Value of early second session shock wave lithotripsy in treatment of upper ureteric stones compared to laser ureteroscopy.

PURPOSE: The safety and efficacy of early second session shock wave lithotripsy (SWL) compared with laser ureteroscopy (URS) for the treatment of upper ureteric stones were evaluated. METHODS: From January to October 2019, 108 patients with upper ureteric stones (< 1.5 cm and ≤ 1000 Hounsfield unit (HU)) were randomized into SWL and laser URS groups. The second SWL session was performed within 48-72 h of the first session. Using plain abdominal X-ray and ultrasonography, patients were evaluated 48-72 h after the first SWL session and one week after the second and third SWL sessions or one week after URS. The procedure was considered a success when no additional procedures were needed to clear the stone. To determine the stone-free rate (SFR), noncontrast computed tomography of the urinary tract was performed three months postoperatively. RESULTS: In the SWL group, the success rates were 92.6% and 94.4% after the second and third sessions. The SFR was 96.2% in the laser URS group. The success rates were not significantly different between the second and third SWL sessions versus the laser URS (p = 0.418 and 0.660, respectively). Operative and fluoroscopy times were significantly longer in the SWL group (p = 0.001), and JJ stent insertions were needed after laser URS. CONCLUSION: Ultraslow full-power SWL treatment of patients with upper ureteric stones (< 1.5 cm and ≤ 1000 HU) with an early second session is safe and effective compared to laser URS. Patients who do not respond to early second SWL session should be shifted to another treatment modality.

Ultraslow full-power shock wave lithotripsy protocol in the management of high attenuation value upper ureteric stones: A randomized comparative study.

OBJECTIVES: To evaluate the efficacy and safety of ultraslow full-power shock wave lithotripsy protocol in the management of high attenuation value upper ureteric stones compared with slow-rate, power-ramping shock wave lithotripsy. METHODS: This was a randomized trial enrolling patients with a single high attenuation value (≥1000 HU) upper ureteric stones between January 2019 and July 2019. Ultraslow full-power shock wave lithotripsy (54 patients) was applied at a rate of 30 shock waves/min with power ramping from 6 to 18 kV for 100 shock waves, then a safety pause for 2 min, followed by ramping 18-22 kV for 100 shock waves, then a safety pause for 2 min. Then, full power (22 kV) was maintained until the end of the session. Slow-rate, power-ramping shock wave lithotripsy (47 patients) was applied at a rate of 60 shock waves/min with power ramping from 6 to 10 kV during the first 500 shock waves, then from 11 to 22 kV during the next 1000 shock waves, then maintained on 22 kV in the last 1500 shock waves. Up to three sessions were carried out with a follow up 3 months after the last session. The primary outcome was the stone-free rate. Perioperative data of the two protocols were compared. RESULTS: There was no significant difference in preoperative data. The stone-free rate was significantly higher in ultraslow full-power shock wave lithotripsy after single (92.6% vs 23.4%) and multiple (96.3% vs 63.8%) sessions. Most complications were mild, with no significant difference between both groups (9.3% vs 12.8%; P = 0.573). Logistic regression analysis identified ultraslow full-power shock wave lithotripsy protocol as the only significant independent factor for the stone-free rate (odds ratio 12.589, P = 0.025). CONCLUSION: Ultraslow full-power shock wave lithotripsy for high attenuation value upper ureteric stones is associated with a significantly higher stone-free rate, and with mild complications that are comparable to those of standard shock wave lithotripsy.

Percutaneous nephrostomy versus JJ ureteric stent as the initial drainage method in kidney stone patients presenting with acute kidney injury: A prospective randomized study.

OBJECTIVE: To compare percutaneous nephrostomy tube versus JJ stent as an initial urinary drainage procedure in kidney stone patients presenting with acute kidney injury. METHODS: Between January 2017 and January 2019, 143 patients with acute kidney injury secondary to obstructive kidney stone were prospectively randomized into the percutaneous nephrostomy tube group (71 patients) and JJ stent group (72 patients) at Beni-Suef University Hospital, Beni-Suef, Egypt. Exclusion criteria included candidates for acute dialysis, fever (>38°C), pyonephrosis, pregnancy and uncontrolled coagulopathy. The period required for serum creatinine normalization, failure of insertion, operative and fluoroscopy time were recorded. Definitive stone management for proximal ureteral stones >1.5 cm consisted of percutaneous nephrolithotomy for the percutaneous nephrostomy group and ureteroscopic laser lithotripsy for the JJ stent group. For stone size <1.5 cm, ureteroscopy or shockwave lithotripsy was carried out for both groups. Percutaneous nephrolithotomy was carried out for renal stones >2 cm, and shockwave lithotripsy for stones <2 cm. Distal and mid ureteral stones were treated by ureteroscopy. RESULTS: The percutaneous nephrostomy group had shorter operative time (P = 0.001). There was no significant difference in the recovery period for normalization of serum creatinine between both groups (P = 0.120). Procedural failure, ureteric mucosal injury and perforations increased in the case of male sex, stone size >1.5 cm and upper ureteric stones in the JJ stent group. Procedural failure, pelvic perforations and intraoperative bleeding increased in case of male sex, mild hydronephrosis and stone size >2.5 cm in the percutaneous nephrostomy group. Suprapubic pain, urethral pain and lower urinary tract symptoms were significant in the JJ stent group. The presence of a JJ stent directed us toward ureteroscopy (P = 0.002) and the presence of a percutaneous nephrostomy directed us toward percutaneous nephrolithotomy (P = 0.001). CONCLUSIONS: Percutaneous nephrostomy facilitates subsequent percutaneous nephrolithotomy, especially when carried out by a urologist, and it has a higher insertion success rate, a shorter operative time and a lesser incidence of postoperative urinary tract infection than a JJ stent. A JJ stent facilitates subsequent ureteroscopy, but operative complications can increase in the case of proximal ureteral stones >1.5 cm.

Ultraslow full-power shock wave lithotripsy versus slow power-ramping shock wave lithotripsy in stones with high attenuation value: A randomized comparative study.

OBJECTIVES: To compare the efficacy and safety of ultraslow full-power versus slow rate, power-ramping shock wave lithotripsy in the management of stones with a high attenuation value. METHODS: This was a randomized comparative study enrolling patients with single high attenuation value (≥1000 Hounsfield unit) stones (≤3 cm) between September 2015 and May 2018. Patients with skin-to-stone distance >11 cm or body mass index >30 kg/m2 were excluded. Electrohydraulic shock wave lithotripsy was carried out at rate of 30 shock waves/min for group A versus 60 shock waves/min for group B. In group A, power ramping was from 6 to 18 kV for 100 shock waves, then a safety pause for 2 min, followed by ramping 18-22 kV for 100 shock waves, then a safety pause for 2 min. This full power (22 kV) was maintained until the end of the session. In group B, power ramping was carried out with an increase of 4 kV each 500 shock waves, then maintained on 22 kV in the last 1000-1500 shock waves. Follow up was carried out up to 3 months after the last session. Perioperative data were compared, including the stone free rate (as a primary outcome) and complications (secondary outcome). Predicting factors for success were analyzed using logistic regression. RESULTS: A total of 100 patients in group A and 96 patients in group B were included. The stone-free rate was significantly higher in group A (76% vs 38.5%; P < 0.001). Both groups were comparable in complication rates (20% vs 19.8%; P = 0.971). The stone-free rate remained significantly higher in group A in logistic regression analysis (odds ratio 24.011, 95% confidence interval 8.29-69.54; P < 0.001). CONCLUSIONS: Ultraslow full-power shock wave lithotripsy for high attenuation value stones is associated with an improved stone-free rate without affecting safety. Further validation studies are required using other shock wave lithotripsy machines.

Outcome of Botulinum Toxin-A intraprostatic injection for benign prostatic hyperplasia induced lower urinary tract symptoms: A prospective multicenter study.

INTRODUCTION: Our aim was to determine the factors predicting the outcome of intraprostatic injection of Botulinum Toxin-A (BTX-A) in the treatment of benign prostatic hyperplasia (BPH)-induced lower urinary tract symptoms (LUTS) and to evaluate its efficacy and safety. METHODS: Between September 2016 and May 2018, 45 Egyptian patients, with BPH-induced LUTS were included; the indication was a failure of medical treatment, unfit, or refusing surgical intervention. Measurements of prostate size by TRUS, total PSA level before and 12 weeks after injection. IPSS, uroflow, and postvoiding residual urine (PVR) were measured before injection, 2, 4, 8 and 12 weeks postinjection. 100 U BTX-A vial was diluted with 10 mL of saline then injected into the transition zone at base and midzone of the prostate by TRUS. RESULTS: The mean patients' age was 64.4 ± 6.6 years. Mean baseline IPSS 24.06 decreased to 18.75 at 2 weeks and progressively decreased to 16.37 at 12 weeks (P < 0.001), Q max of 9.08 mL/s. increased to 10.44 at 2 weeks and 11.44 at 12 weeks (P < 0.001), mean prostate volume was 67.44cc; decreased to 66.06cc (P < 0.001) at 12 weeks and mean residual urine was 82.62 mL and decreased to 57.66 mL at 12 weeks. DISCUSSION: Intraprostatic injection of BTX-A as modality treatment of LUTS/BPH significantly improve IPSS, Q max , PVR, and decrease prostate volume. We can suspect better results with this line of treatment in patients with IPSS ≤ 22 and Q max ≤ 10 mL/min and prostate volume ≤ 56.5cc.

PCA3-based nomogram for predicting prostate cancer and high grade cancer on initial transrectal guided biopsy.

BACKGROUND: To develop a validated prostate cancer antigen 3 (PCA3) based nomogram that predicts likelihood of overall prostate cancer (PCa) and intermediate/high grade prostate cancer (HGPCa) in men pursuing initial transrectal prostate biopsy (TRUS-PBx). METHODS: Data were collected on 3,675 men with serum prostate specific antigen level (PSA) ≤ 20 ng/ml who underwent initial prostate biopsy with at least 10 cores sampling at time of the biopsy. Two logistic regression models were constructed to predict overall PCa and HGPCa incorporating age, race, family history (FH) of PCa, PSA at diagnosis, PCA3, total prostate volume (TPV), and digital rectal exam (DRE). RESULTS: One thousand six hundred twenty (44%) patients had biopsy confirmed PCa with 701 men (19.1%) showing HGPCa. Statistically significant predictors of overall PCa were age (P < 0.0001, OR. 1.51), PSA at diagnosis (P < 0.0001, OR.1.95), PCA3 (P < 0.0001, OR.3.06), TPV (P < 0.0001, OR.0.47), FH (P = 0.003, OR.1.32), and abnormal DRE (P = 0.001, OR. 1.32). While for HGPCa, predictors were age (P < 0.0001, OR.1.77), PSA (P < 0.0001, OR.2.73), PCA3 (P < 0.0001, OR.2.26), TPV (P < 0.0001, OR.0.4), and DRE (P < 0.0001, OR.1.53). Two nomograms were reconstructed for predicted overall PCa probability at time of initial biopsy with a concordance index of 0.742 (Fig. 1), and HGPCa with a concordance index of 0.768 (Fig. 2). CONCLUSIONS: Our internally validated initial biopsy PCA3 based nomogram is reconstructed based on a large dataset. The c-index indicates high predictive accuracy, especially for high grade PCa and improves the ability to predict biopsy outcomes.

Low risk patients benefit from extreme anterior apical sampling on initial biopsy for prostate cancer diagnosis.

BACKGROUND: To assess the effect of additional extreme apical sampling on prostate cancer (PCa) detection and aggressiveness in patients with standard risk versus high risk of a positive biopsy. METHODS: Three thousand fifty three men were reviewed from our institution review board approved prostate biopsy database. Two thousand five hundred and twenty one underwent biopsy with 12 cores while 532 underwent 14 core sampling (2 extra cores from the extreme anterior apex). Patients were stratified into one of two risk groups: (1) standard risk of PCa (elevated prostate specific antigen (PSA) < 10 ng/ml, normal digital rectal exam (DRE), and no lesions on transrectal ultrasound (TRUS)), and (2) higher risk of PCa (PSA > 10 ng/ml and/or abnormal DRE and/or lesion on TRUS). Prostate cancer detection and disease characteristics were compared between the biopsy schemes stratified by risk of a positive biopsy. RESULTS: PCa detection with 14 core sampling was more likely in all patients (OR 1.339, 95% CL 1.070-1.676) and in men with standard risk (OR 1.334, 95% CL 1.007-1.769). A greater median number of positive cores (3 vs. 2) and a higher maximum cancer % per core (40% vs. 25%) were seen in the 14 core cohort when stratified to standard risk. Gleason ≥7 was more likely detected with 14 cores in the standard risk group (55.6% vs. 45.2%). Differences in PCa detection and Gleason ≥7 between biopsy techniques were not noted in the higher risk group. CONCLUSION: Extreme apical sampling increases aggressive cancer detection on initial biopsy, especially in patients with standard risk of PCa.

Global prevalence of depression in chronic kidney disease: a systematic review and meta-analysis.

BACKGROUND: Chronic kidney disease (CKD) is commonly associated with psychosocial problems, especially depression, contributing to poor overall outcomes. Depression has not been given adequate priority in the management of CKD patients despite its significant adverse impact on all major outcomes. This systematic review and meta-analysis determined the pooled prevalence of clinical depression in the global CKD population and sub-populations. METHODS: PubMed, African Journals Online (AJOL), and EMBASE were systematically searched to identify published articles with relevant data. The pooled prevalence of clinical depression in the global CKD population was determined using random effects meta-analytic techniques. The study protocol was registered with PROSPERO (CRD42022382708). RESULTS: Sixty-five articles were included in this review, comprising 80,932 individuals with CKD from 27 countries. The participants' mean age ranged from 11.0 to 76.3 years. Most (70.4%) of the studies had medium methodological quality. The overall pooled prevalence of depression was 26.5% (95% CI 23.1-30.1%). Studies using the Diagnostic Statistical Manual for Mental Diseases (DSM) and International Classification of Disease (ICD) returned a pooled prevalence of 25.5% and 39.6%, respectively, p = 0.03. There was a significant difference in the pooled prevalence across regions; p = 0.002.The prevalence of depression was higher among individuals on chronic hemodialysis compared to pre-dialysis patients (29.9% versus 18.5%; p = 0.01) and among those on hemodialysis compared to peritoneal dialysis (30.6% versus 20.4%; p = 0.04). There was no significant difference between adults and children (26.8% versus 15.9%, p = 0.21). There was an increasing temporal trend in depression prevalence, though this did not achieve statistical significance (p = 0.16). CONCLUSION: Depression is common in patients with CKD. The findings of this study highlight the need for clinicians to make efforts to evaluate individuals with CKD for depression, especially those with advanced stages of the disease.

The prevalence and risk of mortality associated with intradialytic hypertension among patients with end-stage kidney disease on haemodialysis: A systematic review and meta-analysis.

INTRODUCTION: Intradialytic hypertension (IDHTN) is a common but less frequently recognised complication of haemodialysis. However, it is associated with increased overall mortality in patients on haemodialysis. This systematic review and meta-analysis aimed to determine the prevalence of IDHTN and associated mortality risk in the global haemodialysis population. METHOD: A systematic search of PubMed and EMBASE was undertaken to identify articles with relevant data published between 1990 and 2023. The pooled prevalence of IDHTN in the global haemodialysis population was determined using the DerSimonian-Laird random-effects meta-analysis. The pooled hazards ratio for mortality in patients with IDHTN was also computed from the studies that reported mortality among haemodialysis patients with IDHTN. The study protocol was registered with PROSPERO (CRD42023388278). RESULTS: Thirty-two articles from 17 countries were included, with a pooled population of 127,080 hemodialysis patients (median age 55.1 years, 38.2% females). Most studies had medium methodological quality (53.1%, n = 17). The overall pooled prevalence of IDHTN was 26.6% [(95% CI 20.2-33.4%), n = 27 studies, I2 = 99.3%, p<0.001 for heterogeneity], with significant differences depending on the definition used. The pooled proportion of haemodialysis sessions with IDHTN was 19.9% [(95% 12.5-28.6%, n = 8 studies, I2 = 99.3%, p<0.001 for heterogeneity)] with significant differences across the different definition criteria. The p-value for the Begg test was 0.85. The median pre-dialysis blood pressure was not significantly associated with IDHTN. The pooled hazard ratio for mortality was 1.37 (95% CI 1.09-1.65), n = 5 studies, I2 = 13.7%, and p-value for heterogeneity = 0.33. CONCLUSION: The prevalence of IDHTN is high and varies widely according to the definition used. A consensus definition of IDHTN is needed to promote uniformity in research and management. The increased mortality risk forecasted by IDHTN highlights the need for optimal blood pressure control in patients on hemodialysis.

The utility of PSA velocity in prediction of prostate cancer and high grade cancer after an initially negative prostate biopsy.

BACKGROUND: Prostate specific antigen kinetics (PSAK) including prostate specific antigen velocity (PSAV) and PSA doubling time (PSADT) are used as predictors of prostate cancer (PCa) therapeutic outcome, disease prognosis, and cancer-specific mortality. However controversy persists regarding use of these parameters in cancer detection. Our aim is to evaluate PSAV as a predictor of PCa and intermediate/high grade PCa (HGPCa). METHODS: We included 682 patients that underwent repeat transrectal ultrasound guided biopsy after initial negative biopsy. Univariate and multivariate analyses as well as area under the receiver operating characteristic curve (ROC-AUC) were performed to assess predictive accuracy regarding detection of PCa and intermediate/HGPCa (Gleason score ≥ 7). RESULTS: PCa was detected in 179/682 (26.24%) patients. Our univariate analysis suggested that age, total prostate volume (TPV), atypical small acinar proliferation (ASAP) and PSA indices in the form of PSA at the time of repeat biopsy (PSA2), PSAV, PSA density (PSAD2) and percent free PSA at time of repeat biopsy (%FPSA2) were all predictors of overall PCa and intermediate/HGPCa. Meanwhile, our multivariate model showed that factors associated with overall PCa and intermediate/HGPCa were age, PSAV and TPV. CONCLUSIONS: In men pursuing a second biopsy after an initial negative biopsy, PSAV was an independent predictor of overall PCa, intermediate and high grade cancer.

