Effect of tolterodine extended release with or without tamsulosin on measures of urgency and patient reported outcomes in men with lower urinary tract symptoms.

ABSTRACT

PURPOSE: We evaluated the efficacy of tolterodine extended release and/or tamsulosin on micturition related urgency episodes, urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials. MATERIALS AND METHODS: Men 40 years old or older with an International Prostate Symptom Score of 12 or greater, frequency (8 or more voids per 24 hours) and urgency (3 or more episodes per 24 hours) with or without urgency urinary incontinence were randomized to placebo, 4 mg tolterodine extended release, 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin for 12 weeks. Subjects completed 5-day diaries; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline, and weeks 1, 6 and 12; Overactive Bladder Questionnaire at baseline, and weeks 6 and 12; Perception of Treatment Satisfaction question at weeks 1, 6 and 12; and Willingness to Continue question at week 12. Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater. Urgency severity was measured using frequency-urgency sum, defined as the sum of urgency ratings for all micturitions. RESULTS: Compared with placebo, tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1, 6 and 12. It also improved Patient Perception of Bladder Condition scores at weeks 1, 6 and 12; improved Urgency Perception Scale and Overactive Bladder Questionnaire, Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12, and willingness to continue at week 12. CONCLUSIONS: Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials.