American Urological Association: Extended-Release Muscarinic Agonist (Tolterodine) for Overactive Bladder

In: Disease

14 May 2010

TolterodineSpeaker: Jay M. Young, MD, Medical Director, South Orange County Medical Research Center, Laguna Woods, California.

Patients with overactive bladder who received extended-release (ER) tolterodine tartrate (LA, Pharmacia) experienced significantly improved perceptions of urinary urgency and bladder condition, compared with patients who took placebo.

To fully evaluate the benefits, investigators randomly assigned 1,015 patients with urinary frequency (defined as more than eight micturitions every 24 hours) and incontinence (defined as more than five episodes per week) to receive tolterodine ER 4 mg or placebo once daily for 12 weeks. A three-point ordered categorical scale was used to assess patients’ perceptions of urgency and blad­der condition at the baseline evaluation, and a six-point scale was used to assess their perceptions at the 12th week.

At 12 weeks, 198 patients (39%) taking tolterodine ER and 132 patients (25%) taking placebo reported improved perceptions of urgency. The percentage of patients who reported that they were able to complete a task before needing to void rose from 6% to 30%—a fivefold increase—in the patients given tolterodine ER compared with a difference from 7% to 16%—a two-fold increase—in the placebo group. The number of patients who reported that they were unable to hold their urine declined by 54% in the tolterodine treated group and by 27% in the placebo group. In the canadian tolterodine group, 58% of patients had improved perceptions of their bladder condition, compared with 43% of the patients who received placebo.

Solifenacin, an Oral Antimuscarinic Agent for Overactive Bladder

Speaker: Paul F. Siami, MD, Medical Director, Wellborn Clinic, Evansville, Indiana.

In multiple trials, solifenacin succinate (Vesicare®, Yaman-ouchi), a new once-daily, oral selective muscarine receptor antagonist, provided statistically significant reductions in quantified urgency episodes in patients with overactive bladder. This is the first antimuscarinic agent for which such results have been reported.

These conclusions were reached from the pooled data of four 12-week, randomized, placebo-controlled phase 3 clinical trials that assessed the efficacy, safety, and tolerability of solifenacin in 3,032 patients. The patients were randomly selected to receive treatment, and 2,848 patients were available for statistical analysis. Of this latter group of patients, 2,823 individuals reported urgency at the baseline evaluation; 1,124 received placebo; 548 received solifenacin 5 mg; and 1,151 received solifenacin 10 mg. This group of patients, encompassing all three treatments, had a mean of 5.9 to 6.3 urgency episodes a day and approximately 12 micturitions per day.

Statistically significant reductions of 50% or more in the mean number of daily urgency episodes were reported by 62% of patients taking solifenacin 5 mg, by 66% of those taking solifenacin 10 mg, and by 44% of those taking placebo, compared with concentrations of whichever study drug was used. The changes from baseline to endpoint in the mean number of urgency episodes per 24 hours were -2.9 for patients taking solifenacin 5 mg, -3.4 for those taking solifenacin 10 mg, and -2.0 for those taking placebo.

Most of the anticholinergic side effects were classified as mild to moderate. The most commonly reported ADE was dry mouth, reported by 28% of patients receiving solifenacin 10 mg, by 11% of those receiving solifenacin 5 mg, and by 4% of those receiving placebo.

FloSeal® Gelatin Matrix for Tubeless Percutaneous Nephrolithotomy

Speaker: Isaac Kim, MD, Clinical Endourology Fellow and Clinical Instructor in Laparoscopic and Endourologic Procedures, Department of Urology, University of California at Irvine, Medical Center, Irvine, California.
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Following successful percutaneous nephrolithotomy (PCNL), a high-viscosity hemostatic gelatin matrix (FloSeal® Matrix Hemostatic Sealant, Baxter), achieved rapid hemo-stasis and sealing of the nephrostomy tract. This sealant, which is composed of a combination of specially engineered collagen-derived particles and topical thrombin, negated the need for tube or suture placement and helped to shorten the length of hospitalization.

Eight patients who were treated with FloSeal® were compared with eight patients who underwent single-access, standard PCNL. In the FloSeal®-treated patients, after fluoros-copy and endoscopy confirmed that the patients were free of stones, a 260-cm exchange guide wire was passed through the urethra and was retrieved through the flank. An occlusion balloon catheter was passed into the collecting system, and the balloon was inflated under endoscopic control until it occluded entry into the renal collecting system. A syringe of FloSeal® with a laparoscopic applicator was injected while the applicator and the nephrostomy sheath were removed together simultaneously. A Foley catheter was placed, and the skin closed with a topical adhesive, 2-octyl cyanoacrylate (Derma-bond, Ethicon, Johnson & Johnson). The Foley catheter was removed the next morning.
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Preoperative, intraoperative, and postoperative results were compared in the two treatment groups of patients. Intra-operative and postoperative findings were similar with regard to operative time, estimated blood loss, change in hematocrit values, and analog pain score. The FloSeal® patients tended to have shorter hospital stays (29 hours) than the patients in the standard PCNL group (49 hours).

A randomized, prospective trial is planned.

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