Identification of the variables associated with pain during transrectal ultrasonography-guided prostate biopsy in the era of periprostatic nerve block: the role of transrectal probe configuration.

OBJECTIVE: To identify the different factors that are associated with pain perceived during transrectal ultrasonography (TRUS)-guided prostate biopsy (PBx), with special focus on the role of transrectal probe configuration. PATIENTS AND METHODS: We analysed prospective data on 1114 patients undergoing TRUS-guided PBx at our institute from January 2007 to August 2010. Patients completed questionnaires based on a 10-point visual analogue pain scale related to the consecutive steps of PBx: probe insertion, application of periprostatic nerve block (PPNB) and the obtaining of PBx cores. The variables of interest were age, prostate volume, DRE findings, number of previous biopsies, probe type and the number of retrieved cores. All variables were correlated to pain scores using multivariate regression analysis. RESULTS: At the probe insertion step, end-fire probes were more painful than side-fire probes. The Siemens G50 with metal, short plastic and long plastic needle guides (Siemens, Munich, Germany) had higher pain scores than the B&K probe (Bruel & Kjaer Medical, Copenhagen, Denmark; P = 0.09, 0.008 and 0.003, respectively). For pain at the PPNB application step, all G50(TM) guide subtypes and the Sonoline Prima probe (Siemens) had higher pain scores than the B&K probe, but this only reached statistical significance for the G50(TM) probe with short plastic guide (P = 0.03). On obtaining PBx cores, all G50(TM) subtypes had higher pain scores when compared with the B&K probe (P = 0.59, 0.38 and 0.69, respectively). CONCLUSIONS: The probe design and needle guide affect pain during each step of TRUS-guided PBx. Both the B&K and Sonoline Prima probes caused less pain when compared with the G50(TM) probe, regardless of needle guide.

Translational and linguistic validation of the Arabic version of dysfunctional voiding symptom score questionnaire.

INTRODUCTION: Dysfunctional voiding is a multifactorial condition that encompasses a wide variety of symptoms rendering its diagnosis a challenging process. In this setting, several tools have been proposed to aid the diagnosis of this disease among which is the Dysfunctional Voiding Symptom Score (DVSS). The DVSS has been translated and validated to different languages including Japanese, Thai, Chinese, Serbian, and Portuguese. The aim of the current study is to translate and cross-culturally validate the DVSS into the Arabic language. MATERIAL AND METHODS: The DVSS was translated and culturally adapted to the Arabic language following the standards of the ISPOR for the translation and cultural adaptation process for patient-reported outcomes measures. Subsequently, the translated version underwent a pre-test on 15 patients with dysfunctional voiding. Afterwards, the translated version was filled by 82 pediatric patients and/or their parents with dysfunctional voiding and then the same questionnaire was refilled by the patients and their families one week later at home. Finally, a group of healthy children and/or their parents were recruited to fill the questionnaire as a control group. Cronbach's alpha, Pearson's correlation, and Interclass correlation were used to assess for internal consistency and reliability between test-retest of the Arabic version. RESULTS: The mean total score of DVSS for the case and control groups was 16.66 ± 6.07 and 6.11 ± 3.36, respectively (P < 0.001). The Arabic-DVSS showed excellent internal consistency (Cronbach's α > 0.9) for all the questions except Q1, Q3, Q6, and Q7 that showed good internal consistency. DISCUSSION: Translational and linguistic validation of the DVSS questionnaire into Arabic language is an important step toward its introduction in the clinical practice in Arabic countries; however, this step has also to consider the cultural variations between countries and not just linguistic translation. Generally, the Arabic-DVSS showed a satisfactory test-retest internal consistency and reliability with an excellent Cronbach's α (0.982) and ICC (0.962) for the total score of the Arabic-DVSS. Yet, the main limitation of this study was that it was only advocated for the translation and validation of the Arabic-DVSS and did not assess its value in patients' follow-up. CONCLUSION: The Arabic version of the DVSS is reliable and valid to help in the evaluation of DV in children of Arabic countries.

Type of transrectal ultrasonography probe influences prostate cancer detection rates on repeat prostate biopsy.

UNLABELLED: It is known that the end-fire probe detects more prostate cancer on initial prostate biopsy, but there is no literature looking at the influence of type of probe on repeat biopsy. Given that the literature on the influence of ultrasonography probe on repeat prostate biopsy is non-existent, the present study adds information which may help urologists improve their chances of detecting prostate cancer on prostate biopsy. Determining which type of probe to use on a prostate biopsy is a simple external factor that may help improve patient management. OBJECTIVE: To determine if the type of transrectal ultrasonography (TRUS) probe used during repeat prostate biopsy influences prostate cancer detection rates. PATIENTS AND METHODS: We conducted a retrospective chart review of 680 men undergoing repeat prostate biopsy at our institution between 2000 and 2010. Patient mean (range) age was 64.2 (39-95) years. The median (range) prostate-specific antigen (PSA) level was 5.5 (0.37-33.8) ng/mL and median (range) free PSA was 17 (5-45) %. Patient age, PSA, prostate volume, number of biopsy cores, time interval between initial and repeat biopsy, digital rectal examination and pathological findings were all included in a multivariate logistic regression analysis. RESULTS: The use of an end-fire probe on repeat biopsy significantly increased prostate cancer detection (odds ratio [OR] 1.59, 95% confidence interval [CI]: 1.03-2.46). The time interval between 1(st) and 2(nd) biopsy was also significant (OR 1.46, 95% CI: 1.11-1.09). On univariate analysis, white race (OR 0.66, 95% CI: 0.44-0.99), increasing prostate volume (OR 0.70, 95% CI: 0.55-0.89), and higher free PSA (OR 0.54, 95% CI: 0.34-0.84) were associated with a decreased risk of cancer. When evaluating the different permutations of using an end-fire or side-fire probe on initial or repeat biopsy, there was no difference in prostate cancer detection regardless of order of use of an end-fire or side-fire probe. CONCLUSIONS: An end-fire probe is associated with improved prostate cancer detection rates on both initial and repeat biopsy. The order of probe use does not appear to matter.

Hospitalization patterns in HD patients in the Kingdom of Saudi Arabia: A comprehensive cohort study.

INTRODUCTION: The rate of hospitalization represents a morbidity indicator in HD patients. The study aimed to evaluate hospitalization patterns in a large HD cohort. METHODS: All DaVita-KSA HD patients from October 2014 to December 2019 were included. Demographical and clinical characteristics and hospitalization data were recorded. Less than 24 h admission was excluded. Overall and cause-specific hospitalization rates were calculated. RESULTS: During the follow-up period, 3982 patients with a mean age of 52.5 ± 16.8 years, 2667 hospitalizations were recorded in 34.1% of the patients and 45.6% had repeated admissions. Infectious causes accounted for 26.6% of all recorded causes vs. 15.6% for cardiovascular complications. The median hospital stay length was 11 days, while the overall annual hospitalization rate of 34.9% and the annual duration of 3.7 days per patient. Hospitalized patients had a higher risk of mortality (p < 0.001). CONCLUSION: Infectious complications were the leading cause of hospitalization and had the longest hospital stay.

Creation and validation of the harmonized Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).

Objectives: Tocreate and validate a translated Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), a validated patient-reported outcome (PRO) widely used for assessing the quality of life in patients with prostate cancer (PCa). Patients and Methods: Using the established protocol as defined by the Professional Society for the Health Economics and Outcomes Research (ISPOR) for translating patient care questionnaires, a harmonised translated Arabic version of EPIC-CP was created. The questionnaire was tested in native Arabic speakers from four different Arabic countries (Saudi Arabia, United Arab Emirates, Jordan, and Kuwait). Cronbach's alpha and interclass coefficient correlation (ICC) analyses were used to test the internal consistency and test-retest reliability, respectively. In addition, PCa characteristics were collected for participants. Results: In total, 168 patients with PCa participated in the study (39 from Saudi Arabia, 23 from United Arab Emirates, 65 from Jordan, and 41 from Kuwait). In all, 52 (31%) participants repeated the questionnaire for test-retest reliability analysis. The median (interquartile range [IQR]) age of patients included in the study was 66 (61-71) years. The median (IQR) PSA level was 9.8 (6-19) ng/mL. Most patients had Grade Group 2 PCa at diagnosis (31%), clinical stage cT1 (42%), managed primarily by urology (79%), and the primary treatment was radical prostatectomy (71%). The total Cronbach's alpha coefficient was 0.84 demonstrating an acceptable internal consistency. The total ICC was also acceptable at 0.64. Conclusion: The Arabic version of the EPIC-CP is a reliable and valid tool for assessing health-related quality of life for Arabic patients with PCa.

Statin use and risk of prostate cancer in a population of men who underwent biopsy.

PURPOSE: We determined the association between statin use and prostate cancer in men who underwent prostate biopsy. MATERIALS AND METHODS: We performed a retrospective cohort study of men who underwent prostate biopsy from 2000 to 2007 at Cleveland Clinic. Statin use was determined using outpatient pharmacy records, and clinical and pathological outcomes were obtained. Multivariate logistic regression analysis to determine the effects of statins (and duration of use) was performed after adjusting for age, body mass index, African-American race, number of cores taken and prostate volume. RESULTS: We analyzed data from 4,204 patients, and we identified 3,182 (75.7%) not on statins and 1,022 on statins. Men diagnosed with prostate cancer on statins compared to those not taking statins were less likely to have digital rectal examination positivity (5.3% vs 8.9%, OR 0.7, p <0.01), Gleason score 7 or greater prostate cancer (61.4% vs 72.4%, OR 0.78, p = 0.02) and high volume prostate cancer (27.2 vs 31.4, p <0.01). Moreover statin users had lower prostate specific antigen compared to nonstatin users (5.13 vs 5.98, p = 0.03). Multivariate analysis adjusted risk ratios for prostate cancer diagnosis, high grade prostate cancer (Gleason score 7 or greater) and 3 or more cores positive in statin users were 0.92 (95% CI 0.85-0.98), 0.76 (95% CI 0.67-0.85) and 0.86 (95% CI 0.75-0.97) and only high grade prostate cancer persisted with length of use. CONCLUSIONS: Statin use was associated with a decreased risk of prostate cancer, less frequent high grade prostate cancer and lower volume of prostate cancer, suggesting that statin use has a protective effect against prostate cancer.

Office based transrectal saturation biopsy improves prostate cancer detection compared to extended biopsy in the repeat biopsy population.

PURPOSE: Multiple studies have shown significant prostate cancer detection for repeat biopsy. However, the best approach regarding core number and location remains controversial. Transrectal saturation biopsy is believed to increase cancer detection but to our knowledge no studies comparing it to 12 to 14-core extended biopsy have been published. We compared saturation and extended repeat biopsy protocols after initially negative biopsy. MATERIALS AND METHODS: A total of 1,056 men underwent prostate biopsy after initially negative biopsy. The extended biopsy group included 393 men with 12 to 14-core repeat biopsy. The saturation biopsy group included 663 men with 20 to 24-core repeat biopsy. We analyzed demographics and prostate cancer between the 2 groups. We compared prostate cancer detection in patients with previous atypical small acinar proliferation and/or high grade prostatic intraepithelial neoplasia as well as the risk of detecting clinically insignificant tumors. RESULTS: Prostate cancer was detected in 315 of the 1,056 patients (29.8%). Saturation biopsy detected almost a third more cancers (32.7% vs 24.9%, p=0.0075). In patients with a benign initial biopsy saturation biopsy achieved significantly greater prostate cancer detection (33.3% vs 25.6%, p=0.027). For previous atypical small acinar proliferation and/or high grade prostatic intraepithelial neoplasia there was a trend toward higher prostate cancer detection rate in the saturation group but it did not attain statistical significance (31.2% vs 23.3%, p=0.13). Of 315 positive biopsies 119 (37.8%) revealed clinically insignificant cancer (40.1% vs 32.6%, p=0.2). CONCLUSIONS: Compared to extended biopsy, office based saturation biopsy significantly increases cancer detection on repeat biopsy. The potential for increased detection of clinically insignificant cancer should be weighed against missing significant cases.

Performance of prostate cancer prevention trial risk calculator in a contemporary cohort screened for prostate cancer and diagnosed by extended prostate biopsy.

PURPOSE: Statistical models such as the Prostate Cancer Prevention Trial risk calculator have been developed to estimate the cancer risk in an individual and help determine indications for biopsy. We assessed risk calculator performance in a large contemporary cohort of patients sampled by extended biopsy schemes. MATERIALS AND METHODS: The validation cohort comprised 3,482 men who underwent a total of 4,515 prostate biopsies. Calculator performance was evaluated by ROC AUC and calibration plots. A multivariate regression model was fitted to address important predictor variables in the validation data set. Prediction error was calculated as the response variable in another multivariate regression model. RESULTS: Using an average of 13 cores per biopsy prostate cancer was detected in 1,862 patients. The calculator showed an AUC of 0.57 to predict all cancers and 0.60 for high grade cancer. Multivariate analysis of the predictive ability of various clinical factors revealed that race and the number of biopsy cores did not predict overall or high grade cancer at biopsy. Prior negative biopsy, patient age and free prostate specific antigen were significantly associated with prediction error for overall and high grade cancer. Race and family history had a significant association with prediction error only for high grade disease. CONCLUSIONS: To our knowledge our external validation of the Prostate Cancer Prevention Trial risk calculator was done in the largest cohort of men screened for prostate cancer to date. Results suggest that the current calculator remains predictive but does not maintain initial accuracy in contemporary patients sampled by more extensive biopsy schemes. Data suggest that the predictive ability of the calculator in current clinical practice may be improved by modeling contemporary data and/or incorporating additional prognostic variables.

Multifocal high grade prostatic intraepithelial neoplasia is a risk factor for subsequent prostate cancer.

PURPOSE: The risk of under diagnosed or development of subsequent prostate cancer and the treatment of patients diagnosed with high grade prostatic intraepithelial neoplasia remain controversial. We evaluated the relationship between high grade prostatic intraepithelial neoplasia on initial biopsy and the future presence of prostate cancer. MATERIALS AND METHODS: From December 1997 to February 2008 a total of 328 men underwent a second prostate biopsy after being initially diagnosed with high grade prostatic intraepithelial neoplasia. Men with prostate cancer or atypia on initial biopsy were excluded from study. Another 335 men without high grade prostatic intraepithelial neoplasia, prostate cancer or atypia underwent a second prostate biopsy based on clinical suspicion alone. A Cox proportional hazards model was used to estimate the effect of high grade prostatic intraepithelial neoplasia on the subsequent diagnosis of prostate cancer after adjustment for prostate specific antigen, age, presence of inflammation, abnormal digital rectal examination and number of cores obtained at biopsy. High grade prostatic intraepithelial neoplasia was also stratified into multifocal disease and laterality. Adjusted Kaplan-Meier plots were generated to estimate the rates of prostate cancer. RESULTS: High grade prostatic intraepithelial neoplasia alone on initial prostate biopsy had a significant effect on the subsequent diagnosis of prostate cancer (HR 1.89; 95% CI 1.39, 2.55; p <0.0001). Stratifying high grade prostatic intraepithelial neoplasia into multifocal and bilateral disease significantly increased the hazard ratios to 2.56 (95% CI 1.83, 3.60) and 2.20 (95% CI 1.51, 3.21), respectively, resulting in estimated 3-year cancer rates of 29.0% and 37.0% compared to 12.5% and 18.9%, respectively, following benign biopsy. CONCLUSIONS: Multifocal and bilateral disease are adverse features of high grade prostatic intraepithelial neoplasia that significantly increase the risk of prostate cancer despite adjusting for other clinical indicators such as prostate specific antigen and abnormal digital rectal examination.

Development and validation of a nomogram for predicting a positive repeat prostate biopsy in patients with a previous negative biopsy session in the era of extended prostate sampling.

OBJECTIVE: To create a nomogram for predicting the probability of a positive biopsy in men with one or more previous negative biopsies, as the false-negative rate of prostate biopsy in contemporary series remains substantial, and there is a need to identify those with a negative result but with a high risk of having unrecognized prostate cancer. PATIENTS AND METHODS: The study included 408 patients from Cleveland Clinic who had one or more repeat biopsies after an initial negative biopsy from 1999 to 2008. Another 470 men with the same criteria were used to validate the nomogram. Nomogram variables included age, family history of prostate cancer, body mass index, findings on a digital rectal examination, prostate-specific antigen (PSA) level, PSA slope, total prostate volume, months from initial negative biopsy session, months from previous negative biopsy, cumulative number of negative cores previously taken and history of high-grade intraepithelial neoplasia or atypical small acinar proliferation. We calculated the nomogram predicted probability in each patient. These predicted outcomes were compared with the actual biopsy results. The area under the receiver operating characteristic (ROC) curve was calculated as a measure of discrimination. RESULTS: The mean number of previous negative biopsies was 1.5, and the mean number of cores per session was 19.1. Of the original development data, 129 men (31.6%) had prostate cancer. A nomogram was constructed that had a concordance index of 0.72, which was greater than any single risk factor. In the validation group the area under the ROC curve was 0.62. CONCLUSIONS: Our nomogram for predicting a positive repeat biopsy can provide important additional information to aid the urologist and patient with a negative biopsy in evaluating clinical options.