Tolterodine reduces the number of urge incontinence episodes in patients with an overactive bladder.
OBJECTIVE
To evaluate the efficacy, safety and tolerability of tolterodine compared to placebo in patients with an overactive bladder.


METHODS
A double-blind, multi-centre phase III study in France and Belgium 251 patients with overactive bladder symptoms, and urodynamically verified detrusor overactivity, were randomised to receive 4-week treatment with either placebo or tolterodine 1 or 2mg twice daily (bd). Efficacy was evaluated from patient micturition diaries. Safety and tolerability endpoints were also evaluated.


RESULTS
After 4-week treatment, the number of incontinence episodes/24h decreased significantly relative to placebo in the tolterodine 1 and 2 mgbd groups (P=0.045 and P=0.0089, respectively). Both dosages of tolterodine increased volume voided per micturition compared with placebo (P=0.055 and P=0.056, respectively), although significant decreases in micturition frequency were not apparent. Tolterodine was safe and well tolerated, few patients were withdrawn due to adverse events. Dry mouth, mainly of mild-to-moderate intensity, was the most common adverse event. No clinically relevant changes in blood pressure or laboratory safety variables were reported.


CONCLUSIONS
Tolterodine is effective, safe and well tolerated for the treatment of symptoms of an overactive bladder, particularly urge incontinence.
Jacquetin
B
B
Urogynaecology Unit, Hôtel Dieu Maternité, CHU, BP 69-63003 Cedex 1, Clermont-Ferrand, France. bjacquetin@chu-clermont.fr
Wyndaele
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001530:Belgium; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003408:Cresols / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D010665:Phenylpropanolamine; D010919:Placebos; D000068737:Tolterodine Tartrate; D001745:Urinary Bladder Diseases / Q000150:complications* / Q000188:drug therapy; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000209:etiology; D014554:Urination; D014556:Urine
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010919:Placebos; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate