscopy [URS]) were identified by asking urologists and residents to complete an open questionnaire. Based on their answers a list of pitfalls was designed and tested in 28 pilot observations. Then, two raters (interrater agreement 0.72, 0.70, and 0.75 for TURBT, TURP, and URS, respectively) categorized all observed procedure-related interactions between residents and supervisors in 80 procedures as (1) (type of ) pitfall or (2) no pitfall. RESULTS: Pitfalls most frequently encountered were as follows: (1) planning/anticipation on new situations (median 27.3%, 29.3%, and 31.8% of total pitfalls in TURBT, TURP, and URS, respectively); (2) handling of instruments (11.5%, 10.6%, and 20.0% for TURBT, TURP, and URS); (3) irrigation management for TURBT (7.7%), depth of resection for TURP (8.9%), and use of X-ray for URS (13.3%). CONCLUSION: Designers of endourological simulators should include possibilities to train planning/anticipation on new situations, handling of instruments in all transurethral procedures, and irrigation management in TURBT, depth of resection in TURP, and timing usage of X-ray in URS.

Acquisition of flexible cystoscopy skills on a virtual reality simulator by experts and novices.

OBJECTIVE: To assess the construct validity of the URO Mentor (Simbionix Corp., Cleveland, OH, USA) virtual reality training model for several variables of skills training in cysto-urethroscopy, addressing two research questions: (i) Does training on the URO Mentor significantly improve novices' performance in terms of time, trauma, areas inspected and Global Rating Scale (GRS) score?; (ii) is discrimination between different levels of expertise possible using the URO Mentor? METHODS: Thirty experts and 50 novices performed seven tasks on the URO Mentor during one training session. The first, fourth and seventh tasks were 'test tasks' to evaluate participants' performance. The simulator recorded procedure time and trauma; a supervisor scored which areas were inspected and gave scores on the GRS. A two-way analysis of variance with repeated-measures test was used to analyse experts' and novices' performances, with P < 0.05 considered to indicate statistical significance. Effect sizes (ES) were calculated to quantify the practical significance of the results; ES of 0.10, 0.30, and 0.50 were considered small, medium and large, respectively. RESULTS: Novices' performances showed a significant improvement with large ES in time (linear trend of learning curve P < 0.001, ES 0.66) and mean GRS score (linear trend P < 0.001, ES 0.84, quadratic trend P = 0.018, ES 0.24). There was a medium improvement for trauma (linear trend P < 0.001, ES 0.40) and a small improvement in areas inspected (linear trend P = 0.032, ES 0.21). That the 95% confidence intervals of the measures on the first task of experts and novices did not coincide indicates that differentiation between experts and novices on the four variables measured can be achieved using the URO Mentor. CONCLUSIONS: Training on the URO Mentor appears to result in a medium to large improvement of novices' performances for time, trauma, areas inspected and GRS scores. Moreover, discrimination between different levels of expertise is possible using this simulator.

Transfer of cysto-urethroscopy skills from a virtual-reality simulator to the operating room: a randomized controlled trial.

