Satisfaction with tolterodine: assessing symptom-specific patient-reported goal achievement in the treatment of overactive bladder in female patients (STARGATE study).

AIMS: Open-label study to evaluate the effect of tolterodine extended-release (ER) on symptom-specific patient-reported goal achievement (PGA) of overactive bladder (OAB) symptoms in females.

METHODS: Eligible patients who had frequency >or= 8 and urgency >or= 2 episodes per 24 h with or without urgency incontinence were treated with 12-week tolterodine ER (4 mg once daily). Primary end-point was the rate of PGA by a visual analogue scale compared with initial expectation with treatment. At baseline, patients were asked to set their personal goals for each OAB symptom with treatment. Secondary efficacy variables were changes in symptom severity, voiding diary and patient perception of bladder condition (PPBC), global impression of improvement (GII), and willingness to continue treatment.

RESULTS: A total of 56 patients were entered. The median rate of symptom-specific PGA and reductions in symptom severity were for frequency (60%, 45%), episodes of urgency 60%, 55%), urge incontinence (80%, 71%), nocturia (50%, 52%) and tenesmus (30%, 26%) after 12 weeks treatment. There was a significant improvement in all OAB symptoms in voiding diary. Thirty-five patients (62.5%) experienced an improvement of >or= 2 points in PPBC. Thirty (53.6%) and 22 (39.3%) of patients reported much and little improvement of their symptoms in GII. A total of 41 (73.2%) patients wanted to continue taking the medication at the end of the study.

CONCLUSIONS: Most OAB patients reported improvement of their OAB symptoms with 12-week tolterodine ER 4 mg treatment. There was a significant achievement of symptom-specific goal on the key OAB symptoms. But, PGA did not correlate with objective outcomes.