A multicenter, prospective, open-label study of tolterodine extended-release 4 mg for overactive bladder: the speed of onset of therapeutic assessment trial (STAT).

BACKGROUND

Antimuscarinic agents are the primary treatment for overactive bladder (OAB), but there is a lack of information regarding when maximum symptom relief and maximum perceived patient benefit occur.

OBJECTIVE

This study assessed the speed of onset of therapeutic benefit with tolterodine extended-release (ER) 4 mg.

METHODS

This 12-week, multicenter, prospective, open-label study enrolled patients with OAB who either had received no previous pharmacologic treatment for OAB (drug naive) or were receiving such treatment at enrollment (previously treated). Efficacy was assessed at 1, 4, and 12 weeks using a micturition diary and measures of patients' and physicians' perceptions of improvement. Safety was assessed in terms of adverse events and study withdrawals.

RESULTS

The intent-to-treat population included 1138 patients (302 men, 836 women; 88.4% white; age range, 18-91 years), 735 drug naive and 403 receiving treatment for OAB at enrollment. After 1 week, tolterodine ER 4 mg had produced a significant improvement in all efficacy variables in both groups of patients (P < 0.01); 72% of the maximum effect on urge incontinence was observed in both groups; and 84.7% of drug-naive patients and 83.6% of previously treated patients perceived a benefit from treatment. After 4 weeks, drug-naive and previously treated patients reported a respective 93% and 100% of the maximum effect on episodes of urge incontinence. Tolterodine was well tolerated, with dry mouth (mostly mild) the most commonly reported adverse event (15.5% in each group). The 330 (81.9%) patients who had reported unacceptable efficacy and the 87 (21.6%) patients who had reported unacceptable tolerability of previous OAB treatment responded favorably to tolterodine ER 4 mg.

CONCLUSIONS

Tolterodine ER 4 mg was effective and well tolerated in both drug-naive and previously treated patients with OAB. More than 80% of patients reported benefit from treatment after 1 week, but maximum symptom relief was achieved with longer treatment.