Canadian Experience with the Adjustable Transobturator Male System for Post-Prostatectomy Incontinence: A Multicenter Study.

PURPOSE: We assessed the efficacy and safety profile of the ATOMS® (Adjustable Transobturator Male System) for post-prostatectomy incontinence in a multicenter North American setting. MATERIALS AND METHODS: We reviewed outcomes from 8 centers in men who underwent treatment of post-prostatectomy incontinence with an ATOMS. Primary study outcomes were pad changes and continence, defined as requiring 1.0 or 0 pad postoperatively in patients who required 2.0 or more pads preoperatively and 0 pad in those who required more than 1.0 or 2.0 pads preoperatively. Secondary outcomes included improvement, 90-day complications and patient satisfaction. RESULTS: A total of 160 patients were enrolled in study with a median followup of 9.0 months. Preoperative median pad use was 4 per day (IQR 3-5). Of the patients 36.3% reported severe preoperative incontinence, 31.3% received prior radiotherapy and 16.3% underwent previous incontinence surgery. Median postoperative pad use after adjustments was 0.5 per day (IQR 0-1, p <0.001). The overall continence rate was 80.0% with improvement in 87.8% of cases. Of the patients 70.1% underwent a mean ± SD of 2.4 ± 2.7 adjustments (IQR 0-16). The patient satisfaction rate was 86.3%, 22.3% experienced 90-day complications of any grade and 7 (4.4%) experienced Clavien III complications primarily related to the injection port. Patients with a history of radiotherapy were less likely to be continent (62.5% vs 87.9%, p=0.002), improved (77.1% vs 92.6%, p=0.02) or satisfied (69.8% vs 93.2%, p=0.001). Similarly patients with previous incontinence surgery had lower rates of continence, improvement and satisfaction (57.7%, 73.1% and 69.6%, respectively). CONCLUSIONS: In the short term the ATOMS is a safe and efficacious device to treat post-prostatectomy incontinence. Patients with concurrent radiotherapy and previous incontinence surgery respond to treatment but are less likely to be continent, improved or satisfied.

Update of the ICUD-SIU consultation on stone technology behind ureteroscopy.

INTRODUCTION: Ureteroscopy is now the most frequent treatment used around the world for stone disease. Technological advancement, efficiency, safety, and minimally invasiveness of this procedure are some of the reasons for this change of trend. MATERIALS AND METHODS: In this review of the literature, a search of the PubMed database was conducted to identify articles related to ureteroscopy and accessories. The committee assigned by the International Consultation on Urological Disease reviewed all the data and produced a consensus statement relating to the ureteroscopy and all the particularities around this procedure. CONCLUSION: This manuscript provides literatures and recommendations for endourologists to keep them informed in regard to the preoperative, intraoperative, and postoperative consideration in regard of a ureteroscopy.

The Clinical Research Office of the Endourological Society (CROES) Multicentre Randomised Trial of Narrow Band Imaging-Assisted Transurethral Resection of Bladder Tumour (TURBT) Versus Conventional White Light Imaging-Assisted TURBT in Primary Non-Muscle-invasive Bladder Cancer Patients: Trial Protocol and 1-year Results.

