Are complications of transrectal ultrasound-guided biopsies of the prostate gland increasing?

Although transrectal ultrasound-guided biopsies (TRUSB) of the prostate gland are generally considered to be low-risk procedures, a study from Canada reported that there had been a significant increase in the percentage of hospital admissions following TRUSBs between 1996 and 2005 (1.0% to 4.1%). The authors speculated that the increase may be secondary to the emergence of antibiotic-resistant enteric bacteria or the result of an increasing number of cores taken with each TRUSB. In a chart review, we retrospectively evaluated complications from 2,080 consecutive TRUSBs performed by one urology group in Connecticut between January 2003 and August 2010. We identified seven patients (0.34%) who were admitted to an acute-care hospital for infectious complications and three patients (0.14%) who were admitted for bleeding. The risk of serious infections and bleeding did not significantly rise during the study period despite a significant increase in the mean number of biopsy cores taken.

Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms.

OBJECTIVE: It is widely recognized that patient perception of overactive bladder (OAB) symptoms can vary considerably from mild to severe bother. This post hoc analysis reports outcomes in patients with severe OAB symptoms at baseline taken from the VESIcare Efficacy and Safety in PatieNts with Urgency Study (VENUS). METHODS: VENUS was a 12-week, randomized, double-blind, placebo-controlled trial of solifenacin (5 or 10 mg/day, flexibly dosed) in OAB patients. The primary endpoint in VENUS was mean change from baseline to study end in urgency episodes/day using 3-day bladder diaries. Secondary endpoints included other diary endpoints (frequency, incontinence, and nocturia), warning time (WT; time between first sensation of urgency to voiding), and patient-reported outcome (PRO) measures of urgency (the Indevus Urgency Severity Scale [IUSS] and Urgency Perception Scale [UPS]) and of symptom bother and health-related quality of life (HRQL) (the Patient Perception of Bladder Condition [PPBC] and Overactive Bladder Questionnaire). For this analysis, severe OAB was defined as baseline PPBC score ≥5 (1 = no problems, 6 = many severe problems). TRIAL REGISTRATION: NCT00454896. RESULTS: In total, 158/707 (22.3%) patients in the full analysis set (FAS) reported severe OAB symptoms. Solifenacin reduced mean urgency episodes/day versus placebo in the severe subgroup (-4.6 vs. -3.1, p = 0.1150), similar to the significant reduction observed in the FAS (-3.9 vs. -2.7, p < 0.0001). Solifenacin also improved the other diary endpoints and PRO measures in the severe subgroup; these changes were consistent with the significant solifenacin- versus placebo-related improvements for the FAS. Treatment-emergent adverse events were mostly mild/moderate, and few patients taking solifenacin or placebo discontinued treatment in the severe subgroup (4.5% vs. 6.5%) or FAS (6.5% vs. 4.6%). Key limitations are that VENUS was not powered to detect treatment differences in subgroups, and that the lack of a standardized definition of OAB symptom severity may limit the generalizability of the findings. CONCLUSIONS: Patients with severe OAB symptoms showed objective and subjective improvements in symptoms, symptom bother, HRQL, and urgency severity with solifenacin similar to the FAS. Solifenacin was also well-tolerated in this subgroup.

Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial.

OBJECTIVE: Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported. MATERIALS AND METHODS: In this 12-week multicenter trial, 739 patients (aged >or= 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo. Prespecified secondary PRO measures included the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). Appropriate statistical tests compared treatment-group differences in continuous and categorical data. RESULTS: In the full analysis set, patients who received solifenacin (n = 357) versus placebo (n = 350) showed significant improvements on the IUSS and UPS; treatment-group differences were 0.4 (P < 0.0001) and 0.2 (P = 0.0018), respectively. On the PPBC, significantly more patients taking solifenacin (66%) than placebo (48%) perceived fewer bladder-related problems (P < 0.0001) by week 12. On the OAB-q, solifenacin was superior to placebo for the Symptom Bother and total HRQL scales and for 3 of the 4 HRQL domains at study end (P

Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: In this double-blind, placebo-controlled trial, we assessed the efficacy and tolerability of solifenacin treatment for overactive bladder (OAB) with a focus on urgency-related endpoints. Changes in number of urgency episodes were evaluated as the primary endpoint; secondary endpoints included changes in conventional diary-based OAB symptoms. We also measured warning time (defined as the time from first sensation of urgency to voiding). METHODS: We randomized patients (n = 739) to once-daily solifenacin or placebo for 12 weeks. Solifenacin 5 mg or matching placebo was administered for 4 weeks; dose could be maintained or adjusted at weeks 4 and 8. Participants completed 3-day micturition diaries at multiple study visits; warning time was recorded at baseline and week 12. RESULTS: At study end, the mean number of urgency episodes per 24 hours decreased by 3.91 (from 6.15 to 2.24) with solifenacin and by 2.73 (from 6.03 to 3.30) with placebo (P < .0001 between groups). Other diary-recorded symptoms (incontinence and micturition frequency) were also significantly more reduced with solifenacin compared with placebo. Median warning time increased 31.5 seconds (baseline, 67.8 seconds) with solifenacin, significantly longer (P = .008) than the median increase of 12.0 seconds (baseline, 65.0 seconds) observed with placebo. CONCLUSIONS: Solifenacin treatment significantly reduced episodes of urgency and other key symptoms of OAB. Solifenacin is the first antimuscarinic to demonstrate significant warning time improvement at approved dosing, as shown in a large OAB study population. This is the largest OAB clinical trial yet conducted to evaluate warning time and diary variables in the same study population.

Adaptation of adults to uncorrected hypospadias.

OBJECTIVES: Surgery has been advocated for children with hypospadias to improve the appearance of the penis, allow voiding in the standing position, and improve the chance of fertility. We undertook a survey of adults with hypospadias to determine their adaptation to this congenital anomaly without surgical correction. METHODS: In a 2-year prospective study, six urologists in the general practice of urology identified 56 adult patients from their practices with hypospadias. The urethral meatus was glanular in 21 patients, subcoronal in 23, distal penile in 7, mid-penile in 4, and proximal penile in 1. Nine patients had undergone failed or incomplete hypospadias repairs as children. Seven patients had mild to moderate chordee. RESULTS: Only 1 patient presented with a complaint referable to the hypospadias, and only 3 (5%) of the 56 patients expressed dissatisfaction with the appearance of their penis. Of the 56 patients, 18 (32%) stated that they were unaware that they had a congenital anomaly. The 2 patients who were known to be infertile were believed to be infertile on the basis of oligospermia. Although 20 (36%) of the 56 patients described angulation or spraying of the urinary stream, only 3 (5%) stated that they preferentially sat to void. No patient pursued an interest in corrective surgery. CONCLUSIONS: Of the adults we surveyed with hypospadias, most stated that they were satisfied with the appearance of the penis, voided in the standing position, and did not have infertility associated with the abnormal position of the urethral meatus.