Photodynamic versus white light-guided treatment of non-muscle invasive bladder cancer: a study protocol for a randomised trial of clinical and cost-effectiveness.

INTRODUCTION: Bladder cancer is the most frequently occurring tumour of the urinary system. Ta, T1 tumours and carcinoma in situ (CIS) are grouped as non-muscle invasive bladder cancer (NMIBC), which can be effectively treated by transurethral resection of bladder tumour (TURBT). There are limitations to the visualisation of tumours with conventional TURBT using white light illumination within the bladder. Incomplete resections occur from the failure to identify satellite lesions or the full extent of the tumour leading to recurrence and potential risk of disease progression. To improve complete resection, photodynamic diagnosis (PDD) has been proposed as a method that can enhance tumour detection and guide resection. The objective of the current research is to determine whether PDD-guided TURBT is better than conventional white light surgery and whether it is cost-effective. METHODS AND ANALYSIS: PHOTO is a pragmatic multicentre randomised controlled trial (open parallel group, non-masked and superiority trial) comparing the intervention of PDD-guided TURBT with standard white light resection in newly diagnosed intermediate and high risk NMIBC within the UK National Health Service setting. Clinical effectiveness is measured with time to recurrence. Cost-effectiveness is assessed within trial via the calculation of incremental cost per recurrence avoided and incremental cost per quality-adjusted life per year gained over 3 years and over long term through a modelling exercise over patients' lifetime. ETHICS AND DISSEMINATION: Formal ethics review was undertaken with a favourable opinion, in line with UK regulatory procedures (REC reference number: 14/NE/1062). If reductions in time to recurrence is associated with long-term patient benefits, the cost-effectiveness evaluation will provide further evidence to inform adoption of the technology. Findings will be shared in lay media such as patient and charity forums and will be presented at key meetings and published in academic literature.Trial registration number ISRCTN84013636.

Pruebas diagnósticas en urología: ¿será la ganancia diagnóstica suficiente, para la evaluación de la linfadenectomía ampliada en cáncer de próstata? / Diagnostic tests in urology: is the diagnostic gain sufficient to assess extended lymphadenectomy in prostate cancer?

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The cost of preoperative urodynamics: A secondary analysis of the ValUE trial.

AIMS: Urodynamic studies (UDS) are generally recommended prior to surgical treatment for stress urinary incontinence (SUI), despite insufficient evidence that it impacts treatment plans or outcomes in patients with uncomplicated SUI. This analysis aimed to calculate the cost incurred when UDS was performed as a supplement to a basic office evaluation and to extrapolate the potential savings of not doing UDS in this patient population on a national basis. METHODS: This is a secondary analysis from the Value of Urodynamic Evaluation (ValUE) trial, a multicenter non-inferiority randomized trial to determine whether a basic office evaluation (OE) is non-inferior in terms of SUI surgery outcomes to office evaluation with addition of urodynamic studies (UDS). All participants underwent an OE; those patients who randomized to supplementary UDS underwent non-instrumented uroflowmetry, filling cystometry, and a pressure flow study. Costs associated with UDS were calculated using 2014 U.S. Medicare allowable fees. Models using various patient populations and payor mixes were created to obtain a range of potential costs of performing UDS in patients undergoing SUI surgery annually in the United States. RESULTS: Six hundred thirty women were randomized to OE or OE plus UDS. There was no difference in surgical outcomes between the two groups. The per patient cost of UDS varied from site to site, and included complex cystometrogram $314-$343 (CPT codes 51728-51729) plus complex uroflowmetry $16 (CPT code 51741). Extrapolating these costs for US women similar to our study population, 13-33 million US dollars could be saved annually by not performing preoperative urodynamics. CONCLUSION: For women with uncomplicated SUI and a confirmatory preoperative basic office evaluation, tens of millions of dollars US could be saved annually by not performing urodynamic testing. In the management of such women, eliminating this preoperative test has a major economic benefit.

A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study.

BACKGROUND: The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). METHODS: A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians' views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here. Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm). The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment. RESULTS: Of 284 eligible women, 222 (78%) were recruited, 165/219 (75%) returned questionnaires at baseline, and 125/200 returned them (63%) at follow-up. Most women underwent surgery; management plans were changed in 19 (19%) participants following IUT. Participants interviewed were positive about the trial and the associated documentation. CONCLUSIONS: All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): a mixed-methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing prior to surgery for stress urinary incontinence in women.

BACKGROUND: The position of invasive urodynamic testing in the diagnostic pathway for urinary incontinence (UI) is unclear. Systematic reviews have called for further trials evaluating clinical utility, although a preliminary feasibility study was considered appropriate. OBJECTIVES: To inform the decision whether or not to proceed to a definitive randomised trial of invasive urodynamic testing compared with clinical assessment with non-invasive tests, prior to surgery in women with stress UI (SUI) or stress predominant mixed UI (MUI). DESIGN: A mixed-methods study comprising a pragmatic multicentre randomised pilot trial; economic evaluation; survey of clinicians' views about invasive urodynamic testing; qualitative interviews with clinicians and trial participants. SETTING: Urogynaecology, female urology and general gynaecology units in Newcastle, Leicester, Swansea, Sheffield, Northumberland, Gateshead and South Tees. PARTICIPANTS: Trial recruits were women with SUI or stress predominant MUI who were considering surgery after unsuccessful conservative treatment. Relevant clinicians completed two online surveys. Subsets of survey respondents and trial participants took part in separate qualitative interview studies. INTERVENTIONS: Pilot trial participants were randomised to undergo clinical assessment with non-invasive tests (control arm); or assessment as controls, plus invasive urodynamic testing (intervention arm). MAIN OUTCOME MEASURES: Confirmation that units can identify and recruit eligible women; acceptability of investigation strategies and data collection tools; acquisition of outcome data to determine the sample size for a definitive trial. The proposed primary outcome for the definitive trial was International Consultation on Incontinence Modular Questionnaire (ICIQ) Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) (total score) 6 months after surgery or the start of non-surgical treatment; secondary outcomes included: ICIQ-FLUTS (subscales); ICIQ Urinary Incontinence Short Form; ICIQ Lower Urinary Tract Symptoms Quality of Life; Urogenital Distress Inventory; EuroQol-5D; costs, quality-adjusted life-years (QALYs) and incremental cost per QALY, Short Form 12; 3-day bladder diary. RESULTS: Of 284 eligible women, 222 (78%) were recruited; 165/219 (75%) returned questionnaires at baseline and 125/200 (63%) who were sent questionnaires at follow-up. There were few missing data items in returned questionnaires, with individual outcome scales calculable for 81%-94%. Most women underwent surgery; management plans were changed in 19 (19%) participants following invasive urodynamic testing. Participant Costs Questionnaires were returned by 53% 6 months after treatment; complete data to undertake cost-utility analysis were available in 27% (intervention) and 47% (control). While insufficient to recommend changes in practice, the results suggest further research would be valuable. All clinicians responding to the survey had access to invasive urodynamic testing, and most saw it as essential prior to surgery in women with SUI with or without other symptoms; nevertheless, 70% considered the research question underlying INVESTIGATE important and most were willing to randomise patients in a definitive trial. Participants interviewed were positive about the trial and associated documentation; the desire of some women to avoid invasive urodynamic testing contrasted with opinions expressed by clinicians through both survey and interview responses. CONCLUSIONS: All elements of a definitive trial and economic evaluation were rehearsed; several areas for protocol modification were identified. Such a trial would require to 400-900 participants, depending on the difference in primary outcome sought. FUTURE WORK: A definitive trial of invasive urodynamic testing versus clinical assessment prior to surgery for SUI or stress predominant MUI should be undertaken. TRIAL REGISTRATION: Current Controlled Trials ISRCTN71327395. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Análisis coste-efectividad de las principales herramientas diagnósticas en mujeres con vejiga hiperactiva: historia clínica, diario miccional y estudio urodinámico / Cost-effectiveness analysis of main diagnosis tools in women with overactive bladder. Clinical history, micturition diary and urodynamic study

Objetivos: El presente trabajo de investigación clínica pretende analizar a la luz de la mejor evidencia científica el rendimiento y el coste de las principales herramientas utilizadas en el diagnóstico de la vejiga hiperactiva (VH). Métodos: Se trata de un estudio transversal exploratorio y analítico, en el cual se seleccionó una muestra de 199 mujeres diagnosticadas de VH entre los años 2006 y 2008, a las que se realizó de forma prospectiva: exploración física, análisis de orina, diario miccional (DM) y estudio urodinámico (EUD). Se asumió que un porcentaje de diagnóstico altamente sensible debería ser 80% y que una diferencia de diagnóstico del 10% entre las pruebas sería clínicamente relevante. Se determinó estadísticamente la sensibilidad de cada una de las pruebas de forma aislada y combinada para el diagnóstico de VH y una valoración de los recursos económicos directos e indirectos que conlleva su realización, analizándose el coste efectividad de la historia clínica (HC), DM y EUD para el diagnóstico de VH. Resultados: La sensibilidad global para el diagnóstico de VH es baja para cualquiera de las pruebas utilizadas de forma aislada, mientras que la combinación de 2 pruebas cualesquiera presenta una buena sensibilidad global para su diagnóstico. La combinación de HC y DM es la alternativa más coste efectiva en el diagnóstico de VH. Conclusiones: El uso de HC y DM es una combinación tan sensible para el diagnóstico de la VH como la asociación de cualquiera de ellas con el EUD, presentando además un menor coste económico

Objetives: The aim of the present clinical research is to analyze, in the light of the best scientific evidence, the performance and the cost of the main diagnostic tools for overactive bladder (OAB). Methods: It is an exploratory transversal study in which 199 women diagnosed of OAB between 2006 and 2008 were selected and underwent to following prospective analyses: physical examination, urine analysis, micturition diary (MD) and urodynamic study (UDS). A percentage of 80% was assumed as highly sensitive and a diagnostic difference among tests of 10% would be considered clinically relevant. Tests’ sensitivity for diagnosis of OAB was statistically established by two ways: isolated and combined. Besides, the direct and indirect costs of these tests performance were conducted. Cost-effectiveness study of clinical history (CH), MD and US for the diagnosis of OAB was performed. Results: Overall sensitivity for OAB diagnosis is low for the 3 tests used in isolated way, whilst the combination of any two tests shows good overall sensitivity. The combination of CH and MD has appeared as the most cost-effective alternative to OAB diagnosis. Conclusions: For OAB diagnosis, CH-DM combination shows the same sensitivity than the association of either of them with the UDS, but unlike to these, it shows the lowest cost

Routine pathology evaluation of hydrocele and spermatocele specimens is associated with significant costs and no identifiable benefit.

PURPOSE: Hydrocelectomy and spermatocelectomy are routine scrotal surgeries. A significant number of the surgical specimens are sent for pathology analysis. However, to our knowledge no study has been done to examine outcomes and necessity, which results in significant potentially unnecessary costs to the patient and the health care system. We evaluated outcomes and surgical pathology analysis of hydroceles and spermatoceles. MATERIALS AND METHODS: We performed a retrospective, single institution chart review of all patients who underwent initial surgery for hydrocele or spermatocele between January 2000 and August 2013. We determined the number of cases in which a surgical specimen was sent for pathology examination. The cost for each specimen was estimated at the department of pathology. RESULTS: A total of 264 routine scrotal cases were performed during the 14-year period. Surgical specimens were sent for pathology analysis in 102 hydrocelectomy cases (51%) and in 57 spermatocelectomy cases (90%). No pathology specimen showed any indication of malignancy. The estimated direct total cost of pathology analysis was $49,449 in this cohort. CONCLUSIONS: No malignancy was detected in 159 hydrocele and spermatocele specimens during the 14 study years, suggesting that the pathology analysis is of little clinical benefit. Forgoing surgical pathology analysis of these specimens would result in significant cost savings to the patient and the health care system.