BACKGROUND: White light (WL) is the established imaging modality for transurethral resection of bladder tumour (TURBT). Narrow band imaging (NBI) is a promising addition. OBJECTIVES: To compare 12-mo recurrence rates following TURBT using NBI versus WL guidance. DESIGN, SETTING, AND PARTICIPANTS: The Clinical Research Office of the Endourological Society (CROES) conducted a prospective randomised single-blind multicentre study. Patients with primary non-muscle-invasive bladder cancer (NMIBC) were randomly assigned 1:1 to TURBT guided by NBI or WL. INTERVENTION: TURBT for NMIBC using NBI or WL. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Twelve-month recurrence rates were compared by chi-square tests and survival analyses. RESULTS AND LIMITATIONS: Of the 965 patients enrolled in the study, 481 patients underwent WL-assisted TURBT and 484 patients received NBI-assisted TURBT. Of these, 294 and 303 patients, respectively, completed 12-mo follow-up, with recurrence rates of 27.1% and 25.4%, respectively (p=0.585, intention-to-treat [ITT] analysis). In patients at low risk for disease recurrence, recurrence rates at 12 mo were significantly higher in the WL group compared with the NBI group (27.3% vs 5.6%; p=0.002, ITT analysis). Although TURBT took longer on average with NBI plus WL compared with WL alone (38.1 vs 35.0min, p=0.039, ITT; 39.1 vs 35.7min, p=0.047, per protocol [PP] analysis), lesions were significantly more often visible with NBI than with WL (p=0.033). Frequency and severity of adverse events were similar in both treatment groups. Possible limitations were lack of uniformity of surgical resection, data on smoking status, central pathology review, and specific data regarding adjuvant intravesical instillation therapy. CONCLUSIONS: NBI and WL guidance achieved similar overall recurrence rates 12 mo after TURBT in patients with NMIBC. NBI-assisted TURBT significantly reduced the likelihood of disease recurrence in low-risk patients. PATIENT SUMMARY: Use of a narrow band imaging technique might provide greater detection of bladder tumours and subsequent treatment leading to reduced recurrence in low-risk patients.

Perceived effects of the 16-hour workday restriction on surgical specialties: Quebec's experience.

OBJECTIVE: Quebec was the first Canadian province to implement a 16-hour workday restriction. Our aim was to assess and compare Quebec's surgical residents' and professors' perception regarding the effects on the educational environment, quality of care, and quality of life. DESIGN: The Surgical Theater Educational Environment Measure, the Postgraduate Hospital Educational Environment Measure, quality of the medical act, and quality-of-life questionnaires were administered 6 months after the work-hour restrictions. SETTING: Université de Montréal Surgery Department, Montréal, Québec, Canada; Université de Sherbrooke Surgery Department, Sherbrooke, Québec, Canada; Université Laval Surgery Department, Québec, Québec, Canada; and McGill University Surgery Department, Montréal, Québec, Canada. PARTICIPANTS: Surgical residents and professors of all specialties within the 4 university surgery departments in Quebec through a voluntary web-based survey. RESULTS: A total of 280 questionnaires were analyzed with response rates of 29.7% and 16.4% for residents and professors, respectively. Data were coded on a scale from 2 (strong improvement perception) to -2 (strong deterioration perception). The professors perceived a higher negative effect than the residents did on the educational environment, i.e., role of autonomy (-0.399 vs. -0.577, p < 0.001), teaching (-0.496 vs. -0.540, p < 0.001), social support (-0.345 vs. -0.535, p < 0.001), and surgical learning (-0.409 vs. -0.626, p < 0.001). The professors also observed a higher negative effect on patients' safety (-0.199 vs. -0.595, p = 0.003) and quality of care (-0.077 vs. -0.421, p = 0.014). The latter was even perceived as unchanged by residents (-0.077, 95% CI: -0.249 to 0.095). The residents perceived a negative effect on their quality of life, whereas the professors believed the contrary (0.500 vs -0.496, p < 0.001). More professors than residents believed residency should be prolonged (80.8% vs. 50.6%, p < 0.001). CONCLUSIONS: Residents and professors perceive a mild negative effect on the educational environment and quality of care, whereas their perception on quality of life is opposite. The professors seem concerned about adequate training to the point of considering increasing training length.

Effect of needle size on cancer detection, pain, bleeding and infection in TRUS-guided prostate biopsies: A prospective trial.

