Regina D. Norris

A Prospective, Randomized, Double-Blinded Placebo-Controlled Comparison of Extended Release Oxybutynin Versus Phenazopyridine for the Management of Postoperative Ureteral Stent Discomfort

OBJECTIVES Ureteral stents commonly cause lower urinary tract and flank discomfort. We evaluated the use of extended release oxybutynin versus phenazopyridine versus placebo for the management of ureteral stent discomfort after ureteroscopy. METHODS Each of 60 patients who received a unilateral stent after ureteroscopy was given a blister pack containing 21 unmarked capsules of either extended release oxybutynin 10 mg, phenazopyridine 200 mg, or placebo in a prospective, randomized, and double-blinded fashion. Patients were instructed to take 1 capsule 3 times daily immediately after the procedure. Patients were given 50 tablets of oral narcotic to be taken as needed. Patients reported bothersome scores for flank pain, suprapubic pain, urinary frequency, urgency, dysuria, and hematuria on postoperative day 1, day 2, and the day of stent removal. Narcotic use was also recorded. RESULTS Eight patients were excluded from the analysis for stent migration necessitating early removal (1), uncontrollable pain (1), failure to complete blister pack (4), and inability to contact for follow-up surveys (2). There was no difference in bothersome score among the groups for flank pain, suprapubic pain, urinary frequency, urgency, and dysuria. The phenazopyridine group reported less hematuria on postoperative day 1 when compared with placebo, which was statistically significant. The oxybutynin group required fewer narcotics, but this finding was not statistically significant. CONCLUSIONS Although this study failed to show a significant difference in bothersome scores among the groups, the small sample size precludes definitive conclusion. Future studies pooling these data will determine the overall treatment effect and the optimal management of ureteral stent morbidity.

Evaluating the Evidence: Statistical Methods in Randomized Controlled Trials in the Urological Literature

PURPOSE Randomized controlled trials potentially provide the highest level of evidence to inform clinical decision making. Appropriate use of statistical methods is a critical aspect of all clinical research, including randomized controlled trials. We report the first formal evaluation to our knowledge of the statistical methods of randomized controlled trials published in the urological literature in 1996 and 2004. MATERIALS AND METHODS All human subjects randomized controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers with formal training in research design and biostatistics who were blinded to study authors and institution. Discrepancies were settled by consensus. RESULTS A total of 152 randomized controlled trials were reviewed (65 in 1996, 87 in 2004). The median sample size (IQR) per arm of parallel design randomized controlled trials published in 1996 and 2004 was 36 (11, 96) and 50 (26, 134) study subjects, respectively (p = 0.157). Sample size justifications were provided by 19% of studies in 1996 and 47% of studies in 2004 (p = 0.001). Of randomized controlled trials 16 (25%) vs 32 (37%) identified a single primary outcome variable (p = 0.110). Effect size estimates for primary or secondary outcome variables were provided by 5% vs 13% (p = 0.090) and the precision of the effect was detailed by 5% vs 10% of randomized controlled trials (p = 0.195). CONCLUSIONS This formal review suggests that statistical analysis in urological randomized controlled trials has improved. However, considerable deficiencies remain. Ongoing education in applied statistics may further improve urological randomized controlled trial reporting.

Levels of evidence ratings in the urological literature: an assessment of interobserver agreement

To determine to what extent urologists with no specific training agree upon level of evidence (LoE) ratings of studies published in the urological literature, as LoE are commonly referenced as a measure of evidence quality.

Single-site Laparoscopic Orchidopexy in an Infant

We describe a laparoscopic orchidopexy performed on an 18-month-old child through a single infraumbilical site.

Endoscopic stone management in children.

Purpose of review The management of urolithiasis in children has significantly changed over the past 20 years. Extracorporeal shockwave lithotripsy (SWL) was initially the preferred modality of treatment. More recently, ureteroscopy and percutaneous nephrolithotomy (PCNL) are being used at an increasing frequency in the management of pediatric stone disease. Recent findings Development has been made in various aspects of pediatric endoscopic stone management. Ureteroscopy and PCNL have been applied at an increasing frequency to treat pediatric stone disease, which has guided modifications to improve the procedures. Increased endoscopic experience with managing urolithiasis has broadened the indications wherein these methods are utilized. Technology is continually advancing to meet the needs of this population. Ureteroscopes have been modified to accommodate the pediatric ureter, optics advanced, and access sheaths are used to improve results. In addition, technique is constantly being refined. Summary Further experience will direct surgeons as to when ureteroscopy and PCNL are appropriate. The incidence of urolithiasis is on the rise in developing nations; there is a need to address the most efficient method of treatment that minimizes the morbidity to the child.