Union rates and functional outcome of double plating of the femur: systematic review of the literature.

BACKGROUND: The optimal treatment strategy for the surgical management of femur fractures and non-unions remains unknown. The aim of this study is to assess union rates, complications and outcome after femoral double plating. Treatment of shaft, distal, periprosthetic fractures and pathological proximal femur fractures as well as femoral non-unions with double plating were evaluated. METHODS: A systematic review according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement was conducted. Published literature reporting on the treatment and clinical outcome of femoral fractures and non-unions with double plating was identified. In total, 24 studies with 436 cases of double plating, 64 cases of single plating, 84 cases of intramedullary nailing (IM), and 1 interfragmentary screw treatment met the inclusion criteria of this systematic review. The evaluated literature was published between 1991 and 2020. RESULTS: Double plating of femoral fractures achieved high healing rates and few complications were reported. It displayed significantly less intraoperative haemorrhage, shorter surgery time reduced risk of malunion in polytraumatised patients when compared to IM. Fracture healing rate of double-plating distal femoral fractures was 88.0%. However, there were no significant differences regarding fracture healing, complication or functional outcome when compared to single plating. Treatment of periprosthetic fractures with double plating displayed high healing rates (88.5%). Double plating of non-unions achieved excellent osseous union rates (98.5%). CONCLUSIONS: The literature provides evidence for superior outcomes when using double plating in distal femoral fractures, periprosthetic fractures and femoral non-unions. Some evidence suggests that the use of double plating of femoral fractures in polytraumatised patients may be beneficial over other types of fracture fixation. LEVEL OF EVIDENCE: IV.

A multi-institutional randomized controlled trial comparing first-generation transrectal high-resolution micro-ultrasound with conventional frequency transrectal ultrasound for prostate biopsy.

Objectives: To study high-frequency 29 MHz transrectal side-fire micro-ultrasound (micro-US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro-US imaging of the prostate. Materials and methods: A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro-US vs conventional end-fire ultrasound (conv-US) transrectal-guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro-US image interpretation protocol that was developed during the trial using data from the pre-training micro-US arm. Investigators received a standardized training program mid-trial, and the post-training micro-US data were used to examine the training effect. Results: Detection of csPCa (the primary outcome) was no better with the first-generation micro-US system than with conv-US in the overall population (34.6% vs 36.6%, respectively, P = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI-MUS in order to address the lack of understanding of the appearance of cancer under micro-US. Micro-US sensitivity in the post-training group improved to 60.8% from 24.6% (P < .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro-US arm increased by 7% after training (32% to 39%, P < .03), but training instituted mid-trial did not affect the overall results of the comparison between arms. Conclusion: Micro-US provided no clear benefit over conv-US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first-generation system.

[Baroreceptor activation therapy for therapy-resistant hypertension: indications and patient selection : Recommendations of the BAT consensus group 2017]. / Barorezeptorakivierungstherapie bei therapierefraktärer Hypertonie: Indikation und Patientenselektion : Empfehlungen der BAT-Konsensusgruppe 2017.

Baroreceptor activation therapy (BAT) has been available for several years for treatment of therapy-refractory hypertension (trHTN). This procedure is currently being carried out in a limited number of centers in Germany, also with the aim of offering a high level of expertise through sufficient experience; however, a growing number of patients who are treated with BAT experience problems that treating physicians are confronted with in routine medical practice. In order to address these problems, a consensus conference was held with experts in the field of trHTN in November 2016, which summarizes the current evidence and experience as well as the problem areas in handling BAT patients.

Trends in the use of partial nephrectomy for cT1 renal tumors: Analysis of a 10-yr European multicenter dataset.

AIM: Although extensively addressed in US registries, the utilization rate of Partial Nephrectomy has been poorly addressed in European settings. Our aim is to evaluate the impact of hospital volume on the use of PN for cT1 renal tumors. METHODS: 2526 patients with cT1N0M0 renal tumors treated with either PN or radical nephrectomy at 10 European centres in the last decade were included in the analysis. Joinpoint regression analysis was used to identify significant changes over time in linear slope of the trend for each center. The correlation between yearly caseload and the slopes was assessed with the non-parametric Spearman test. Coincident pairwise tests and regression analyses were used to generate and compare the trends of high-volume (HV), mid-volume (MV) and low-volume (LV) groups. RESULTS: Yearly caseload was significantly associated with increased use of PN (R = 0.69, p = 0.028). The utilization rate of PN was stable at LV centres (p = 0.67, p = 0.7, p = 0.76, for cT1, cT1a, and cT1b tumors, respectively), while increased significantly at MV (p = 0.002, 0.0005 and 0.007, respectively) and HV centers (all p < 0.0001). Regression analysis confirmed the trends for HV and MV as significantly different from those observed in LV centres (all p ≤ 0.002) and highlighted significant differences also between MV and HV centres (all p ≤ 0.03). CONCLUSIONS: We confirmed the association between caseload and the use of PN for cT1 tumors. Our findings suggest that a minimum caseload might turn the tide also in LV centres while a selective referral to HV centers for cT1b tumors should be considered.

Preoperative anemia is associated with adverse outcome in patients with urothelial carcinoma of the bladder following radical cystectomy.

PURPOSE: Radical cystectomy (RC) can be associated with significant blood loss, whereas many patients are presenting with anemia preoperatively. To date, there is a lack of data addressing the impact of preoperative anemia (PA) on survival of patients undergoing RC for urothelial carcinoma of the bladder (UCB). METHODS: This retrospective multicenter study includes 684 patients with UCB undergoing RC with pelvic lymph node dissection. The median follow-up was 50 (IQR 29,78) months. Anemia was defined in line with the WHO classification (hemoglobin (Hb): male ≤13 g/dL, female ≤12 g/dL) and based on contemporary gender- and age-adjusted classification (Hb: white male aged <60 years: ≤13.7 g/dL; ≥60 years: ≤13.2 g/dL; white female of all ages ≤12.2 g/dL). Univariable and multivariable Cox regression analyses were used to assess the effects of PA on oncological outcomes. RESULTS: A total of 269 (39.3 %) and 302 (44.2 %) patients were anemic according to the WHO classification versus contemporary classification. Age, increased ECOG performance status, advanced tumor stages, lymph node metastasis, positive surgical margin and anemia were associated with disease recurrence (DR), cancer-specific mortality (CSM) and all-cause mortality (ACM). In multivariable analysis, anemia was an independent predictor of DR, CSM and ACM (WHO and/or contemporary classification). Blood transfusion was significantly associated with ACM in both classifications of anemia. CONCLUSIONS: PA is significantly associated with worse oncological outcome in patients undergoing RC. Based on the additional unfavorable influence of blood transfusion, this emphasizes the importance of early diagnosis and correction of anemia and implementation of alternative methods of blood volume management.

Computed tomography after nephron-sparing surgery.

The increased use of abdominal cross-sectional imaging has contributed to a greater detection of incidental small renal masses. Treatment options for localized disease renal cell carcinoma include radical nephrectomy or partial nephrectomy (PN), the former being preferred for treatment of early-stage tumors. The most adopted technique for follow-up imaging is contrast-enhanced computed tomography (CT), whose findings can cause uncertainty and unnecessary repetition of examinations. Our purpose is to describe CT findings after PN and to describe evolution in time of such images.

Validation of RiskCheck Bladder Cancer ©, version 5.0 for risk-adapted screening of bladder cancer.

INTRODUCTION: The aim of the study was to assess the strength of the online tool RiskCheck Bladder Cancer©, version 5.0 (RCBC) for early detection of bladder cancer (BC). MATERIALS AND METHODS: RCBC was evaluated retrospectively based on the data of 241 patients, of which 141 were suffering from BC. Statistical analysis was performed by descriptive statistics, nonparametric group comparison, classification tree analysis and ROC analysis. RESULTS: ROC analysis of the risk classification showed a sensitivity of 71.6%, a specificity of 56.5%, a positive predictive value of 67.8%, a negative predictive value of 52% and an accuracy of 63.5%. BC risk factors ranked by importance are time of smoking (p < 0.0001), gender (within the nonsmoking group: p < 0.009), occupational toxin exposure (within the group <35 years of smoking: p < 0.048) and amount of consumed cigarettes resulting in a 95% association with BC (within the group >35 years of smoking: p < 0.0001). CONCLUSIONS: The high predictive power of RCBC for the identification of asymptomatic patients living under risk could be demonstrated.

Positive urine cytology and carcinoma in situ prior to second transurethral resection of the bladder correlate with positive second resection histology and the need for subsequent cystectomy.