INTRODUCTION: Transrectal ultrasound (TRUS)-guided prostate biopsies using 18G calibre needles are widely used; most often 12-core tissue samples of the peripheral zone are obtained. Although the diagnostic yield of prostate biopsies is fair, there is still a potential for false negative results, which necessitates repeat biopsies. In an effort to improve the accuracy of prostate biopsies, different sampling schemes have been developed. One strategy has been to increase the number of core biopsies performed on each patient. Another strategy has been to improve the reliability of prostate biopsies using larger calibre needles, thereby increasing the amount of tissue obtained for each core biopsy. METHODS: After approval by our institutional review board, we prospectively compared two biopsy needle sizes (18G vs. 16G) in relation to prostate cancer diagnosis, pain, bleeding and infection rates on 105 patients. Each patient underwent 6 TRUS-guided prostate biopsies with the standard 18G needle and 6 other biopsies with the experimental 16G needle. To evaluate possible complications related to the use of a larger 16G needle in the experimental group, we compared pain, bleeding and infection rates with a control group of 100 patients who underwent 12 biopsies with a single 18G needle (18G group). Pain, bleeding assessment and infection events were evaluated using patient questionnaires and telephone interviews. RESULTS: TRUS-guided prostate biopsies using 16G calibre needles did not increase cancer detection or non-malignant pathology rate, including prostatic intraepithelial neoplasia (PIN) and atypical small acinar proliferatio (ASAP). Pain, bleeding and infectious complications were similar in both groups. Infection was defined as temperature above 38°C occurring within 48 hours after the procedure. We identified 4 patients with post-biopsy fever in the experimental (16/18G) group and 4 other patients in the (18G) control group. The post-biopsy infection rate is higher than reported just a few years ago and indicates that quinolone resistant Escherichia coli seems to be more prevalent in our urban setting than previously suspected. Limitations to our study include small group numbers. CONCLUSION: Larger 16G needles appear to be safe for TRUS-guided prostate biopsies. Further study in a larger, multi-institutional, prospective, randomized manner with 16G needles is warranted to assess the theoretical benefit of larger core biopsies in prostate cancer detection.

Training and outcome monitoring in robotic urologic surgery.

The use of robot-assisted laparoscopic technology is rapidly expanding, with applicability in numerous disciplines of surgery. Training to perform robot-assisted laparoscopic urological procedures requires a motivated learner, a motivated teacher or proctor, a curriculum with stepwise learning objectives, and regular access to a training robot. In light of the many constraints that limit surgical training, animal models should be utilized to quantifiably improve the surgical skills of residents and surgical fellows, before these skills are put into practice on patients. A system based on appropriate supervision, graduated responsibility, real-time feedback, and objective measure of progress has proven to be safe and effective. Surgical team education directed towards cohesion is perhaps the most important aspect of training. At present, there are very few published guidelines for the safe introduction of robotic urologic surgery at an institution. Increasing evidence demonstrates the effects of learning curve and surgical volume on oncological and functional outcomes in robotic surgery (RS). This necessitates the introduction of mechanisms and guidelines by which trainee surgeons can attain a sufficient level of skill, without compromising the safety of patients. Guidelines for outcome monitoring following RS should be developed, to ensure patient safety and sufficient baseline surgeon skill.

Efficacy of botulinum toxin A injection for neurogenic detrusor overactivity and urinary incontinence: a randomized, double-blind trial.

PURPOSE: We determined the efficacy of onabotulinumtoxinA for neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis. MATERIALS AND METHODS: In a prospective, double-blind, multicenter study 57 patients 18 to 75 years old with neurogenic detrusor overactivity secondary to spinal cord injury or multiple sclerosis and urinary incontinence (defined as 1 or more occurrences daily) despite current antimuscarinic treatment were randomized to onabotulinumtoxinA 300 U (28) or placebo (29) via cystoscopic injection at 30 intradetrusor sites, sparing the trigone. Patients were offered open label onabotulinumtoxinA 300 U at week 36 and followed a further 6 months while 24 each in the treatment and placebo groups received open label therapy. The primary efficacy parameter was daily urinary incontinence frequency on 3-day voiding diary at week 6. Secondary parameters were changes in the International Consultation on Incontinence Questionnaire and the urinary incontinence quality of life scale at week 6. Diary and quality of life evaluations were also done after open label treatment. RESULTS: The mean daily frequency of urinary incontinence episodes was significantly lower for onabotulinumtoxinA than for placebo at week 6 (1.31 vs 4.76, p <0.0001), and for weeks 24 and 36. Improved urodynamic and quality of life parameters for treatment vs placebo were evident at week 6 and persisted to weeks 24 to 36. The most common adverse event in each group was urinary tract infection. CONCLUSIONS: In adults with antimuscarinic refractory neurogenic detrusor overactivity and multiple sclerosis onabotulinumtoxinA is well tolerated and provides clinically beneficial improvement for up to 9 months.