The economics of bladder cancer: costs and considerations of caring for this disease.

CONTEXT: Due to high recurrence rates, intensive surveillance strategies, and expensive treatment costs, the management of bladder cancer contributes significantly to medical costs. OBJECTIVE: To provide a concise evaluation of contemporary cost-related challenges in the care of patients with bladder cancer. An emphasis is placed on the initial diagnosis of bladder cancer and therapy considerations for both non-muscle-invasive bladder cancer (NMIBC) and more advanced disease. EVIDENCE ACQUISITION: A systematic review of the literature was performed using Medline (1966 to February 2011). Medical Subject Headings (MeSH) terms for search criteria included "bladder cancer, neoplasms" OR "carcinoma, transitional cell" AND all cost-related MeSH search terms. Studies evaluating the costs associated with of various diagnostic or treatment approaches were reviewed. EVIDENCE SYNTHESIS: Routine use of perioperative chemotherapy following complete transurethral resection of bladder tumor has been estimated to provide a cost savings. Routine office-based fulguration of small low-grade recurrences could decrease costs. Another potential important target for decreasing variation and cost lies in risk-modified surveillance strategies after initial bladder tumor removal to reduce the cost associated with frequent cystoscopic and radiographic procedures. Optimizing postoperative care after radical cystectomy has the potential to decrease length of stay and perioperative morbidity with substantial decreases in perioperative care expenses. The gemcitabine-cisplatin regimen has been estimated to result in a modest increase in cost effectiveness over methotrexate, vinblastine, doxorubicin, and cisplatin. Additional costs of therapies need to be balanced with effectiveness, and there are significant gaps in knowledge regarding optimal surveillance and treatment of both early and advanced bladder cancer. CONCLUSIONS: Regardless of disease severity, improvements in the efficiency of bladder cancer care to limit unnecessary interventions and optimize effective cancer treatment can reduce overall health care costs. Two scenarios where economic and comparative-effectiveness research is limited but would be most beneficial are (1) the management of NMIBC patients where excessive costs are due to vigilant surveillance strategies and (2) in patients with metastatic disease due to the enormous cost associated with late-stage and end-of-life care.

[Development of the 2014 G-DRG system. Departure from coding of secondary diagnoses?]. / Entwicklung des G-DRG-Systems 2014. Abkehr von der Kodierung der Nebendiagnosen?

The objective of the German DRG (diagnosis-related groups) system is to adequately reimburse hospital costs using flat rate payments. The goal is to thereby achieve the most adequate representation of hospital costs in flat rate payments. The DRG for 2014 is based on the actual number of cases treated and the costs determined from 2012. For 2014, the current changes of the DRG system for the specialty urology concerning the coding and recording of secondary diagnoses are presented and discussed.

Screening for malignancy after augmentation cystoplasty in children with spina bifida: a decision analysis.

PURPOSE: Augmentation cystoplasty is the mainstay of surgical treatment for medically refractory neurogenic bladder in patients with spina bifida. Concerns regarding an increased risk of malignancy have prompted many centers to consider routine postoperative screening. We examine the potential cost-effectiveness of such screening. MATERIALS AND METHODS: A Markov model was used to compare 2 screening strategies among patients with spina bifida after cystoplasty, namely annual screening cystoscopy and cytology and usual care. Model parameters were informed via a systematic review of post-augmentation malignancy and cost estimates from published reports or government sources. RESULTS: In a hypothetical cohort the individual increase in life expectancy for the entire cohort was 2.3 months with an average lifetime cost of $55,200 per capita, for an incremental cost-effectiveness ratio of $273,718 per life-year gained. One-way and two-way sensitivity analyses suggest the screening strategy could be cost effective if the annual rate of cancer development were more than 0.26% (12.8% lifetime risk) or there were a greater than 50% increase in screening effectiveness and cancer risk after augmentation. After adjusting for multiple levels of uncertainty the screening strategy had only an 11% chance of being cost effective at a $100,000 per life-year threshold or a less than 3% chance of being cost effective at $100,000 per quality adjusted life-year. CONCLUSIONS: Annual screening for malignancy among patients with spina bifida with cystoplasty using cystoscopy and cytology is unlikely to be cost effective at commonly accepted willingness to pay thresholds. This conclusion is sensitive to a higher than expected risk of malignancy and to highly optimistic estimates of screening effectiveness.

Urologist practice styles in the initial evaluation of elderly men with benign prostatic hyperplasia.

OBJECTIVES: To investigate the degree to which expenditures on symptom evaluations vary among urologists and the factors associated with such variation. As the medical and surgical specialists for men with lower urinary tract symptoms (LUTS), urologists provide testing to evaluate symptoms and determine therapy. METHODS: We developed a cohort of men with an initial urologist visit for benign prostatic hyperplasia (BPH) from a 5% sample of Medicare patients (1999-2007) and established a physician level factor, practice style, as a function of average per patient expenditures. We then determined which AUA BPH guideline elements explained variation in quantity and expenditures for BPH testing, and also examined the impact of patient and physician factors on practice style. RESULTS: A nearly 15-fold variation in urologists' average per-patient expenditures existed ($35 to $527 per month; Median $92). Practice styles were associated with physician (P < .01 all examined variables) and patient (P < .01 for comorbidity, race/ethnicity, and socioeconomic status) factors. Guideline recommended care was provided at lower rates by the lowest expenditure urologists compared with middle- to highest-intensity urologists (P < .01). Practice style variations were attributable mainly to differences in tests characterized by the guidelines as optional and not-recommended (P < .01). CONCLUSIONS: Expenditures for BPH evaluations vary substantially by geography, practice setting, and experience and are accounted for largely by differences in the use of optional and not-routinely recommended tests. Greater standardization could enhance patient care and reduce health care costs.

Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer.

OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis (PDD) compared with white light cystoscopy (WLC), and urine biomarkers [fluorescence in situ hybridisation (FISH), ImmunoCyt, NMP22] and cytology for the detection and follow-up of bladder cancer. DATA SOURCES: Major electronic databases including MEDLINE, MEDLINE In-Process, EMBASE, BIOSIS, Science Citation Index, Health Management Information Consortium and the Cochrane Controlled Trials Register were searched until April 2008. REVIEW METHODS: A systematic review of the literature was carried out according to standard methods. An economic model was constructed to assess the cost-effectiveness of alternative diagnostic and follow-up strategies for the diagnosis and management of patients with bladder cancer. RESULTS: In total, 27 studies reported PDD test performance. In pooled estimates [95% confidence interval (CI)] for patient-level analysis, PDD had higher sensitivity than WLC [92% (80% to 100%) versus 71% (49% to 93%)] but lower specificity [57% (36% to 79%) versus 72% (47% to 96%)]. Similar results were found for biopsy-level analysis. The median sensitivities (range) of PDD and WLC for detecting lower risk, less aggressive tumours were similar for patient-level detection [92% (20% to 95%) versus 95% (8% to 100%)], but sensitivity was higher for PDD than for WLC for biopsy-level detection [96% (88% to 100%) versus 88% (74% to 100%)]. For more aggressive, higher-risk tumours the median sensitivity of PDD for both patient-level [89% (6% to 100%)] and biopsy-level [99% (54% to 100%)] detection was higher than those of WLC [56% (0% to 100%) and 67% (0% to 100%) respectively]. Four RCTs comparing PDD with WLC reported effectiveness outcomes. PDD use at transurethral resection of bladder tumour resulted in fewer residual tumours at check cystoscopy [relative risk, RR, 0.37 (95% CI 0.20 to 0.69)] and longer recurrence-free survival [RR 1.37 (95% CI 1.18 to 1.59)] compared with WLC. In 71 studies reporting the performance of biomarkers and cytology in detecting bladder cancer, sensitivity (95% CI) was highest for ImmunoCyt [84% (77% to 91%)] and lowest for cytology [44% (38% to 51%)], whereas specificity was highest for cytology [96% (94% to 98%)] and lowest for ImmunoCyt [75% (68% to 83%)]. In the cost-effectiveness analysis the most effective strategy in terms of true positive cases (44) and life-years (11.66) [flexible cystoscopy (CSC) and ImmunoCyt followed by PDD in initial diagnosis and CSC followed by WLC in follow-up] had an incremental cost per life-year of over 270,000 pounds. The least effective strategy [cytology followed by WLC in initial diagnosis (average cost over 20 years 1403 pounds, average life expectancy 11.59)] was most likely to be considered cost-effective when society's willingness to pay was less than 20,000 pounds per life-year. No strategy was cost-effective more than 50% of the time, but four of the eight strategies in the probabilistic sensitivity analysis (three involving a biomarker or PDD) were each associated with a 20% chance of being considered cost-effective. In sensitivity analyses the results were most sensitive to the pretest probability of disease (5% in the base case). CONCLUSIONS: The advantages of PDD's higher sensitivity in detecting bladder cancer have to be weighed against the disadvantages of a higher false-positive rate. Taking into account the assumptions made in the model, strategies involving biomarkers and/or PDD provide additional benefits at a cost that society might be willing to pay. Strategies replacing WLC with PDD provide more life-years but it is unclear whether they are worth the extra cost.

Radiological investigations following urinary tract infection: changes in Australian practice.

OBJECTIVE: To examine practice changes in the conduct of radiological investigations in Australia following urinary tract infection (UTI). DESIGN: Observational study using data from the national Medicare database over the 15-year period July 1993 to June 2008 for four investigations: renal ultrasound (renal US), micturating cystourethrography (MCU), intravenous pyelography (IVP) and nuclear medicine isotope scanning of the renal tract (NM). Rates per 100,000 children in the age groups 0-4 years and 5-14 years were calculated for each test. SETTING: Australian medical practice, including private and public medical settings. RESULTS: The rates of performance of renal US remained fairly constant throughout the study period in both age groups, while those for MCU, IVP and NM showed a strong falling trend over time for each test in both age groups. For the more invasive tests (MCU, IVP and NM) the total number performed per annum fell from 11,169 (costing 2,032,621 dollars) to 3361 (costing 689,742 dollars) in the last 10 years. CONCLUSION: There have been very marked practice changes over the last 10-15 years. This trend followed the publication of scientific evidence which has raised doubts about the benefit of performing these investigations.

Photodynamic diagnostics of bladder tumors.

Approximately 18,000 new cases of urothelial cancer of the bladder occur annually, making it the most frequent urogenital neoplasia representing nearly 4% of all malignomas. Tumor stage defines two subgroups requiring specific therapeutic approaches and implying distinct prognoses. Non-muscle-invasive urothelial cancer recurs frequently and occasionally progresses to muscle-invasive stages. Remnant tumor after initial resection is seen as one major factor in high recurrence rates. Although photodynamic diagnostics improving detection and increasing recurrence-free survival has been introduced to broad application, it has yet not been established as standard procedure. This article reviews the current literature and discusses controversial aspects.

The poppy seed test for colovesical fistula: big bang, little bucks!

PURPOSE: Diagnosis of a colovesical fistula is often challenging, and usually involves numerous invasive and expensive tests and procedures. The poppy seed test stands out as an exception to this rule. We evaluated the accuracy and cost-effectiveness of various established diagnostic tests used to evaluate a suspected colovesical fistula. MATERIALS AND METHODS: We identified 20 prospectively entered patients with surgically confirmed colovesical fistulas between 2000 and 2006. Each patient was evaluated preoperatively with a (51)chromium nuclear study, computerized tomography of the abdomen and pelvis with oral and intravenous contrast medium, and the poppy seed test. Costs were calculated using institutional charges, 2006 Medicare limiting approved charges and the market price, respectively. The z test was used to compare the proportion of patients who tested positive for a fistula with each of these modalities. RESULTS: The chromium study was positive in 16 of 20 patients (80%) at a cost of $490.83 per study. Computerized tomography was positive in 14 of 20 patients (70%) at a cost of $652.92 per study. The poppy seed test was positive in 20 of 20 patients (100%) at a cost of $5.37 per study. The difference in the proportion of patients who tested positive for a fistula on computerized tomography and the poppy seed test was statistically significant (p = 0.03). There was no difference between the chromium group and the computerized tomography or poppy seed group (p = 0.72 and 0.12, respectively). CONCLUSIONS: The poppy seed test is an accurate, convenient and inexpensive diagnostic test. It is an ideal initial consideration for evaluating a suspected colovesical fistula.

Análisis prospectivo y comparativo entre la resonancia magnética y las exploraciones tradicionales utilizadas en el estudio de las uropatías con afectación funcional del niño / Comparison between MRI and the techniques traditionally used in the study of uropathies in children

Objetivo. Correlacionar la información anatómica y funcional obtenida mediante la resonancia magnética (RM) frente a las técnicas que se utilizan tradicionalmente en la estudio de las uropatías, y comparar sus repercusiones físicas y socio-económicas. Material y método. Durante un período de 11 meses fueron estudiados prospectivamente 22 pacientes de ambos sexos y edades comprendidas entre 1 y 180 meses, afectos de diversos tipos de uropatía. 55% de los pacientes procedían de la consulta externa y el 45% tuvieron diagnóstico prenatal. Las técnicas de imagen comparadas con la RM fueron: ecografía, renograma, gammagrafía, urografía y cistografía. Para la RM se utilizó gadolinio y en algunos casos anestesia general. Resultados. Existió una correlación significativa (r= 0,942 p < 0,01) entre la RM y las exploraciones tradiciones para los diagnósticos de hidronefrosis, riñón en herradura, duplicidad renal, hipoplasia e hipertrofia renal, riñón multiquístico, ureterocele, estenosis pieloureteral, estenosis vesicoureteral, atrofia de la arteria renal y ausencia renal. No fue útil para reflujo. Comparando con la función renal diferencial del renograma existió un 86% de concordancia en los resultados. El promedio de número de visitas fue de 5,7 y de ausencias laborales 4,1. El costo motivado por la RM respecto del resto de exploraciones, fue menor (Chi2= 27,909 p < 0,001). Conclusiones. La RM aporta la misma información morfológica y de función cualitativa, que la obtenida con las exploraciones tradicionales, además de la vascular. La irradiación de la RM es nula. En ocasiones precisa anestesia. Su práctica disminuye gastos, visitas, faltas laborales y desplazamientos. En un futuro, si en el curso de la misma se logra realizar la cistografía y la sobrecarga hídrica/diurética se incrementará su eficacia (AU)

Objetivo. Correlacionar la información anatómica y funcional obtenida mediante la resonancia magnética (RM) frente a las técnicas que se utilizan tradicionalmente en la estudio de las uropatías, y comparar sus repercusiones físicas y socio-económicas. Material y método. Durante un período de 11 meses fueron estudiados prospectivamente 22 pacientes de ambos sexos y edades comprendidas entre 1 y 180 meses, afectos de diversos tipos de uropatía. 55% de los pacientes procedían de la consulta externa y el 45% tuvieron diagnóstico prenatal. Las técnicas de imagen comparadas con la RM fueron: ecografía, renograma, gammagrafía, urografía y cistografía. Para la RM se utilizó gadolinio y en algunos casos anestesia general. Resultados. Existió una correlación significativa (r= 0,942 p < 0,01) entre la RM y las exploraciones tradiciones para los diagnósticos de hidronefrosis, riñón en herradura, duplicidad renal, hipoplasia e hipertrofia renal, riñón multiquístico, ureterocele, estenosis pieloureteral, estenosis vesicoureteral, atrofia de la arteria renal y ausencia renal. No fue útil para reflujo. Comparando con la función renal diferencial del renograma existió un 86% de concordancia en los resultados. El promedio de número de visitas fue de 5,7 y de ausencias laborales 4,1. El costo motivado por la RM respecto del resto de exploraciones, fue menor (Chi2= 27,909 p < 0,001). Conclusiones. La RM aporta la misma información morfológica y de función cualitativa, que la obtenida con las exploraciones tradicionales, además de la vascular. La irradiación de la RM es nula. En ocasiones precisa anestesia. Su práctica disminuye gastos, visitas, faltas laborales y desplazamientos. En un futuro, si en el curso de la misma se logra realizar la cistografía y la sobrecarga hídrica/diurética se incrementará su eficacia (AU)

Photodynamic diagnostics and noninvasive bladder cancer: is it cost-effective in long-term application? A Germany-based cost analysis.

OBJECTIVES: Noninvasive urothelial carcinoma of the bladder (UCB) causes an enormous economic burden to public health systems due to its life-long character and frequent recurrences. While white light (WL) cystoscopy is considered to be the gold standard for transurethral resection of the bladder, photodynamic diagnostic (PDD) has been shown to improve final outcome. Escalating healthcare costs warrant increased effectiveness in treating noninvasive UCB. No data based on assessment of costs have been published to date. METHODS: A series of 301 patients with noninvasive UCB were randomized prospectively to standard WL or PDD transurethral resections of the bladder. Intravesical adjuvant therapy was administered as reflected in the appropriate guidelines. Expenditures of subsequent procedures and PDD-associated costs were assessed. RESULTS: Median follow-up was 7.1 yr. Disease recurrence was found in 42% and 18% of WL and PDD patients, respectively (p=0.0003). In the WL group 2.0 and in the PDD group 0.8 transurethral resections of the bladder were noted per patient. In the WL group 1.0 and in the PDD group 0.3 recurring UCB occurred per patient, resulting in costs of 1750 euro per WL patient versus 420 euro per PDD patient in the follow-up period, respectively. Because a single expenditure of 135 euro was assessed for PDD, overall costs were significantly lower (by 1195 euro) in PDD patients. As the median follow-up was 7.1 yr, costs saved by PDD per patient per year were 168 euro. CONCLUSION: Our data suggest that PDD significantly cut costs related to recurring UCB. Further studies are needed from an economic point of view.

NMP22 BladderChek Test: point-of-care technology with life- and money-saving potential.

A new, relatively obscure tumor marker assay, the NMP22 BladderChek Test (Matritech, Inc.), represents a paradigm shift in the diagnosis and management of urinary bladder cancer (transitional cell carcinoma). Specifically, BladderChek should be employed every time a cystoscopy is performed, with corresponding changes in the diagnostic protocol and the guidelines of the American Urological Association for the diagnosis and management of bladder cancer. Currently, cystoscopy is the reference standard and NMP22 BladderChek Test in combination with cystoscopy improves the performance of cystoscopy. At every stage of disease, BladderChek provides a higher sensitivity for the detection of bladder cancer than cytology, which now represents the adjunctive standard of care. Moreover, BladderChek is four-times more sensitive than cytology and is available at half the cost. Early detection of bladder cancer improves prognosis, quality of life and survival. BladderChek may be analogous to the prostate-specific antigen test and eventually expand beyond the urologic setting into the primary care setting for the testing of high-risk patients characterized by smoking history, occupational exposures or age.