OBJECTIVE: To assess whether real-time cysto-urethroscopy (CUS) performance improves by simulator-based training (criterion or predictive validity), addressing the research question 'Does practical skills training on the URO Mentor (UM, Simbionix USA Corp., Cleveland, OH, USA) virtual-reality simulator improve the performance of flexible CUS in patients'. SUBJECTS AND METHODS: Participants (71 interns from Catharina Hospital Eindhoven, CHE, and 29 from University Medical Centre Groningen, UMCG) were randomized to carry out CUS in a patient after training on the UM (UM-trained, 50) or without training on UM (control, 50). The assessment of real-time performance consisted of scoring on a Global Rating Scale (GRS) by supervisors unaware of training status. Data were analysed using stepwise multiple linear regression. The effect size (ES) indication for correlations was used to interpret the magnitude of a standard regression coefficient (beta); an ES of 0.10, 0.30 and 0.50 were considered small, moderate and large, respectively. The study was approved by the Medical Review Ethics Committees of the participating hospitals. RESULTS: Overall, the group that received training performed significantly better than the controls (P < or = 0.003, beta range 0.30-0.47). There was no effect of training for participants with a specific preference for a surgical speciality in two of five GRS scores. Participants from CHE obtained higher GRS 3 scores than those from UMCG. Significantly more UMCG trainees indicated having had stress than those from CHE (P < 0.001). CONCLUSIONS: The results showed that interns who had trained on UM outperformed controls for a CUS procedure in a patient. Training for CUS on the UM is to be recommended for learning to respect tissue, procedural knowledge, flow of procedure and forward planning. Use of the UM to train interns with a specific interest in a surgical speciality in handling instruments, and time and motion, seems to be of limited value.

The virtual reality endourologic simulator is realistic and useful for educational purposes.

PURPOSE: To examine the educational value of URO Mentor, a virtual reality simulator for endourologic procedures, by establishing its face and content validity. MATERIALS AND METHODS: Eighty-nine urologists and residents in urology performed a urethrocystoscopy task (bladder inspection, biopsy, and coagulation) or a ureterorenoscopy task (manipulation of a distal ureter stone) using the URO Mentor. They completed an evaluation questionnaire about these tasks. Questionnaire bias related to task performance on URO Mentor was analyzed as well (Hawthorne effect). RESULTS: The overall rating of the URO Mentor was 7.3 on a 10-point scale (1 = poor, 10 = excellent). Regression analysis showed that ratings were not related to previous experience or task performance using the URO Mentor. Of all subjects, 25% rated the realism of URO Mentor as >or=3.5 on a five-point scale, and 82% rated its usefulness as an educational tool as >or=3.5 on a five-point scale. More than 73% of all participants said they would purchase a URO Mentor if financial means were available; participants who needed more time to complete the task were less positive in their answers to this question. CONCLUSIONS: URO Mentor appears to be a realistic and useful training model for endourologic procedures.

How useful and realistic is the uro trainer for training transurethral prostate and bladder tumor resection procedures?

PURPOSE: We evaluated the face and content validity (novice and expert opinions of realism and usefulness) of the Uro Trainer (Karl Storz GmbH, Tuttlingen, Germany), a simulator for transurethral resection procedures, to ascertain whether it is justifiable to continue the validation process by performing prospective experimental studies. MATERIALS AND METHODS: Between 2006 and 2008, 104 urologists and urology residents performed a transurethral bladder tumor resection and/or transurethral prostate resection procedure on the Uro Trainer, and rated simulator usefulness and realism on a 10-point scale (1-not at all useful/realistic/poor, 10-very useful/realistic/excellent). Participants were classified as experts (more than 50 procedures performed) or novices (50 or fewer procedures performed). Because the literature offered no guidelines for interpreting our data, we used criteria from other studies to interpret the results. RESULTS: A total of 161 questionnaires were analyzed from 97 (21% experts, 79% novices) and 64 (30% experts, 70% novices) participants who performed transurethral prostate resection and transurethral bladder tumor resection procedures, respectively. Mean usefulness, realism and overall scores varied from 5.6 to 8.2 (SD 1.4-2.5). Measured by validity criteria from other studies, Uro Trainer face and content validity was unsatisfactory, with ratings on only 3%, 5% and 8% of the parameters interpreted as positive, moderately acceptable and good, respectively. CONCLUSIONS: Measured against criteria from other validation studies, Uro Trainer face and content validity appears to be unsatisfactory. Modification of the simulator seems advisable before further experimental validation studies are initiated. The lack of general guidelines for establishing face and content validity suggests a need for consensus about appropriate methods for evaluating the validity of simulators.

Update on training models in endourology: a qualitative systematic review of the literature between January 1980 and April 2008.

