Novel immediate/sustained-release formulation of acetaminophen-ibuprofen combination (Paxerol®) for severe nocturia associated with overactive bladder: A multi-center, randomized, double blinded, placebo-controlled, 4-arm trial.

AIM: To determine short-term efficacy and safety of Paxerol®, novel immediate:sustained (50%:50%) release tablets containing 325 mg acetaminophen and 150 mg ibuprofen per tablet. METHODS: One of three dose levels, corresponding to the amounts in 1, 2, and 3 tablets, of Paxerol and placebo were administered for 14 consecutive days to patients with severe nocturia (defined in this study as an average nocturnal voids [NV] ≥2.5) associated with overactive bladder (OAB). Changes in NV, as well as Nocturia Quality of Life (NQOL), duration of first uninterrupted sleep (DFUS), and total hours of nightly sleep (THNS) associated with treatment were assessed. Short-term safety/tolerability was assessed throughout the study and for at least 30 days post-treatment. RESULTS: Paxerol at all three doses reduced NV to a greater degree than placebo (average NV -1.1, -1.4, -1.3 voids for low, mid, and high doses, respectively, vs -0.3 void for placebo). NQOL and THNS were similar between baseline and treatment values in all four groups. There were also no between-group differences. Paxerol at high dose tended to (although not statistical significantly) increase DFUS to a greater degree than placebo (1.2 vs 0.4 h, P = 0.057). There were no treatment related adverse events in any of the four groups. CONCLUSIONS: This study demonstrates short-term efficacy and short-term safety of Paxerol in patients with severe nocturia associated with OAB. The results warrant further investigation of the long-term efficacy and safety of Paxerol in larger patient populations.

Case report: renal infarct mimicking renal mass: further rationale for minimally invasive management.

A 55-year-old man presented with an exophytic asymptomatic right renal lower-pole mass simulating a renal-cell carcinoma. He underwent retroperitoneoscopic partial nephrectomy, and histopathologic examination revealed a chronic renal infarct with calcifications. We report this case to stimulate the inclusion of focal chronic renal infarct in the differential diagnosis of asymptomatic renal masses, as well as to advocate a minimally invasive approach to appropriate renal lesions.

Impact of type of anesthesia on efficacy of medstone STS lithotripter.

PURPOSE: To evaluate the impact of the type of anesthesia on treatment efficacy, using a comparison of general anesthesia (GEN) and monitored anesthesia care with intravenous sedation (MAC), for patients undergoing extracorporeal shockwave lithotripsy (SWL) on the Medstone STS lithotripter. PATIENTS AND METHODS: A case-control study was conducted of 660 patients treated from 1986 to 2002. General anesthesia and MAC were utilized in 330 procedures each. Case matching was performed for stone size, stone location, and body mass index. All lithotripter units were staffed by a rotating schedule of the same 10 SWL-certified radiologic technicians. Patient characteristics, treatment parameters, complications, repeat procedures, and secondary procedures were recorded. Stone-free success rates (no residual fragments) were reported by the treating physician on the basis of plain radiographs. Chi-square analysis was used to compare patients in the two groups. RESULTS: The overall stone-free rate was better with GEN (67%) than MAC (55%; P = 0.04). Stone-free rates were not affected for stones 10 mm or in an upper calix. General anesthesia may decrease excursion of the calculus out of the focal area secondary to breathing or patient movement.

A pilot study on the early use of the vacuum erection device after radical retropubic prostatectomy.

OBJECTIVE: To evaluate the effect of the early use of the vacuum erection device (VED) on erectile dysfunction (ED) and penile shortening after radical retropubic prostatectomy (RP), as these are important concerns for men choosing among treatment alternatives for localized prostate cancer. PATIENTS AND METHODS: Twenty-eight men undergoing RP were randomized to early intervention (1 month after RP, group 1) or a control group (6 months after RP, group 2) using a traditional VED protocol. An International Index of Erectile Function (IIEF) score of >11 (no, mild or mild to moderate ED) was required as a baseline criterion for inclusion in the study. Only patients in whom unilateral or bilateral nerves were spared were subsequently randomized. Patients in group 1 followed a daily rehabilitation protocol consisting of 10 min/day using the VED with no constriction ring, for 5 months. Patients were evaluated with the IIEF-5 questionnaire and measurements of penile flaccid length, stretched length, prepubic fat pad, and midshaft circumference before and at 1, 3, 6, 9 and 12 months after RP; the mean (range) last follow-up visit was 9.5 (6-12) months after RP. RESULTS: The mean (sd) baseline IIEF scores were similar in groups 1 and 2, at 21.1 (4.6) and 22.3 (3.3), respectively (P = 0.54). The IIEF scores were significantly higher in group 1 than group 2 at 3 months, at 11.5 (9.4) vs 1.8 (1.4) (P = 0.008) and at 6 months, at 12.4 (8.7) vs 3.0 (1.9) (P = 0.012) after RP. There were no significant changes in penile flaccid length, prepubic fat pad, or mid-shaft circumference in either group. Stretched penile length was significantly decreased at both 3 and 6 months, by approximately 2 cm (P = 0.013) in group 2. By contrast, stretched penile length was preserved in group 1 at all sample times. At the last follow-up, the proportion of men with a mean loss of penile length of >/= 2 cm was significantly lower in group 1 than group 2 (two/17, 12%, vs five/11, P = 0.044). CONCLUSIONS: Initiating the use of a VED protocol at 1 month after RP improves early sexual function and helps to preserve penile length.

