Tolterodine and Tamsulosin for Treatment of Men With Lower Urinary Tract Symptoms and Overactive Bladder

• DOI: 10.1001/jama.296.19.2319
• Publication Date: 2006-11-14T11:02:57Z
• Authors: Steven A. Kaplan; Claus G. Roehrborn; Eric S. Rovner; Martin Carlsson; Tamara Bavendam; Zhonghong Guan
• Keywords: Tolterodine; Tamsulosin; Tolerability; Urination

Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy antimuscarinic agents or alpha-receptor antagonists.To evaluate the efficacy safety of tolterodine extended release (ER), tamsulosin, both in men who met research criteria for benign prostatic hyperplasia.Randomized, double-blind, placebo-controlled trial conducted at 95 urology clinics United States involving 40 years older had a total International Prostate Symptom Score 12 higher and, an quality-of-life (QOL) item score 3 higher, self-rated condition least moderate bother, diary documenting micturition frequency (>or=8 micturitions per 24 hours) urgency (>or=3 episodes hours), without incontinence. Patients were recruited between November 2004 February 2006, study was completed May 2006.Patients randomly assigned receive placebo (n = 222), 4 mg ER 217), 0.4 tamsulosin 215), plus 225) weeks.Patient perception treatment benefit, variables, Scores, tolerability assessed.A 172 (80%) receiving reported benefit by week compared 132 patients (62%) (P<.001), 146 (71%) (P=.06 vs placebo), 135 (65%) (P=.48 placebo). experienced significant reductions incontinence (-0.88 -0.31, P=.005), (-3.33 -2.54, P=.03), hours (-2.54 -1.41, P<.001), night (-0.59 -0.39, P.02). demonstrated improvements on (-8.02 placebo, -6.19, P=.003) QOL (-1.61 -1.17, P=.003). All interventions well tolerated. The incidence acute retention requiring catheterization low (tolterodine 0.4%; ER, 0.5%; 0%; 0%).These results suggest that weeks provides severe including bladder. Clinical Trials Registration clinicaltrials.gov Identifier: NCT00147654.