CONTEXT: Interest in the use of simulators in urological skills training is on the increase. To ensure effective implementation of training models, an overview of the nature and validity of the available models is of the essence. OBJECTIVE: To obtain an overview of training models and their validity by performing a qualitative systematic review of the literature. EVIDENCE ACQUISITION: Studies were identified through searches of PubMed, the Cochrane Library, and Web of Science between January 1980 and April 2008 using two search strategies: "urology and (training or simulat or model)" and combinations of these terms with "prostate," "kidney," "bladder," or "ureter." Studies were included if they (1) described one or more training models, and/or (2) examined the validity of training models. Studies in undergraduate education and of training models for physical examination were excluded. Validation studies were scored according to Kirkpatrick and Oxford Centre for Evidence-Based Medicine (OCEBM) levels of evidence. EVIDENCE SYNTHESIS: Forty-five articles (out of the initial list of 4753 retrieved articles, 0.9%) were included, describing 30 types of training models and 54 validation studies. The largest number of models has been described for ureterorenoscopy (nine types). Only three randomised controlled trials (RCTs), receiving a 1b OCEBM level of evidence score, were found. Studies investigating the impact of simulator training on performance in patients (criterion B validity) were scarce. The number of participants in experimental studies ranged from 7 to 136. CONCLUSIONS: Due to growing interest in training models in urology, it is increasingly urgent to determine which of these models are most valuable for postgraduate training. Because the validation studies published so far are few in number, have low evidence levels, and are composed of only a few RCTs, it is important that more randomised controlled validation studies including larger numbers of participants are performed.

Causes of frequency and nocturia after renal transplantation.

OBJECTIVE: To explore the role of bladder capacity, bladder pain, dysfunctional voiding, urgency, urinary tract infections (UTIs), and urinary output as potential causes of frequency and nocturia after renal transplantation. PATIENTS AND METHODS: Data were gathered from 52 adult renal transplant patients (35 men and 17 women, mean age 49 years), using a written questionnaire, medical records, frequency/volume charts, and urinary cultures. The mean time between transplantation and data collection was 5 months. Structural equation modelling (SEM) was used for the simultaneous assessment of direct and indirect relationships between explanatory variables and voiding frequency. RESULTS: Frequency and nocturia were found in 54% and 60% of the study population, respectively. Frequency was directly associated with a small bladder capacity, bladder pain, urgency, and a high daytime urine volume, and indirectly by UTIs (via urgency and bladder pain). Nocturia was associated with high nocturnal urine volume, small bladder capacity and dysfunctional voiding. A quarter of the patients had small bladders and another quarter had large bladders, the latter being associated with nocturnal polyuria. CONCLUSIONS: The presence of frequency, especially when accompanied by bladder pain, might aid the physician to identify patients with small bladders. The presence of nocturia can be the result of a high nocturnal urine volume, which increases the risk of bladder enlargement. Because both abnormal bladder conditions can contribute to graft dysfunction, we recommend a urological follow-up after renal transplantation, using frequency/volume charts.

Current opinion on the working mechanisms of neuromodulation in the treatment of lower urinary tract dysfunction.

PURPOSE OF REVIEW: Neuromodulation is a successful treatment for patients with refractory lower urinary tract dysfunction. In the recent years, more applications of various types and ways have been developed and put into clinical practice. It is important, therefore, for urologists to know the existing theories on the working mechanisms that explain the effect. Although much research has been devoted to this subject for the past 35 years, the working mechanism is still unknown. This review presents an overview of the different theories and research into the physiological background of neuromodulation during the past 3 decades with emphasis on recent developments. RECENT FINDINGS: Specific receptors in the spinal cord have been identified, which are involved in the working mechanism of neuromodulation. The maximal effect of neuromodulation is not directly reached, indicating that neuromodulation induces learning changes (i.e. neural plasticity). The carry-over effect could be caused by negative modulation of excitatory synapses in the central micturition reflex pathway. SUMMARY: Neuromodulation in the treatment of stress incontinence probably induces physiological changes in the sphincter muscles and pelvic floor. In the treatment of overactive bladder syndrome, nonobstructive voiding dysfunction and chronic pelvic pain, the mechanism of action seems to be more complicated. Most likely, it is a combination of the different suggested modes of action, involving the neuroaxis at different levels.

The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms.

OBJECTIVES: We reviewed placebo responses in randomised controlled trials (RCTs) for pharmacologic treatment of lower urinary tract symptoms (LUTS), including urinary incontinence (UI), overactive bladder, and benign prostatic hyperplasia. Review papers on placebo effects in non-urologic disorders were assessed to compare the magnitude of placebo responses in drugs for LUTS with those reported for other diseases. METHODS: Data were retrieved from registration trials for LUTS drugs on the Web sites of the Food and Drugs Administration and the European Medicines Agency. Reviews were retrieved from Medline using the MeSH term "placebo effect" (English language; published between 1990 and 2005). RESULTS: Placebo treatment of LUTS yields reductions in incontinence episodes (IEs) ranging from 32% to 65%, whereas prostate or UI symptom scores are reduced by 9-34%. Genuine drugs decrease IEs by 45-77% and symptom scores by 22-45%. Placebo responses are much lower when objective changes in voided volume or peak flow rate are assessed. CONCLUSIONS: The placebo effect in LUTS has a strong behavioural component as patients become aware of their voiding habits and potential risk factors. Symptom severity, treatment naivety, study duration, and interaction with health care providers may also influence it. Proper patient selection, study duration, and objective and subjective outcome measures may better separate genuine treatment effects from artefacts. Observational studies with patients representative for real-life situations and covering a sufficient period of time could allow for better understanding of RCT results and their applicability in clinical practice.

Percutaneous tibial nerve stimulation in the treatment of refractory overactive bladder syndrome: is maintenance treatment necessary?

OBJECTIVE: To determine the effect of a pause in percutaneous tibial nerve stimulation (PTNS) in successfully treated patients with an overactive bladder (OAB), and the reproducibility of successful treatment when restored. PATIENTS AND METHODS: Eleven patients (mean age 51 years) with refractory OAB (more than seven voids and/or three or more urge incontinence episodes per day) were successfully treated with PTNS, and then discontinued treatment. Patients completed bladder diaries and quality-of-life (QoL) questionnaires (Short Form-36 and I-QoL) before (T1) and after a 6-week pause (T2) of maintenance PTNS, and again after re-treatment (T3). The first objective was defined as a > or = 50% increase in the incontinence episodes and/or voiding frequency in the bladder diary after T2. The second objective was defined as > or = 50% fewer incontinence episodes and/or voiding frequency in bladder diary after T3. RESULTS: At T2, seven of the 11 patients had a > or = 50% increase in incontinence episodes and/or voiding frequency in the bladder diary. The mean voided volume, nocturia, number of incontinence episodes and incontinence severity deteriorated significantly (P < 0.05). At T3, nine patients had > or = 50% fewer incontinence episodes and/or voiding frequency in the bladder diary. Nocturia, the number of incontinence episodes, incontinence severity, mean voided volume and quality of life improved significantly (P < 0.05). CONCLUSIONS: Continuous therapy is necessary in patients with OAB treated successfully by PTNS. The efficacy of PTNS can be reproduced in patients formerly treated successfully.

Correlation between quality of life and voiding variables in patients treated with percutaneous tibial nerve stimulation.

OBJECTIVE: To investigate the relationship between quality of life (QoL) and voiding variables in patients with lower urinary tract dysfunction treated with percutaneous tibial nerve stimulation (PTNS), as it is assumed that improvements in voiding will lead to a better QoL in such patients. PATIENTS AND METHODS: The study included 30 patients with urge urinary incontinence who were treated with PTNS; 24-h bladder diaries and QoL questionnaires (Short Form, SF-36, and incontinence-specific QoL) were completed at baseline and after PTNS. RESULTS: There was a significant correlation (P < 0.05) between the number of pads used and the SF-36 domains of physical and vitality, between the number of incontinence episodes and the SF-36 domains of physical and role physical, between nocturia and the SF-36 domains of general and mental health, between the mean voided volume and the SF-36 domains of role physical and final, and between the mean voided volume and the incontinence-specific QoL score. CONCLUSIONS: PTNS is useful for treating refractory urge incontinence and should at least be considered as a therapeutic alternative before resorting to aggressive surgery, as voiding and QoL variables significantly and quantifiably correlate in patients with refractory urge urinary incontinence who are treated with PTNS. Patients must have a reduction of >or = two pads/day before their QoL improves, and this might be the best definition of successful therapy for patients with urge urinary incontinence.

Implant-Driven Tibial Nerve Stimulation in the Treatment of Refractory Overactive Bladder Syndrome: 12-Month Follow-up.

Objectives. To investigate feasibility and safety of implant-driven tibial nerve stimulation. Materials and Methods. Eight patients with refractory overactive bladder were successfully treated with implanted percutaneous tibial nerve stimulation (PTNS). Patients were evaluated with bladder diaries, quality of life questionnaires, and physical examination before implantation, and at 3, 6, and 12 months of follow-up. The primary objective was ≥ 50% reduction of the number of incontinence episodes and/or voids on bladder diary. The Wilcoxon signed ranks test was used. Results. At 3, 6 and 12 months, respectively five, six, and four patients met the primary objective. At 3- and 6-month follow-up, voiding and quality of life parameters had significantly (p < 0.05) improved. Urinary tract infection, temporarily walking difficulties, and spontaneous radiating sensations were reported as adverse events and no local infection, erosion, or dislocation. Conclusions. Implant-driven tibial nerve stimulation seems to be feasible and safe.

Undertreatment of urinary incontinence in general practice.

BACKGROUND: In the urinary incontinence guidelines that are issued by the Dutch College of General Practitioners, treatment guidelines are related to the type of incontinence. It is unknown whether treatment of urinary incontinence in general practice complies with these guidelines. OBJECTIVE: To describe treatment patterns and costs of urinary incontinence. METHODS: The source population for this retrospective cohort study included all women aged > or =40 years in the Integrated Primary Care Information general practice research database. Women were included in the final study cohort if they were newly identified as being urinary incontinent during the study period (1998-2000) and had at least one year of follow-up after the first diagnosis/treatment. The type of incontinence, treatment course, and costs of incontinence were assessed during the first year after the subjects' identification. RESULTS: The final study cohort comprised 1663 women (mean age 68.5 y). Overall, 71% of newly identified women with urinary incontinence did not receive active treatment within one year after identification. In 13%, the first treatment was bladder training or pelvic floor exercises, and 11% started treatment with a bladder relaxant drug. First treatment was related to the type of incontinence; however, in <50% of the women, the type of incontinence was reported or could be assessed. Absorbent products were used by 66% of the women; 87% of them received no active treatment. The mean direct costs of urinary incontinence over the first year amounted to 392 per woman, of which 200 (51%) for absorbent products. CONCLUSIONS: Less than one-third of the women with newly identified urinary incontinence were actively treated for their incontinence. Although treatment patterns were in line with guidelines, the high rate of undertreatment points to the need for better patient and physician education.

The prevalence of urinary incontinence in community-dwelling married women: a matter of definition.

OBJECTIVE: To determine the prevalence of female urinary incontinence (UI) and its impact on quality of life. SUBJECTS AND METHODS: In a Dutch national postal questionnaire survey, 1460 spouses of 1771 men in the town of Boxmeer, age-stratified and randomly selected, were asked to participate. The prevalence of UI in the women was assessed in two ways. First, a total score on a short UI-specific questionnaire differentiated them into three groups, i.e. no symptoms (score 0-2), minimally (3-6) or severely incontinent (7-14). Second, a self-reported UI prevalence was calculated by asking respondents if they ever had urine loss. To conform to the International Continence Society standard definition, spouses were also asked to complete a general (Short Form-12) and lower urinary tract disease-specific quality-of-life questionnaire, and were asked about their need to seek help. RESULTS: The questionnaires were returned by 1071 women (mean age 57 years, range 29-79; response rate 73%); 34% were regarded as minimally and 12% as severely incontinent. The self-reported UI rate was 40%. Disease-specific and general quality of life was significantly lower for women with UI than for those with minimal or no urine loss; 38% of incontinent respondents had consulted a physician for their UI, and among respondents with minimal complaints this was 28%. CONCLUSIONS: Up to 46% of the married female population had some degree of UI, and severe UI significantly compromised their quality of life.

The use of electrical devices for the treatment of bladder dysfunction: a review of methods.

PURPOSE: We reviewed the literature on the application of various devices and techniques for the electrical stimulation treatment of lower urinary tract dysfunction with respect to mechanism of action and clinical outcome. MATERIALS AND METHODS: A systematic review was done in PubMed of publications on intravesical stimulation, direct bladder stimulation, stimulation of the pelvic and pudendal nerves, transcutaneous-electrical nerve stimulation, stimulation of the sacral spine and roots, and lower limb stimulation. RESULTS: It is difficult truly to compare different treatment modalities because there are hardly any randomized placebo controlled studies. Also, there is considerable variety in treatment parameters and schedules reported as well as in criteria for success. Nevertheless, it can be said that electrical neurostimulation and neuromodulation result in a 30% to 50% clinical success on an intent to treat basis. Influencing lower urinary tract innervation at the level of sacral roots seems successful in neurological and nonneurological cases. It has the advantage of pretesting possibilities to improve patient selection and treatment outcome with the obvious drawback of invasiveness. Noninvasive techniques lack screening tests, making patient selection a matter of trial and error, and when there is success patients almost always need maintenance therapy. CONCLUSIONS: Randomized clinical trials to compare different techniques and evaluate placebo effects are urgently needed, as are further studies to elucidate modes of action to improve stimulation application and therapy results. The introduction of new stimulation methods may provide treatment alternatives as well as help answer more basic questions on electrical neurostimulation and neuromodulation.

Posterior tibial nerve stimulation in the treatment of voiding dysfunction: urodynamic data.

OBJECTIVES: To determine urodynamic changes and predictive factors in patients with voiding dysfunction who underwent 12 percutaneous tibial nerve stimulations. METHODS: Thirty nine patients with chronic voiding dysfunction were enrolled in a prospective multicenter trial in the Netherlands (n = 19) and in Italy (n = 20). A 50% reduction in total catheterised volume per 24 hr was taken as a primary objective outcome measure. Patients' request for continuation of treatment was regarded as subjective success. Objective urodynamic parameters and bladder indices were determined. Odds ratios and their 95% confidence interval were computed as a measure for predictive power in order to reveal predictive factors (Pdet at Qmax, Qmax, BVE, and BCI). RESULTS: Primary outcome measure was obtained in 41%, an additional 26% reduced their 24 hr residuals with more than 25%. Fifty nine percent of patients chose to continue treatment. Detrusor pressure at maximal flow, cystometric residuals, and bladder indices improved significantly for all patients (P < 0.05). Patients with minor voiding dysfunction were more prone to notice success (Odds ratio: 0.73; 95% CI: 0.51-0.94). CONCLUSIONS: PTNS is a young treatment modality, minimally invasive, and easily accessible. It might be an attractive first line option for patients with (minor) voiding dysfunction.