Gary Karlin

Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial

The durability of key efficacy response parameters and safety of vardenafil was evaluated in a pivotal trial conducted in a broad population of men with erectile dysfunction (ED) in North America. In this randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel-group, 6-month comparison study, men >18 years of age with ED for >6 months received 5-mg, 10-mg, and 20-mg doses of vardenafil as needed for up to 26 weeks. The primary efficacy variables were the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain scores, and the Sexual Encounter Profile (SEP) mean per-patient success rates for penetration (SEP question 2) and maintenance of erections (SEP question 3). Safety data were also collected over time. Improvement in all primary efficacy variables was observed in all vardenafil groups versus placebo. These improvements occurred early and were either sustained or increased through week 26. Vardenafil in 10-mg and 20-mg doses was significantly superior to placebo at all time points for all efficacy variables (P <0.01), and all doses were superior to placebo at endpoint (P <0.001). Most treatment-emergent adverse events (headache, flushing, dyspepsia, and rhinitis) were mild or moderate in intensity, and incidence generally decreased over time. All 3 doses of vardenafil were superior to placebo across all primary efficacy variables and all study time points in a broad range of patients with ED, regardless of etiology or severity. Vardenafil was well tolerated. These results demonstrate that vardenafil provides sustained efficacy with reduced incidence of nuisance side effects over time. High resolution video, medium resolution video, low resolution video.

Endopyelotomy versus open pyeloplasty: comparison in 88 patients

We compared the results of the first 56 consecutive percutaneous corrections of ureteropelvic junction obstruction (endopyelotomy) at our institution with the most recent 32 consecutive cases of open pyeloplasty. The percutaneous procedure required less time (average 89.4 minutes versus 106.4 minutes for an open operation) and entailed less postoperative pain (60 per cent of the patients required an average of 4.7 unit doses of narcotics, whereas 88 per cent of the pyeloplasty patients required an average of 10.3 unit doses). The average hospital stay was less after endopyelotomy (average 6.2 versus 10.0 days) and return to normal activity occurred more quickly (average 19.8 versus 41.5 days). Endopyelotomy was successful in 87.5 per cent of the patients, with all failures being apparent within 6 weeks and they were easily correctable by traditional methods. Reported success rates of pyeloplasty ranged from 95 to 98 per cent.

Complications of Endopyelotomy: Analysis in Series of 64 Patients

We review the complications and failures in our first 64 patients who underwent endopyelotomy. There were 2 intraoperative complications (3.1 per cent) necessitating an open operation. Postoperative complications included leakage around the stent or irritative bladder symptoms, which were treated by repositioning the stent, and 2 instances of ureterovesical stenosis, which have led us to stent the entire ureter in recent cases. There were 7 failures, 4 in patients who in retrospect were not suitable candidates for the percutaneous operation (long stenotic segment and redundant renal pelvis) and 3 for which there was no obvious cause. All failures were apparent soon after removal of the stent that was inserted at the end of the procedure.

Absence of persisting parenchymal damage after extracorporeal shock wave lithotripsy as judged by excretion of renal tubular enzymes

Four renal tubular enzymes, N-acetyl-beta-glucosaminidase, beta-galactosidase, angiotensin-converting enzyme and gamma-glutamyltransferase, were measured in the urine before, and 24 hours and 1 week after extracorporeal shock wave lithotripsy in 20 consecutive patients. Extracorporeal shock wave lithotripsy was performed on the Sonolith 2000 device with the patient under intravenous narcotic sedation with fentanyl. Enzymatic activity per gram of urinary creatinine was consistently but not significantly higher before extracorporeal shock wave lithotripsy than in control subjects. All 4 enzymes were elevated 24 hours after extracorporeal shock wave lithotripsy, with the increases in beta-galactosidase and angiotensin-converting enzyme being statistically significant. However, by 7 days after the procedure the enzymes had decreased to pre-procedure concentrations or below. These data suggest that any renal tubular damage induced by extracorporeal shock wave lithotripsy is of limited magnitude and brief duration.

Vardenafil is effective and well-tolerated for treating erectile dysfunction in a broad population of men, irrespective of age

To assess the efficacy and safety of vardenafil in the treatment of erectile dysfunction (ED) in men of different age groups.

Persistent cloaca and phallic urethra

During the last 8 years 54 children with a persistent cloaca have been treated by one of us (A. P.). The most common associated anomalies involved the urinary tract, with renal agenesis, renal dysplasia, vesicoureteral reflux and megaureter encountered most frequently. Four patients demonstrated the rare entity of an opening at the tip of a pseudophallus and 2 also had an accessory urethra in association with the cloacal malformation. These children exhibited some form of masculinization of the external genitalia with the accessory urethra or cloacal channel assuming a phallic position in an enlarged clitoris. No adrenal, metabolic or chromosomal abnormalities were detected and virilization was limited to the genitalia. These cases illustrate the greater predilection of these patients to more complex congenital malformations than patients with an isolated cloaca. The posterior sagittal approach has been used effectively for repair of these congenital malformations.

Approaches to the Superior Calix: Renal Displacement Technique and Review of Options

A new percutaneous approach to the superior calix has been implemented with reduced morbidity. To avoid intercostal or retrograde punctures or triangulation methods an Amplatz sheath passed through a central or lower pole calix can be pushed caudally while descent of the kidney is viewed fluoroscopically. An 18-gauge TLA needle passed through the initial skin puncture then is used to form a Y with the original tract. This method has been successful in 21 of 25 cases without complications. The only failures occurred in patients with immobile kidneys secondary to a previous operation.

Percutaneous pyeloplasty (endopyelotomy) for congenital ureteropelvic junction obstruction.

Endopyelotomy was performed in 30 patients with congenital primary ureteropelvic junction obstruction; 4 patients had high insertion of the ureter and 8 patients had caliceal stones. Clinical and radiologic success was achieved in 25 patients. There were five failures, all of whom subsequently had successful open pyeloplasty. The theoretical and experimental foundations of the procedure and fine points of the operative technique are presented. Endopyelotomy appears to be valuable for primary ureteropelvic junction obstruction just as it is for secondary obstruction.

Benefits of Ultrasound-Guided Shock Wave Lithotripsy

Ultrasound has many desirable characteristics for imaging of renal calculi during shock wave lithotripsy. Ultrasound can localize radiolucent stones, monitor fragmentation in real time, and differentiate the stone from a stent. Its use significantly reduces radiation exposure to patient and operator, which is particularly desirable in the pediatric patient. Furthermore, sonography-guided lithotripsy can reveal other pathology in the affected kidney that may require further evaluation. Experience with ultrasound-guided lithotripsy familiarizes the operator with this increasingly useful imaging method. The ultrasound-guided Sonolith 3000 with its enlarged ellipsoid aperture has a smaller energy focus and decreased voltage, permitting fragmentation with reduced anesthesia requirements.

Study of the Aggregation of Calcium Oxalate Crystals Using Shock Wave Lithotripsy

In this study shock wave lithotripsy was investigated as a tool to measure the relative strength of calcium oxalate aggregates. The technique of image analysis was studied for its ability to quantify the degree of calcium oxalate aggregation. Calcium oxalate monohydrate (COM) and calcium oxalate dihydrate (COD) crystals with known morphology were synthesized from supersaturated solutions at 21°C. The COM was conditioned in suspension with bovine serum albumin (BSA) and chondroitin sulfate (CS) at concentrations of 0.1, 0.5, 1.0, and 5.0 ppm. Ten cc aliquots of the suspensions were exposed to either 250 shock waves (SW) or 500 SW from the lithotripter (Technomed Sonolith 2000). Shock wave lithotripsy was found to be useful as a relative measure of aggregate strength of calcium oxalate aggregates and that image analysis was satisfactory as a measure of aggregate size distribution. Preliminary data suggest that in the absence of flocculant (albumin or CS), COD forms stronger aggregates than COM. In addition the data suggest that there is a critical flocculation concentration for albumin and chondroitin sulfate.