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.

Preliminary findings with the Solyx single-incision sling system in female stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to test the safety and efficacy of the Solyx single-incision sling (SIS) in women with stress urinary incontinence (SUI). METHODS: A retrospective study of 63 women who had undergone implantation at three medical centers (December-March 2009) was conducted. RESULTS: Mean patient age was 51 years (range, 30-87 years); 37 (59%) patients had concomitant urogynecological procedures. At a mean follow-up of 6.5 months (range, 5-8 months), 95% of patients were dry on the basis of subjective and objective assessment. Two patients experienced transient urinary retention, which resolved spontaneously. No complications of the procedure were reported, including no bladder, bowel, vessel, or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. CONCLUSIONS: The very early efficacy results indicate that the Solyx SIS system is an attractive treatment option for SUI. The minimal number of steps involved in the procedure will facilitate uptake of the technique.

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.

Thoughts on midurethral synthetic slings.

Since the early 1900s, there have been many attempts to correct stress urinary incontinence (SUI) in women. Over the years, it became accepted that the most effective way to correct SUI involved a procedure that supports the urethra. This simple premise spurred major innovations in the 1970s and 1980s by Shlomo Raz and Tom Stamey, many of which proved difficult to reproduce and were not universally accepted. In the mid-1990s, however, Ulf Ulmsten and Peter Petros revolutionized treatment of SUI, using a synthetic sling at the midurethra in a tension-free fashion. The urologic and urogynecologic world forever changed. In the last decade, further innovations have been based on these principles. There are currently three main types of synthetic sling procedures, including the retro-pubic synthetic sling, the obturator synthetic sling, and the single-incision synthetic sling.

Effectiveness and tolerability of extended-release oxybutynin vs extended-release tolterodine in women with or without prior anticholinergic treatment for overactive bladder.

The efficacy and the tolerability of extended-release oxybutynin chloride, 10 mg daily, and extended-release tolterodine tartrate, 4 mg daily, in women with or without prior anticholinergic treatment for overactive bladder (OAB) were compared in a post-hoc analysis of data from the Overactive Bladder: Performance of Extended Release Agents (OPERA) trial. The patient population and study methods have been described previously (Diokno et al., for the OPERA Study Group, Mayo Clin Proc 78:687-695, 2003). Among the group with anticholinergic experience, extended-release oxybutynin was significantly more effective than extended-release tolterodine in reducing micturition frequency at last observation (p=0.052). Complete freedom from urge incontinence was reported by significantly more patients taking oxybutynin than tolterodine at last observation (23.6 vs 15.1%, p=0.038). In addition, among patients completing a full 12 weeks of oxybutynin treatment, significantly greater reductions were observed compared with those taking tolterodine on the primary efficacy variable, number of urge incontinence episodes (p=0.049), and the combined total of urge and non-urge episodes (p=0.012), although the differences between treatment groups were not significant at last observation. In the anticholinergic-naïve group, efficacy and tolerability outcomes were similar across treatments, except that oxybutynin was associated with a significantly lower frequency of micturition at last observation (p=0.035). No efficacy differences favoring tolterodine were observed, and tolerability of the treatments was comparable. Dry mouth (mostly mild to moderate in severity) was reported significantly more often among participants taking extended-release oxybutynin than extended-release tolterodine (32.2 vs 19.2%, p=0.004), but only among those with previous anticholinergic experience. Discontinuation rates were comparably low across groups. The results demonstrate the appropriateness of initiating treatment for OAB with extended-release oxybutynin, particularly in women presenting with incontinence.

The wet patient: understanding patients with overactive bladder and incontinence.

Overactive bladder (OAB) is a constellation of lower urinary tract symptoms, including urinary frequency and urgency,which can occur with or without urinary incontinence. Incontinence is present in over half of female patients with OAB. This condition affects more than 33 million Americans and imposes considerable economic, social, and psychological burdens. Although continued improvements in the pharmacologic management of lower urinary tract disorders have led to the availability of well-tolerated, characteristic features, prevalence and epidemiology, effective treatment options, the symptoms of OAB are generally underreported by patients and under treated by healthcare professionals. Heightened awareness of the multifaceted disease burden imposed by OAB and increased understanding of the characteristics of patients who are likely to be most severely affected, in particular those who suffer from incontinence, may improve the timely identification, diagnosis, and clinical management of the syndrome, enhancing both the health and quality of life of these patients. This review will summarize the clinical consequences, and management of OAB, with particular focus on the incontinent patient.

Meta-analysis of four different surgical treatments for stress urinary incontinence.

INTRODUCTION: Multiple surgical approaches for the correction of stress urinary incontinence (SUI) have been described. In an attempt to determine which procedure may be superior, we performed a meta-analysis comparing the needle suspensions (i.e. Gittes, Stamey), Raz, Burch/MMK colposuspension, and urethral sling. METHODS: The most complete 87 of 310 articles relating to the surgical therapy for SUI published between 1982 and 1995 were selected by Medline search for review. These articles incorporated patients operated on from 1965 to 1995. Fixed effects Baysian and variance weighted models were applied to derive estimates and confidence intervals. Bonferroni multiple comparison procedures wee also incorporated. RESULTS: The mean reported success rates were 81% for the needle suspensions, 84% for the Raz, 85% for the colposuspension, and 85% for the sling. There was a significant difference between the sling and needle suspension as well as between the colposuspension and needle suspension (P<0.05). There was no correlation between length of follow-up and the success rate (P>.05). CONCLUSION: There is currently a general impression among urologists that the sling has the best success rates for the treatment of SUI and that the Raz and colposuspension are clinically superior to the needle suspension. Recent literature also indicates a significant increase in the failure rate over time. Our meta-analysis of the best 25% of SUI papers does not support either view entirely. This may be due to publication bias and incomplete reporting by the authors. Prior to developing ever "improved" procedures, urologist must start to report their results in a consistent fashion to allow meaningful conclusions concerning the risks and benefits of our existing procedures.