OBJECTIVE: A second transurethral resection of the bladder (TURB) is recommended for high-grade bladder cancer (BC) yet yields negative results in over half of the cases. Aim of this study was to identify prognostic indicators of a positive second TURB or the need for a subsequent cystectomy. MATERIALS AND METHODS: The study cohort consisted of 101 patients with high-risk BC (T1G2-3, TaG3, Carcinoma in situ) who underwent second TURB after complete first resection. Age, gender, stage, grade, carcinoma in situ (Cis), tumour number, size, localization, surgeon experience and bladder wash cytology before the second TURB were considered as potential prognostic factors of positive histology at second TURB or the need for subsequent cystectomy. RESULTS: The mean follow-up period was 23.8 months. The study cohort was comprised of 82 males and 17 females. Cytology on bladder wash urine was performed in 85/101 patients and in 39 was negative; 55.5 % of second TURB specimens were negative. The rate of upstaging to ≥T2 was 4.9 %. Cis (OR 8.4; 95 % CI 1.3-54.2; p = 0.03) and positive cytology (OR 6.8; 95 % CI 2.3-19.9; p = <0.01) were independent prognostic factors of a residual tumour in the second TURB. Cytology also correlated with clinical need for cystectomy in the follow-up (HR 6.5; 95 % CI 1.3-30.5; p = 0.02). CONCLUSIONS: CIS and positive cytology prior to second TURB increased the risk of a positive second TURB specimen. A positive cytology also increases the risk of the subsequent need for cystectomy.

Nutritional status in the healthy longeval population from Sardinia (Italy).

OBJECTIVES: The aim of this study was to evaluate sex- and age-related variations of the nutritional status in the aged population of central Sardinia, a geographical area with a high frequency of long-lived people, particularly men. DESIGN: The sample consisted of 200 subjects over 70 years of age (men: N= 100, age= 81.0 +/- 7.0 years; women: N= 100, age= 81.5 +/- 7.3 years). SETTING: Orroli (central Sardinia, Italy). MEASUREMENTS: Mini nutritional assessment (MNA) and bioelectrical impedance vector analysis (BIVA) were used to evaluate nutritional status and body composition. RESULTS: The indicators revealed a generally good nutritional status. The MNA results (men: 24.6 +/- 2.2; women: 23.4 +/- 2.5) showed that 64.1% of the subjects had a normal nutritional status and only a small proportion (1.2%) could be classified as malnourished. BIVA showed that most subjects (74.2%) were normal, while the prevalence of low body cell mass was 10.7% and that of dehydration 11.2%. According to the MNA, the nutritional status was significantly better in the men. Almost three-quarters of the men (73.1%) were well nourished vs. half of the women (50.6%). A worsening of the nutritional status with age was observed. The proportion of malnourished individuals, as assessed by MNA, increased from 0% to 9.1% from 70-79 to > 90 years. CONCLUSIONS: With respect to their contemporaries from other regions, the elderly of Orroli presented a better nutritional status, a similar worsening with age and generally higher sexual dimorphism.

Multiprobe fluorescence in situ hybridisation: prognostic perspectives in superficial bladder cancer.

AIM: To establish independent prognostic factors on a chromosomal basis in superficial bladder cancer, using a multicolour fluorescence in situ hybridisation (FISH) probe mix. PATIENTS AND METHODS: In 2002, voided urine from 75 consecutive patients (mean age 71.7, range 52-93) years under follow-up for superficial urothelial cancer was studied prospectively. The patients were observed for a mean (standard deviation (SD)) period of 39.3 (6.8) months (range 27-58) until July 2005. A multicolour FISH on liquid-based voided urinary cytology was carried out on all patients. Univariate analysis, using a log rank test, was used to determine the prognostic relevance of a low-risk pattern and a high-risk pattern. Progression-free survival time was calculated from the date of first diagnosis to first recurrence or progression according to the Kaplan-Meier product-limit method. RESULTS: One patient was lost to follow-up. 27 of the 74 remaining (36.8%) patients showed recurrent disease. In 9 (33.3%) patients with a low-risk pattern disease recurred after a mean (SD) observation time of 29.7 (1.9) months (range 8.3-52.3, median 30.8 (12.4)). 18 (66.7%) patients with a high-risk pattern developed recurrence within a mean (SD) of 17.6 (2.0) months (range 4-38.8, median 16.7 (11.6)). The Kaplan-Meier curve for progression-free survival showed marked differences between the low-risk and the high-risk groups. CONCLUSION: Patients with a high-risk chromosomal pattern have a markedly shorter disease-free survival time and higher progression rate than patients with a low-risk pattern. High-risk patients can therefore be treated more aggressively to prevent tumour spreading.

Morbidity of laparoscopic extraperitoneal versus transperitoneal radical prostatectomy verus open retropubic radical prostatectomy.

OBJECTIVE: Morbidity and postoperative pain after extraperitoneal (E-LRPE) and transperitoneal (T-LRPE) laparoscopic radical prostatectomy was compared to open extraperitoneal radical prostatectomy (O-RPE). MATERIAL AND METHODS: Between January 2002 and October 2003, we evaluated 41 E-LRPE, 39 T-LRPE and 41 O-RPE prospectively. All operations were performed as standard procedures by the same group of surgeons and perioperative results and complications were evaluated. Pain management was performed with tramadol 50-100 mg on demand, and no other form of anaesthesia was given. Postoperative pain was assessed daily in all patients quantifying analgesic requirement and evaluation of Visual Analogue Scale (VAS). All patients had at least a 12 month follow-up. RESULTS: Mean age, prostate volume, PSA and Gleason score were comparable between all three groups (p>0.05). Mean blood loss was lower with laparoscopy (189+/-140 and 290+/-254 ml), as compared to 385+/-410 ml for O-RPE (p=0.002). However, mean operating times were significantly longer in L-TRPE (279+/-70 min) as compared to E-LRPE (217+/-51 min) and O-RPE (195+/-72 min) (p<0.001), but E-LRPE and O-RPE showed no statistical difference (p=0.1143). Average VAS score on the 1st and 5th postoperative day for E-LRPE versus T-LRPE versus O-RPE was 4.9+/-1.0 versus 7.8+/-1.5 versus 5.8+/-1.9 and 1.6+/-0.9 versus 2.3+/-1.2 versus 2.3+/-0.9 respectively, which was significant lower (p=0.02) between E-LRPE versus T-LRPE (p<0.001) and O-RPE (p=0.008), but equal (p=0.655) between T-LRPE and O-RPE since postoperative day 3. Mean tramadol analgesic consumption within the first postoperative week was 290 versus 490 versus 300 mg respectively, which was statistical different between E-LRPE and T-LRPE (p<0.001), O-RPE and T-LRPE (p<0.001), but not between E-LRPE and O-RPE (p=0.550). Statistical analysis revealed a strong correlation of urinary leakage with increased postoperative pain (p=0.029) in all groups, especially for T-LRPE (p=0.007). Likewise, increased operating times (>240 min) were associated with increased post-operative pain (p=0.049). Full continence defined as no pads at one year was achieved in 36/41 (88%, E-LRPE) versus 33/39 (85%, T-LRPE) versus 33/41 (81%, O-RPE), respectively (p=0.2). CONCLUSION: E-LRPE resulted in a significant subjective (VAS Score, p<0.001) and objective (analgetic consumption, p<0.001) pain reduction compared to T-LRPE, but only in VAS Score compared to O-RPE (p=0.008). Analgetic consumption during first postoperative week was equal in E-LRPE (290 mg) and O-RPE (300 mg) (p=0.550). Shorter operating times, lower urinary leakage rates, lower stricture rates and lower blood loss in E-LRPE compared to T-LRPE are mainly explained due to the long learning curve in LRPE, which we did not overcome yet, and not due to the approach (extraperitoneal versus transperitoneal).

Liquid-based cytology as a tool for the performance of uCyt+ and Urovysion Multicolour-FISH in the detection of urothelial carcinoma.

The aim of the study was to assess the value of liquid-based urinary cytology as a tool to perform uCyt+ and Multicolour-FISH in patients under follow-up after urothelial cancer. Therefore, standard cytology was compared to liquid-based cytology with the addition of the uCyt+ test, which traces the three monoclonal antibodies M344, LDQ10 and 19A211 in exfoliated urothelial cells; and Multicolour-FISH (including centromere-specific probes for chromosomes 3, 7, 17 and a locus-specific probe for 9p21/p16) performed on thin-layer specimens. UCyt+ showed an overall sensitivity of 86.2% and cytology of 45.0%. Overall sensitivity of both the tests combined was 90%. Sensitivity of Multicolour-FISH was 96.4%. All conventional cytology diagnoses were confirmed by liquid-based cytology. Liquid-based cytology is a valid tool for the performance of adjunctive analyses, such as uCyt+ and Multicolour-FISH, on residual cellular material.

Modified laparoscopic nephroureterectomy for treatment of upper urinary tract transitional cell cancer is not associated with an increased risk of tumour recurrence.

INTRODUCTION: Laparoscopic nephroureterectomy reduces the morbidity of surgical management of urinary tract transitional cell carcinoma (TCC), but a potentially increased risk for local tumour spreading was reported. We evaluated results obtained from patients undergoing a modified laparoscopic approach and open procedures in this respect. PATIENTS AND METHODS: Between January 2000 and March 2002 we performed 19 modified laparoscopic nephroureterectomies (LNU) with open intact specimen retrieval in conjunction with open distal ureter and bladder cuff removal and 15 open standard nephroureterectomies (ONU). Staging lymphadenectomy was performed in 14/19 (73.7%) patients with LNU and in 6/15 (40.0%) with ONU. In all patients operating time, blood loss, complications, pain score (VAS) and data in respect to tumour recurrence were analysed. Mean follow-up was 22.1+/-9.2 (range 14-34) months for LNU and 23.1+/-8.8 (14-36) for ONU respectively. RESULTS: In LNU and ONU pathological features were 12 pT1 vs. 10 pT1, 2 pT2 vs. 2 pT2 and 5 pT3 vs. 3 pT3, respectively. All patients had TCC and were R0 at final histology. Four patients with LNU had lymph node involvement, one in ONU. LNU had decreased operating times (p=0.057), blood loss (p=0.018), complications (p=0.001) and VAS scores (p=0.001). One tumour recurrence occurred in LNU, associated with a pT3b pN2 G3 TCC at final histology. One patient with ONU had local tumour recurrence at the site of the bladder cuff. No port-site metastasis occurred during follow-up with LNU. CONCLUSION: Improved peri-operative results and same cancer control as compared to open surgery by this modified LNU was not associated with an increased risk for tumour recurrence, since strict "non-touch" preparation, avoiding of urine spillage and intact specimen retrieval prevents tumour seeding. However, results from long term studies are still warranted to clarify this issue.

Stone treatment and coagulopathy.

OBJECTIVE: The aim of this retrospective study was to evaluate treatment protocols and results of upper tract stone treatment in patients with clotting disorders. METHODS: In a 6-year period, 6,827 stone interventions (ESWL or endourologic procedures) were performed in 5,739 patients. Thirty-five (0.61%) patients suffered from a variety of systemic clotting disorders or were anti-coagulated. Clotting disorders were corrected by specific therapy prior to any intervention. A total of 76 interventions were performed consisting of ESWL, ureteroscopy (URS), percutaneous nephrolithotomy (PNL), ureteric stenting or percutaneous nephrostomy. RESULTS: All patients became stone-free within 3 months or had clinically insignificant residual fragments. Severe complications were observed in 10/76 (13.1%) interventions. ESWL was successful in 88.9% (16/18) of patients, but associated with a 33.3% (6/18) complication rate; 27.8% (5/18) of patients required auxiliary procedures. URS and PNL were successful in all cases and complications occurred in 0% (0/7) and 33% (1/3) of patients, respectively. Time to complete stone clearance after ESWL was 32.0+/-49.3 days compared with a mean of 19.4+/-28.6 days in a non-coagulopathy control group; no difference was observed for endourologic procedures. Average costs of treatment in patients undergoing ureteroscopy was higher in patients with coagulopathy (4,611 versus 2,342); however, the difference was less pronounced compared with ESWL (6,070 versus 1,731). CONCLUSION: Patients with coagulopathy have a higher rate of complications despite apparently normal clotting parameters during treatment and hospitalisation was prolonged. The efficacy of ESWL was lower in patients with coagulopathy and we currently favour endoscopic procedures for stone removal in this patient group.

Urolithiasis in allograft kidneys.

OBJECTIVES: Allograft stones are an uncommon clinical problem and management is mainly based on anecdotal experience, rather than analysis of larger series. METHODS: In an 8-year period, 19 patients were treated for 19 renal and 3 ureteral stones. In 9 patients, stones were transplanted and 10 formed de novo stones within a mean of 28 months (range 13 to 48) after transplantation. In 4 patients, stones were removed during transplantation. Seven patients were treated with extracorporeal shock wave lithotripsy (ESWL), 3 patients had stones removed percutaneously, 1 by antegrade ureteroscopy, and 1 at the time of ureteral reimplantation. Three patients passed stones spontaneously. RESULTS: In 3 of 4 patients with stones detected before transplantation, the procedure was completed successfully after endoscopic stone removal. Three of 5 patients with transplanted stones required emergency nephrostomy; 1 patient had permanent renal impairment. Three (42.9%) of 7 patients treated with ESWL needed transient nephrostomy; ultimately, all became stone free within a mean 15 days (range 10 to 40). Endoscopic stone removal always resulted in complete clearance without renal impairment. All patients were stone free during a follow-up of 29 months (range 13 to 48). CONCLUSIONS: Nine (47%) of 19 stones were actually transplanted. Therefore, intraoperative screening by ultrasonography with subsequent endoscopic removal is advisable. Small stones (4 mm or less) may be closely followed up, because they can pass spontaneously. ESWL is the treatment of choice for caliceal stones sized 5 to 15 mm. However, for stones greater than 15 mm or for ureteral stones, antegrade endoscopic procedures seem to be more favorable.

Detection of upper urinary tract transitional cell carcinoma with ImmunoCyt: a preliminary report.

OBJECTIVES: To assess the clinical performance of ImmunoCyt in the detection of upper urinary tract transitional cell carcinoma (UT-TCC). This newly developed immunocytochemical test detects three cellular markers specific for TCC. METHODS: Thirty-seven patients with symptoms and/or findings on imaging suggestive of UT tumors were prospectively evaluated. All patients underwent a standard cytologic evaluation and ImmunoCyt testing of voided urine, as well as imaging studies. Urine samples were also obtained from the UT of 32 patients by ureteral catheterization and tested by cytologic analysis and ImmunoCyt. RESULTS: Sixteen patients had UT-TCC as documented by the final histologic evaluation. The sensitivity of testing the voided urine from 37 patients was 50% for cytologic analysis, 75% for ImmunoCyt, and 87% for both methods combined. The cytologic evaluation detected no G1, 1 (17%) of 6 G2, and 7 (100%) of 7 G3 tumors. ImmunoCyt detected 1 (33%) of 3 G1, 6 (100%) of 6 G2, and 5 (71%) of 7 G3 tumors. The sensitivity in the 32 urine samples obtained from the UT was 82% for cytologic analysis, 91% for ImmunoCyt, and 100% for both methods combined. Cytologic analysis detected all G2 and G3 (100% sensitivity) and no G1 tumors. ImmunoCyt detected 2 (100% sensitivity) of 2 G1, 4 (100%) of 4 G2, and 4 (80%) of 5 G3 tumors. The test specificity, calculated in 21 patients free of TCC, was 100% for cytologic analysis in voided and ureteral urine specimens and 95% and 100% for ImmunoCyt in voided and ureteral urine samples, respectively. CONCLUSIONS: The results of this preliminary study show that ImmunoCyt complements cytologic analysis in detecting UT-TCC, mainly because of its high sensitivity to low-grade TCC. The combination of cytologic testing and ImmunoCyt gives 100% sensitivity in detecting UT-TCC in UT urine samples.

Comparison of two qualitative assays, the UBC rapid test and the BTA stat test, in the diagnosis of urothelial cell carcinoma of the bladder.

OBJECTIVES: To compare the diagnostic value of two rapid tests, the bladder tumor antigen (BTA stat) test and the newly developed urinary bladder cancer (UBC) Rapid test, in patients having symptoms suggestive of urothelial cell carcinoma (UCC) and patients being followed up after transurethral resection. METHODS: One hundred eighty patients with a mean age of 65.8 years (range 22 to 92) were included in the present study. The tests were performed on voided urine samples. Fifty-seven patients had symptoms suggestive of UCC and 123 patients were being followed up after complete transurethral resection of UCC. The voided urine was evaluated by the BTA stat and UBC Rapid test, which detects cytokeratins 8 and 18. All patients underwent subsequent cystoscopic evaluation and biopsy of any suspicious lesion. RESULTS: In 53 patients with histologically proved UCC, the BTA stat had a sensitivity of 52.8% and the UBC Rapid test of 66%. According to the histologic stage, the sensitivity of the BTA stat was 42.8% in pTa tumors, 61.5% in pT1, and 70% in pT2 or higher tumors. The sensitivity of the UBC test was 60.7% in pTa, 69. 2% in pT1, and 80% in pT2 or higher tumors. For histologic grades 1 to 3, the sensitivity was 38.8%, 52.6%, and 68.7% for the BTA stat and 44.4%, 78.9%, and 75% for the UBC Rapid test, respectively. The specificity was 70% and 90% for the BTA stat and UBC Rapid test, respectively. CONCLUSIONS: The UBC Rapid test was superior to the BTA stat in both sensitivity and specificity. Both assays are simple office procedures and require no special knowledge. However, they cannot replace, but only lower, the number of cystoscopies during the follow-up of patients with previous UCC of the bladder.

Comparison of the monoclonal UBC-ELISA test and the NMP22 ELISA test for the detection of urothelial cell carcinoma of the bladder.

OBJECTIVES: To compare the diagnostic value of two enzyme-linked immunosorbent assay (ELISA) tests, the nuclear matrix protein 22 (NMP22) test and a newly developed urinary bladder cancer (UBC) test, in patients having symptoms suggestive of urothelial cell carcinoma (UCC) and patients under follow-up after transurethral resection (TUR). METHODS: Two hundred forty patients with a mean age of 65.8 years (range 22 to 92) were included in this retrospective study. The tests were performed on previously frozen urine samples. Eighty-one patients had symptoms suggestive of bladder cancer and 159 patients were being followed up after complete TUR of UCC. Voided urine was evaluated by the NMP22 test and the monoclonal UBC-ELISA test, which traces cytokeratins 8 and 18. All patients underwent subsequent cystoscopy and biopsy evaluation of any suspicious lesion. The cutoff levels for bladder cancer positivity were 10 U/mL for the NMP22 test and 12 microg/L for the UBC test. RESULTS: In the 54 patients with histologically proved UCC, the NMP22 test had a sensitivity of 55.5% and the UBC test a sensitivity of 64.8%. According to the histologic stages, the sensitivity of NMP22 was 51.7% in pTa tumors, 46.1% in pT1, and 70% in pT2 or higher tumors; the sensitivity of UBC was 62.1% in pTa, 53.8% in pT1, and 80% in pT2 or higher tumors. For histologic grades 1 to 3, the sensitivity was 50%, 50%, and 68.7% for NMP22 and 66.6%, 60%, and 68.7% for UBC, respectively. The specificity was 79% and 92% for NMP22 and UBC, respectively. CONCLUSIONS: The monoclonal UBC-ELISA test is superior to the NMP22 test in both sensitivity and specificity. Nevertheless, neither test can replace cystoscopy.

Immunocyt: a new tool for detecting transitional cell cancer of the urinary tract.

PURPOSE: The limitations of cytology and the invasiveness of cystoscopy for detecting bladder cancer generate increasing interest in noninvasive, urine bound diagnostic tools. We assessed the diagnostic value of the newly developed immunocytochemical test, Immunocyt, which detects cellular markers specific for transitional cell cancer in the voided urine of patients with bladder cancer. MATERIALS AND METHODS: Participating in our prospective study were 264 consecutive patients with a mean age of 65.9 years, including 114 in whom symptoms were suggestive of bladder cancer and 150 who were being followed after complete transurethral resection of superficial transitional cell carcinoma. Voided urine specimens were evaluated by standard cytology and the Immunocyt test, which traces the monoclonal antibodies M344, LDQ10 and 19A211 against transitional cell carcinoma in exfoliated urothelial cells. In all cases cystoscopy was subsequently performed and any suspicious lesion was evaluated by biopsy. RESULTS: Histologically proved transitional cell carcinoma was found in 79 patients. Immunocyt with cytology had 89.9% sensitivity overall (84, 88 and 96.5% in grades 1 to 3 disease, respectively). A total of 34 (43%), 3 (3.8%) and 34 (43%) cases were positive on Immunocyt only, cytology only and both evaluations, respectively. In 8 cases (10.1%) both tests were negative. Overall Immunocyt only was 86.1% sensitive (84, 84 and 89.6% in grades 1 to 3 disease, respectively) and 79.4% specific. Overall cytology only was 46.8% sensitive (4, 52 and 79.3% in grades 1 to 3 disease, respectively) and 98.2% specific. CONCLUSIONS: Immunocyt is a noninvasive, highly sensitive test for detecting transitional cell carcinoma of all grades and stages. When combined with conventional urinary cytology, it may replace cystoscopy in select patients, especially in followup protocols of low grade transitional cell carcinoma.