Comparative study of inguinal hernia repair rates after radical prostatectomy or external beam radiotherapy.

PURPOSE: We tested the hypothesis that patients treated for localized prostate cancer with radical prostatectomy (RP) have a higher risk of requiring an inguinal hernia (IH) repair than their counterparts treated with external beam radiotherapy (EBRT). METHODS AND MATERIALS: Within the Quebec Health Plan database, we identified 6,422 men treated with RP and 4,685 men treated with EBRT for localized prostate cancer between 1990 and 2000, in addition to 6,933 control patients who underwent a prostate biopsy. From among that population, we identified patients who underwent a unilateral or bilateral hernia repair after either RP or EBRT. Kaplan-Meier plots showed IH repair-free survival rates. Univariable and multivariable Cox regression models tested the predictors of IH repair after RP or EBRT. Covariates consisted of age, year of surgery, and Charlson Comorbidity Index. RESULTS: IH repair-free survival rates at 1, 2, 5, and 10 years were 96.8, 94.3, 90.5, and 86.2% vs. 98.9, 98.0, 95.4, and 92.2%, respectively, in RP vs. EBRT patients (log-rank test, p < 0.001). IH repair-free survival rates in the biopsy population were 98.3, 97.1, 94.9, and 90.2% at the same four time points. In multivariable Cox regression models, RP predisposed to a 2.3-fold higher risk of IH repair than EBRT (p < 0.001). Besides therapy type, patient age (p < 0.001) represented the only other independent predictor of IH repair. CONCLUSIONS: RP predisposes to a higher rate of IH repair relative to EBRT. This observation should be considered at informed consent.

The rate of secondary malignancies after radical prostatectomy versus external beam radiation therapy for localized prostate cancer: a population-based study on 17,845 patients.

PURPOSE: External-beam radiation therapy (EBRT) may predispose to secondary malignancies that include bladder cancer (BCa), rectal cancer (RCa), and lung cancer (LCa). We tested this hypothesis in a large French Canadian population-based cohort of prostate cancer patients. METHODS AND MATERIALS: Overall, 8,455 radical prostatectomy (RP) and 9,390 EBRT patients treated between 1983 and 2003 were assessed with Kaplan-Meier and Cox regression analyses. Three endpoints were examined: (1) diagnosis of secondary BCa, (2) LCa, or (3) RCa. Covariates included age, Charlson comorbidity index, and year of treatment. RESULTS: In multivariable analyses that relied on incident cases diagnosed 60 months or later after RP or EBRT, the rates of BCa (hazard ratio [HR], 1.4; p = 0.02), LCa (HR, 2.0; p = 0.004), and RCa (HR 2.1; p <0.001) were significantly higher in the EBRT group. When incident cases diagnosed 120 months or later after RP or EBRT were considered, only the rates of RCa (hazard ratio 2.2; p = 0.003) were significantly higher in the EBRT group. In both analyses, the absolute differences in incident rates ranged from 0.7 to 5.2% and the number needed to harm (where harm equaled secondary malignancies) ranged from 111 to 19, if EBRT was used instead of RP. CONCLUSIONS: EBRT may predispose to clinically meaningfully higher rates of secondary BCa, LCa and RCa. These rates should be included in informed consent consideration.

Comparative study of inguinal hernia repair after radical prostatectomy, prostate biopsy, transurethral resection of the prostate or pelvic lymph node dissection.

PURPOSE: Inguinal hernia is considered one of the major morbidities after radical prostatectomy. We compared inguinal hernia repair rates in patients treated with radical prostatectomy for localized prostate cancer relative to those of 2 nonsurgically treated groups of patients, namely individuals who underwent prostate biopsy or transurethral resection of the prostate, and a surgically treated group of patients who underwent pelvic lymph node dissection, within a large North American database. MATERIALS AND METHODS: Using the Quebec Health Plan database we identified 5,478 men treated with radical prostatectomy vs 6,933, 7,697 and 532 who underwent prostate biopsy, transurethral resection of the prostate or pelvic lymph node dissection, respectively, between 1990 and 2000. Kaplan-Meier plots graphically explored inguinal hernia repair rates. Univariable and multivariable Cox regression analyses examined variables associated with inguinal hernia repair after either group. Covariates consisted of age, year of treatment and the Charlson comorbidity index. RESULTS: The 1, 2, 5 and 10-year inguinal hernia repair rates after radical prostatectomy were 4.4%, 6.7%, 11.7% and 17.1%, respectively. For the same points after prostate biopsy the rates were 1.7%, 2.9%, 6.1% and 9.8% vs 1.7%, 2.6%, 5.5% and 9.2%, respectively, after transurethral resection of the prostate, and 0.8%, 2.4%, 4.9% and 9.3% after pelvic lymph node dissection (pairwise log rank tests p <0.001). On multivariable Cox regression analyses the rate of inguinal hernia repair was 1.9, 2.1 and 1.7-fold higher for patients who underwent radical prostatectomy vs prostate biopsy, transurethral resection of the prostate and pelvic lymph node dissection, respectively (all p <0.001). CONCLUSIONS: Radical prostatectomy predisposes to higher inguinal hernia repair rates than in the 3 examined control groups. A higher rate of inguinal hernia repair after radical prostatectomy warrants consideration in the discussion of radical prostatectomy perioperative complications.

Thirty-day mortality after transurethral resection of the prostate in patients treated with androgen deprivation therapy.

BACKGROUND AND PURPOSE: Seven percent of patients with prostate cancer (PCa) who are exposed to androgen deprivation therapy (ADT) may need transurethral resection of the prostate (TURP). Our objective was to examine the rate and the predictors of 30-day mortality (30dM) after TURP in patients who were exposed to ADT in a large, contemporary Canadian cohort. PATIENTS AND METHODS: We assessed the 30dM rate after TURP in 853 men with the diagnosis of PCa who were treated with primary ADT or radiation therapy followed by ADT. The effect of age, comorbidity (coded according to the Charlson Comorbidity Index [CCI]), number of previous TURP procedures, history of radiation therapy, exposure to antiandrogens, and the type and the duration of ADT before TURP were all tested in univariable and multivariable logistic regression models that predicted 30dM after TURP. RESULTS: During the initial 30 days after TURP, 38 deaths occurred (4.5%, 95% confidence interval: 3.2%-6.2%). Of all variables, the CCI was the only statistically significant (P = 0.001) predictor of 30dM after TURP. The accuracy of CCI in predicting 30dM after TURP in individual patients was 65.1%. Lack of consideration of clinical variables that could predict the 30dM rate after TURP, such as prostate size or prostate-specific antigen level, represents a limitation of this study. CONCLUSIONS: A substantial risk of 30dM is associated with TURP that is performed in patients who are exposed to ADT. Unfortunately, the predictors used in this analysis could not define the individual risk of 30dM with sufficient accuracy. Nonetheless, the average 4.5% risk should be considered at the time of informed consent.

Development and external validation of a highly accurate nomogram for the prediction of perioperative mortality after transurethral resection of the prostate for benign prostatic hyperplasia.

PURPOSE: Benign prostatic hyperplasia affects 60% of men at the age of 60 years. Transurethral resection of the prostate is the gold standard of therapy. We assessed the 30-day mortality rate after transurethral resection of the prostate for benign prostatic hyperplasia, identified risk factors related to 30-day mortality and developed a model that discriminates among individual 30-day mortality risk levels. MATERIALS AND METHODS: We performed development (7,362) and external validation (7,362) of a multivariable logistic regression model predicting the individual probability of 30-day mortality after transurethral resection of the prostate based on an administrative data set (Quebec Health Plan) of 14,724 patients 43 to 99 years old treated between January 1, 1989 and December 31, 2000. RESULTS: Overall 30-day mortality occurred in 58 patients (0.4%) undergoing transurethral resection of the prostate. On univariable analyses increasing age (p <0.001) and increasing Charlson comorbidity index (p <0.001) were statistically significant predictors of 30-day mortality after transurethral resection of the prostate. Conversely annual surgical volume was not. On multivariable analyses age (p <0.001) and Charlson comorbidity index (p <0.001) reached independent predictor status. The accuracy of the age and Charlson comorbidity index based nomogram that predicts the individual probability of 30-day mortality after transurethral resection of the prostate was 83% in the external validation cohort. CONCLUSIONS: Age and Charlson comorbidity index are important determinants of 30-day mortality after transurethral resection of the prostate. The combination of these parameters allows an 83% accurate prediction of individual 30-day mortality risk after transurethral resection of the prostate. Despite limitations such as the need for additional external validations and possibly the need for inclusion of clinical parameters, the use of the current model is warranted for the purpose of informed consent before transurethral resection of the prostate and/or for patient counseling.

A population based assessment of perioperative mortality after cystectomy for bladder cancer.

PURPOSE: Large variability exists in the rates of perioperative mortality after cystectomy. Contemporary estimates range from 0.7% to 5.6%. We tested several predictors of perioperative mortality and devised a model for individual perioperative mortality prediction. MATERIALS AND METHODS: We relied on life tables to quantify 30, 60 and 90-day mortality rates according to age, gender, stage (localized vs regional), grade, type of surgery (partial vs radical cystectomy), year of cystectomy and histological bladder cancer subtype. We fitted univariable and multivariable logistic regression models using 5,510 patients diagnosed with bladder cancer and treated with partial or radical cystectomy within 4 SEER (Surveillance, Epidemiology, and End Results) registries between 1984 and 2004. We then externally validated the model on 5,471 similar patients from 5 other SEER registries. RESULTS: At 30, 60 and 90 days the perioperative mortality rates were 1.1%, 2.4% and 3.9%, respectively. Age, stage and histological subtype represented statistically significant and independent predictors of 90-day mortality. The combined use of these 3 variables and of tumor grade resulted in the most accurate model (70.1%) for prediction of individual probability of 90-day mortality after cystectomy. CONCLUSIONS: The accuracy of our model could potentially be improved with the consideration of additional parameters such as surgical and hospital volume or comorbidity. While better models are being developed and tested we suggest the use of the current model in individual decision making and in informed consent considerations because it provides accurate predictions in 7 of 10 patients.

Survival after radical prostatectomy and radiotherapy for prostate cancer: a population-based study.

OBJECTIVE: Based on the natural history of localized prostate cancer, the life expectancy (LE) of men treated with either radical prostatectomy (RP) or definitive external-beam radiotherapy (EBRT) should exceed 10 years. To test this hypothesis, we examined overall survival rates after RP or EBRT in a contemporary population-based cohort. METHODS: Within a population-based cohort we assessed crude survival in 17 570 men diagnosed with prostate cancer who were either treated with RP (n = 9678) or definitive EBRT (n = 7892) between 1989 and 2000. Age and Charlson Comorbidity Index (CCI) score at treatment represented covariates. In order to control for prostate cancer-related mortality, we repeated analyses for 9131 men who did not receive any secondary treatment for prostate cancer. RESULTS: In the entire cohort, the actuarial 10-year survival probability after RP was 75.3%, versus 36.7% after EBRT (p < 0.001). In those who did not receive any secondary treatment, the actuarial 10-year survival probability after RP was 81.1%, versus 30.4% after EBRT (p < 0.001). In multivariate Cox regression models, EBRT was associated with a 2.8-fold (p < 0.001) and 3.9-fold (p < 0.001) higher risk of mortality in the entire cohort and in the cohort without secondary treatment, respectively. Increased CCI score and increased age were also associated with a higher risk of mortality (p < 0.001). CONCLUSION: Some men treated with EBRT and, to a lesser extent, those treated with RP may have insufficient LE to warrant therapy with curative intent. More stringent selection criteria are necessary to avoid overtreatment.

Biopsy core number represents one of foremost predictors of clinically significant gleason sum upgrading in patients with low-risk prostate cancer.

OBJECTIVES: To examine the effect the number of biopsy cores taken has on the rate of clinically significant Gleason sum upgrading (GSU) in patients with low-risk prostate cancer. METHODS: We analyzed the data from 301 patients with low-risk prostate cancer (clinical Stage T1c-T2a, prostate-specific antigen or=10-core) prostate biopsy. Prostate-specific antigen level, clinical stage, biopsy Gleason sum, prostate volume, year of diagnosis, number of biopsy cores taken, and number of positive cores were used as predictors in logistic regression models addressing the rate of clinically significant GSU (defined as upgrading from biopsy Gleason sum 5-6 to radical prostatectomy Gleason sum of >or=7). Regression coefficients were used to estimate the predictive accuracy of individual variables, as well as their combined effect in the prediction of GSU. RESULTS: The median number of biopsy cores taken was 18. Upgrading was recorded in 96 (31.9%). In men assessed with 10-12 cores, the rate of GSU was 47.9% compared with 23.5% if >18 cores were taken (P < .001). In multivariate analyses, the consideration of the variable defining the number of cores added 9.0% (P < .001) to the ability to predict GSU. CONCLUSIONS: Patients with low-risk prostate cancer assessed with fewer biopsy cores are at a substantially greater risk of GSU. The number of biopsy cores taken represents one of the foremost predictors of GSU and should be taken into consideration during clinical decision-making in patients who are candidates for watchful waiting, active surveillance, or brachytherapy.

Development of a highly accurate nomogram for prediction of the need for exploration in patients with renal trauma.

BACKGROUND: To develop and validate a nomogram for predicting the need for renal exploration after renal trauma. METHODS: From 1995 through 2004, 419 consecutive patients presented to our institution with traumatic renal injury. All were randomly divided into a development (50%, n = 210) and a split sample validation cohort (50%, n = 209). Logistic regression models were used to develop a nomogram for prediction of the need for renal exploration after renal trauma. Internal (200 bootstrap resamples) and 50% split sample validations were performed. RESULTS: Overall, 89 patients (21.2%) underwent renal exploration, from which 60.7% (54 of 89) underwent nephrectomy and 39.3% (35 of 89) underwent renorrhaphy. Nine percent of patients with grade II injury underwent renal exploration, 16% with grade III injuries, 41% with grade IV injuries, and 100% of grade V injuries. The kidney injury scale, the mechanism of injury, the need for transfusion, blood urea nitrogen level, and serum creatinine represented the most informative predictors and were included in the nomogram. The split sample accuracy of the nomogram for prediction of the need for renal exploration was 96.9%. It significantly (p < 0.001) exceeded the accuracy of each of its components including the American Association for the Surgery of Trauma kidney injury scale (87.7%). CONCLUSION: The nomogram generates highly accurate and reproducible predictions of the probability for renal exploration according to our decision-making. It could help standardize the management of patients with renal trauma (i.e., inclusion criteria for clinical trials) and serves as a proof-of-principle that predictive tools can be applied to the trauma setting. Its use may improve the management of renal trauma patients at institutions with limited trauma experience.

Accuracy of life tables in predicting overall survival in patients after radical prostatectomy.

OBJECTIVE: To test the accuracy of life tables (LT), the standard tool for predicting life-expectancy (LE), but the accuracy of which is unknown in patients with prostate cancer, where the 10-year LE is a widely accepted threshold for the delivery of definitive therapy. PATIENTS AND METHODS: We tested the accuracy of predictions of LE from LT in 9678 men treated with radical prostatectomy (RP) for prostate cancer. The predictions of LE from LT at 10 years after RP were compared to Kaplan Meier-derived 10-year survival values. Moreover, the accuracy of LT predictions was quantified in a Cox-regression using Harrell's concordance index. To control for the effect of prostate cancer mortality, analyses were repeated in a subset of 5955 patients with no evidence of disease recurrence. Additional stratification schemes were applied to control for age and comorbidity. RESULTS: At RP, the median age was 64 years, the median Charlson Comorbidity Index (CCI) was 1 and the median LT-derived LE was 16 years. The median actuarial survival was not reached (mean 12.4 years). In the whole group the LT-predicted 10-year survival was 96.8%, vs an observed of 75.3%. In men with no disease recurrence the LT-predicted survival was 97.3%, vs 81.1% observed. After age and CCI stratification, LT overestimated the 10-year survival the most in those aged 65-69 years and in patients with CCI scores of >2. CONCLUSION: The overestimation of LE can lead to overtreatment of prostate cancer, especially in those men who die early from other causes.

Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy.

OBJECTIVES: To test the effectiveness of weekly postoperative pelvic floor muscle training (PFMT) versus supportive telephone contact by a urology nurse for men at 4 weeks after radical prostatectomy. METHODS: This was a randomized controlled trial in three Canadian centers. At 4 weeks after surgery, standardized verbal and written instruction about PFMT was provided to all subjects. Randomization occurred after initial instruction. Continence was defined as 8 g or less of urine loss on a 24-hour pad test. Primary outcome was grams of urine loss on pad test; secondary outcomes were International Prostate Symptom Score (IPSS), Incontinence Impact Questionnaire (IIQ-7) score, cost, and perception of urine loss as a problem. Data were obtained at baseline (preoperatively) and at weeks 4, 8, 12, 16, and 28 and 1 year after surgery. RESULTS: A total of 216 men were enrolled; 11 were dry or withdrew at 4 weeks. Ninety-nine were randomized to the control group and 106 to the treatment group. There were no group differences at baseline for prostate-specific antigen level (mean [standard deviation] 8.4 [10.4] ng/mL; 7.6 [4.6] ng/mL), Gleason score (6.3 [0.86]), IPSS, IIQ-7 score, pad test, or voiding diary. At 8 weeks 23% of the control group and 20% of the treatment group were continent; at 12 weeks, 28% and 32%; 16 weeks, 40% and 44%; 28 weeks, 50% and 47%; and at 52 weeks, 64% and 60%, respectively. There were no significant differences between groups at any time point for the outcome variables. CONCLUSIONS: Verbal instruction and written information with telephone support seemed to be as effective as intensive PFMT. Less-intense therapy may be more cost-effective.

Lower urinary tract symptoms affect one-third of men in a prostate cancer screening population.

PURPOSE: Lower urinary tract symptoms (LUTS) are common in elderly men. Radical prostatectomy may relieve obstructive symptoms, whereas radiation therapy may exacerbate obstructive or irritative symptoms. Baseline LUTS rates are unknown in populations screened for prostate cancer (PCa). Thus, it is difficult to determine the changes in LUTS that can be attributed to PCa treatment. Therefore, we assessed baseline rates of LUTS in a PCa screening cohort and assessed which of the International Prostate Symptom Score (IPSS) symptoms had the most detrimental effect on quality of life (QoL). METHODS: The IPSS was completed by 1273 men without clinical evidence of PCa who participated in an annual PCa screening event. Presence of irritative or obstructive symptoms was considered when they were reported at least two of five times. Using linear regression analyses, we evaluated the effect of each questionnaire symptom on the IPSS QoL domain. RESULTS: Mean age was 57.6 years (range 40-89 years). Of all in the cohort, 40% (n = 472) reported moderate to severe LUTS (IPSS score > or =8), and 21% (n = 255) were mostly dissatisfied with this condition. Irritative symptoms were reported by 39% (n = 495) and obstructive symptoms by 37%. Of all IPSS symptoms, urinary straining was associated with the least favorable QoL, followed by urinary frequency. CONCLUSION: More than one-third of persons at risk of PCa are affected by either irritative or obstructive symptoms, and one in five of these men is bothered by LUTS. Because PCa treatment may exacerbate LUTS, the severity and impact on QoL should be considered carefully before diagnosis and/or treatment.

Baseline prevalence of erectile dysfunction in a prostate cancer screening population.

INTRODUCTION: Erectile dysfunction (ED) is common in older men and can be worsened by prostate cancer (PCa) treatment. True ED rates before PCa treatment are mandatory, in order to assess the rate of ED attributable to PCa treatment. Data derived from population-based studies or from patients surveyed after PCa diagnosis, as well as just prior to treatment may not represent a valid benchmark, as health profiles of the general population might be different to those undergoing PCa screening or as anxiety may worsen existent ED. AIM: To circumvent these limitations, we assessed the baseline rate of ED in PCa diagnosis-free men participating in a PCa awareness event. METHODS: ED was classified according to the International Index of Erectile Function (IIEF) score as absent (IIEF: 25-30), mild (22-24), mild to moderate (17-21), moderate (11-16), or severe (