Novel technique for removal of misdirected laparoscopic Weck clips.

The Weck clip has emerged as an attractive option for laparoscopic vascular control. It is secure and easy to use. However, once fired, the clip can be difficult to remove. We describe a novel technique for the safe removal of misdirected Weck clips using the Harmonic scalpel.

Aspergillosis of the scrotum: non-surgical management.

Disseminated aspergillar infection involving the genitourinary system is quite rare and often fatal. Only one previous case of aspergillosis of the scrotum has been reported. In the previous report, the patient died despite aggressive surgical debridement. We report a case of aspergillosis involving the scrotum in which the patient did well with conservative medical management.

Novel device to assist urethrovesical anastomosis during laparoscopic radical prostatectomy.

We evaluated a novel urethral sound (Benique sound-Karl Storz) to assist suturing during laparoscopic radical prostatectomy. This sound provides for a more secure grip compared with the traditional sound, thereby affording controlled traction of the gland during the procedure and smooth coordinated movements of the sound during the anastomosis.

Impact of heads-up display imaging on endoscopic task performance.

BACKGROUND AND PURPOSE: Heads-Up Imaging goggles provide ergonomic advantages to the endourologist. This study was designed to evaluate whether heads-up display impacts task performance for ureteroscopic stone retrieval. MATERIALS AND METHODS: The ability to capture a 5-mm calculus with a Cook N-Circle 2.2F stone basket from an inanimate caliceal model was tested by three experienced and three novice stone-basket operators. Visual display for initial testing for each operator was randomized to the OptiVu HD3 Heads-Up googles or a 20- inch Sony Triniton monitor (TV). Subsequent testing alternated between the two devices. Camera input was provided by the Storz telecam SL-NTSC. The HD3 was set up to align the direction of view with the operator's hands, while the TV was aligned at an angle 45 degrees lateral and 30 degrees superior to the operator's direction of view to approximate the traditional room set-up for an endourologic procedure. Each operator performed five basketing trials with each display set-up. RESULTS: Expert operators retrieved calculi more rapidly (9.2 +/- 5.9 seconds) than novice operators (50.7 +/- 48.9 seconds), irrespective of whether a TV monitor or goggle display was utilized as the imaging modality. No significant differences were noted in task performance between the two imaging modalities for the expert (P = b0.60), novice (P = 0.77), or overall (P = 0.91) groups. CONCLUSION: The Optiview Heads-Up goggle display system does not offer advantages in task performance with specific regard to the ability to capture stone fragments with baskets.

Renal responses to atrial natriuretic peptide are preserved in bilateral ureteral obstruction and augmented by neutral endopeptidase inhibition.

PURPOSE: Atrial natriuretic peptide (ANP) contributes to post-obstructive diuresis in bilateral ureteral obstruction (BUO). In this study we examined the activity of neutral endopeptidase (NEP), an enzyme responsible for degradation of ANP, in the kidney in rats subjected to BUO for 24 hours. MATERIALS AND METHODS: Renal function was examined by the clearance method in sham operated rats and BUO rats after obstruction release. Renal responses to an intravenous bolus injection of ANP (5 microg/kg) were studied in sham operated and BUO rats with or without pretreatment with intravenous phosphoramidon (100 microg/kg per minute), a NEP inhibitor. RESULTS: In BUO rats natriuresis and diuresis occurred despite a marked decrease in the glomerular filtration rate (GFR). ANP administration increased GFR and induced marked natriuresis and diuresis in sham operated and BUO rats. Inhibition of ANP degradation by phosphoramidon induced natriuresis and diuresis, and accentuated these renal responses to ANP. CONCLUSIONS: Renal responses to ANP and renal NEP activity were preserved in 24-hour BUO. NEP inhibition to attenuate ANP degradation augmented responses to ANP in increasing GFR, natriuresis and diuresis. These findings provide the theoretical potential for facilitating the recovery of GFR after BUO release by inhibiting ANP degradation by pharmacological means.