Tolterodine: a safe and effective treatment for older patients with overactive bladder.
OBJECTIVE
To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder.


METHODS
Randomized, double-blind, placebo-controlled, parallel-group, multinational, phase III study.


METHODS
Incontinence, older care, urological, and urogynecological clinics in the United Kingdom, France, and the Republic of Ireland.


METHODS
One hundred and seventy-seven older patients (age > or =65 years) with symptoms of urinary urgency, increased frequency of micturition (> or =8 micturitions/24 hours), and/or urge incontinence (> or =1 episode/24 hours).


METHODS
Tolterodine 1 mg or 2 mg twice daily (bid), or placebo, for 4 weeks.


METHODS
Safety and tolerability were evaluated through spontaneously reported adverse events, electrocardiogram, and blood pressure measurements. Efficacy was assessed using micturition diary variables: mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours.


RESULTS
The mean age of the patient population was 75 years. Overall, > or =87% of patients completed the study. Neither dosage of tolterodine was associated with serious drug-related adverse events during the study. No cardiac arrythmogenic events were noted. Dry mouth (mild to moderate intensity) was the most common adverse event in both the placebo and tolterodine treatment groups. Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth, compared with 2% of placebo-treated patients. Compared with placebo, statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups. Furthermore, patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo.


CONCLUSIONS
Tolterodine (taken for 4 weeks) is safe and shows efficacy, particularly at a dosage of 2 mg bid, in the treatment of older patients with urinary symptoms attributable to overactive bladder.
Malone-Lee
J G
JG
Department of Medicine, Whittington Hospital, Royal Free and University College Medical School, London, Great Britain.
Walsh
J B
JB
Maugourd
M F
MF
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000494:pharmacology / Q000627:therapeutic use*; D003408:Cresols / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D010665:Phenylpropanolamine; D010919:Placebos; D012449:Safety; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014555:Urination Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014987:Xerostomia / Q000139:chemically induced
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010919:Placebos; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate