Alfred Kohan

INDINAVIR UROLITHIASIS: AN EMERGING CAUSE OF RENAL COLIC IN PATIENTS WITH HUMAN IMMUNODEFICIENCY VIRUS

PURPOSE We evaluate the clinical, diagnostic and radiographic findings in patients on indinavir therapy who presented with renal colic, and propose appropriate treatment options for indinavir urolithiasis. MATERIALS AND METHODS A total of 16 patients positive for human immunodeficiency virus on indinavir were evaluated for 18 episodes of severe renal colic requiring hospitalization. Laboratory evaluation was performed in all patients followed by an imaging study. Conservative treatment included intravenous hydration, narcotic analgesics and temporary cessation of indinavir. Intervention was elected only in patients with persistent fever or intractable pain. A month after hospital discharge an excretory urogram and metabolic stone evaluation were performed. Mean followup was 9.3 months and 2 patients had recurrent symptoms. RESULTS All patients presented with nausea or vomiting and hematuria. Imaging studies confirmed obstruction in all patients with 13 radiolucent (indinavir) and 3 radiopaque (calcium oxalate) stones. Patients with radiolucent and radiopaque stones demonstrated significant differences in urinary pH (p = 0.002) and serum creatinine (p = 0.03). Conservative therapy was successful in 11 patients (68.8%) within 48 hours and 4 patients (25%) with radiolucent calculi required endoscopic stenting for persistent fever. Metabolic stone evaluation demonstrated significant hypocitruria (less than 50 mg./24 hours) in all patients with radiolucent calculi. CONCLUSIONS The urologist should be familiar with this growing cause of renal colic in patients on indinavir therapy. Pure indinavir stones are radiolucent and have a soft, gelatinous endoscopic appearance. Conservative treatment is successful in most patients and if intervention is deemed medically necessary, endoscopic stent placement should be the procedure of choice.

The perioperative charge equivalence of interstitial brachytherapy and radical prostatectomy with 1-year followup

PURPOSE We compare the comprehensive 1-year charges in a consecutive group of patients undergoing radical prostatectomy and transperineal interstitial brachytherapy for clinically localized prostate cancer at a single urban institution. MATERIALS AND METHODS A total of 60 consecutive men with clinically localized prostate cancer (T1-T2, N0, M0) were treated during a 15-month period with radical prostatectomy or interstitial brachytherapy. Hospital and outpatient records were analyzed for each patient in regard to preoperative, operative and postoperative charges. Parameters included number of encounters, diagnostic and therapeutic interventions, hospitalization and operative charges, and followup visits, diagnostic tests and interventions for 1 year. All charge calculations were based arbitrarily on the 1996 Medicare fee schedule, factoring in the mandated global charge reimbursement period of 90 days for both procedures. RESULTS Of the patients 38 underwent radical prostatectomy (prostatectomy group) and 22 underwent interstitial brachytherapy (brachytherapy group). The brachytherapy group was older with higher pretreatment serum prostate specific antigen and clinical stage disease, and more frequently received neoadjuvant hormonal therapy compared to the prostatectomy group. The 2 groups were similar in Gleason score and, when applicable, duration of neoadjuvant hormonal therapy. Preoperative charges were 15.3% lower for prostatectomy than for brachytherapy (not statistically significant). Conversely, operative charges for prostatectomy were 13.5% higher (p = 0.04). The major difference among preoperative, operative and postoperative charges was for those incurred postoperatively by the brachytherapy group, which were 56.0% higher than those for the prostatectomy group (

COST-EFFECTIVE HYDROCELE ABLATION

2,285.20 versus

The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial

1,007.20, p = 0.0004). CONCLUSIONS Transperineal interstitial seed implantation is perceived by many as more cost-effective than radical prostatectomy for patients with clinically localized prostate cancer. We demonstrated that when such patients were followed for 1 year, the comprehensive charges for radical prostatectomy and interstitial brachytherapy were equivalent.

PD26-10 ONABOTULINUMTOXINA PROVIDES EARLY AND CONSISTENT IMPROVEMENTS IN OVERACTIVE BLADDER SYMPTOMS AND QUALITY OF LIFE OUTCOMES IN PATIENTS WITH OVERACTIVE BLADDER

PURPOSE The surgical repair of hydroceles can be relatively expensive in some cases in terms of costs and initial limitation of activity. We ascertain whether aspiration and sclerotherapy of hydroceles is a safe, efficient, cost-effective treatment modality in select patients. MATERIALS AND METHODS In 47 patients 51 hydroceles were treated in the office with aspiration and instillation of a sclerosing solution based on a sodium tetradecyl sulfate preparation. One treatment was done in 14 cases and 2 in the remainder. Medicare data for 1995 were used for charge analysis. RESULTS The overall success rate was 61% (34 of 51 cases) with success defined as no perceptible ipsilateral scrotal fluid reaccumulation on palpation by a physician and complete patient satisfaction. The failure rate was 39% (17 cases) with failure defined as perceptible ipsilateral scrotal fluid reaccumulation on palpation by a physician and/or patient dissatisfaction. The charge differential of surgery versus aspiration and sclerotherapy was greater than 9:1. CONCLUSIONS The aspiration and sclerotherapy technique that we used appears to be an efficacious, safe, cost-effective treatment modality in select patients with idiopathic hydroceles.

Long-Term Efficacy and Safety of OnabotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Who Completed 4 Years of Treatment

Purpose: In this double‐blind, randomized study we compared the efficacy and safety of onabotulinumtoxinA or solifenacin vs placebo in patients with overactive bladder who had urinary incontinence and an inadequate response to or were intolerant of an anticholinergic. Post hoc analysis was done to compare the effects of onabotulinumtoxinA vs solifenacin. Materials and Methods: Solifenacin naïve patients were randomized to onabotulinumtoxinA 100 U, solifenacin 5 mg, (which could escalate to 10 mg at week 6 according to predefined criteria) or placebo. Patients could request treatment 2 (open label onabotulinumtoxinA) after fulfilling prespecified criteria. End points included a change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a 100% reduction (dry) in the number of incontinence episodes per day as co‐primaries, other urinary symptoms and quality of life, all at week 12, and adverse events. Results: The change from baseline in incontinence episodes per day was significantly greater with onabotulinumtoxinA or solifenacin vs placebo (−3.19 or −2.56, respectively, vs −1.33, both p <0.001). The incontinence reduction was significantly greater for onabotulinumtoxinA vs solifenacin (p = 0.022). At week 12, 33.8% (vs placebo p <0.001), 24.5% (vs placebo p = 0.028) and 11.7% of patients receiving onabotulinumtoxinA, solifenacin and placebo, respectively, were dry. After treatment 2, which was open label onabotulinumtoxinA, 43.2%, 37.6% and 41.9% of patients in the onabotulinumtoxinA, solifenacin and placebo groups, respectively, were dry. Significant improvements in other urinary symptoms and quality of life were observed for both active treatments. Urinary tract infection in 25.5% of cases and urinary retention in 6.9% were more common with onabotulinumtoxinA. Conclusions: The efficacy of onabotulinumtoxinA and solifenacin was significantly higher than that of placebo. However, onabotulinumtoxinA showed significantly greater decreases in urinary incontinence than solifenacin with a third of patients achieving a 100% incontinence reduction. No unexpected safety signals were observed.

PERIOPERATIVE CHARGE EQUIVALENCE OF RADICAL PROSTATECTOMY AND BRACHYTHERAPY

INTRODUCTION AND OBJECTIVES: OnabotulinumtoxinA (onabotA) 100U was shown to significantly reduce urinary incontinence (UI) and improve quality of life (QOL) at week (wk) 12 after treatment (tx) in overactive bladder (OAB) patients (pts) in 2 large, placebo (pbo)controlled phase 3 trials. The earliest time for tx response was not assessed in the phase 3 trials. Here we present an interim analysis of an ongoing post-marketing study of onabotA tx response and QOL outcomes as early as wk 1 postinjection in OAB pts with UI. METHODS: OAB pts were randomized 1:1 to receive their 1st tx with onabotA 100U (n1⁄4129) or pbo (n1⁄4125). Pts could receive an additional tx with open-label onabotA 100U after fulfilling prespecified criteria. This interim analysis presents data up to wk 12 after tx 1. Assessments at wks 1, 2, 6 and 12 (primary timepoint) postinjection included the proportions of pts who achieved 100% UI reduction (ie, 00dry00; co-primary endpoint) and 75% and 50% UI reduction, mean change from baseline in daily episodes of urgency UI, micturition, nocturia, and in the Incontinence-QOL (I-QOL) total score. Adverse events (AEs) were also assessed. RESULTS: Baseline mean UI episodes/day were 5.4 (onabotA) and 6.0 (pbo). As early as wk 1 after onabotA, significantly higher proportion of pts achieved 100% UI reduction vs pbo (24.0% vs 4.8%) and continued through wk 2 (25.6% vs 5.6%), wk 6 (32.6% vs 8.0%) and wk 12 (31.8% vs 7.2%) (P<.001 for all timepoints). Similarly, a significantly higher proportion of onabotA-treated vs pbo pts achieved 75% and 50% UI reduction as early as wk 1 (45.0% vs 20.8%, and 58.9% vs 36.0%, respectively; P<.001 for both) which continued through wk 12. Decreases were noted with onabotA vs pbo in other urinary symptoms as early as wk 1 and continued through wk 12. The early onset of onabotA response was also evidenced by the significantly greater improvements in I-QOL score at wk 1 (14.3 vs 5.6; P<.001) that were ~1.5x the minimally important difference (MID; +10 points). At wks 2-12 after onabotA, improvements in I-QOL score were consistently ~23x the MID and significantly greater than pbo (P<.001 for all timepoints). OnabotA was well tolerated; urinary tract infection was the most common AE (21.1% vs 6.4%). CONCLUSIONS: This interim analysis showed a significant and consistent tx response with onabotA vs pbo in OAB pts as early as wk 1 postinjection, with significant reductions in UI episodes and improvements in OAB symptoms and QOL outcomes which continued through wk 12. OnabotA was well tolerated.