Clinical efficacy and safety of tolterodine compared to placebo in detrusor overactivity

Purpose: We evaluated the efficacy, patient;acceptability and side effect p rofile of tolterodine, a new antimuscarinic agent for treating bladder over activity. Materials and Methods: In our randomized, placebo controlled, parallel grou p study 123, 129 and 64 patients 18 years old or older with proved detrusor overactivity (idiopathic detrusor instability or detrusor hyperreflexia) w ere randomized to receive 1 or 2 mg. tolterodine, or placebo, respectively, twice daily for 12 weeks. Main outcome measures were number of voids per 2 4 hours, urine volume per void and episodes of urge incontinence per 24 hou rs on a frequency-volume chart with detailed recording of side effects. Results: After 12 weeks of treatment mean number of voids per 24 hours plus or minus standard deviation decreased from 11.2 +/- 3.1. to 9.0 +/- 2.6 wi th the 2 mg. dosage (p = 0.0045 versus placebo). At this dose mean urine vo lume per void increased from 155 +/- 52 to 190 +/- 70 mi. (p <0.0001 versus placebo), while mean number of incontinence episodes per 24 hours decrease d from 3.6 +/- 4.0 to 1.8 +/- 3.1 (p = 0.19 versus placebo). Similar effica cy was observed in patients receiving the 1 mg. dose. Severe dry mouth was reported by only 2, 1 and 2% of patients given the 1 and 2 mg. dose, and pl acebo, respectively. There was no clinical or electrocardiographic evidence of significant cardiac adverse events. Conclusions: Tolterodine administration resulted in a significant decrease in the frequency of voiding and improved voided volume but it was seldom as sociated with troublesome or severe side effects.