Efficacy and safety of Solifenacin in the treatment of patients with urgency and urge incontinence WU

Abstract

Objective To evaluate the efficacy and safety of Solifenacin in patients with urinary urgency and urgy incontinence. Methods Two hundred and forty-six patients with urgency and urgy incontinence who had symptoms of overactive bladder(OAB) for ≥3 months were enrolled. A double-blind double-dummy randomized controlled multicenter clinical trial was conducted, Patients were ran-domized into 2 groups. One hundred and twenty-three patients (17 males, 106 females) received Soli-fenacin (5 mg once daily) whose median urgency episodes were 4.33. The other 123 patients (26 males, 97 females) received Tolterodine (2 mg twice daily) whose median urgency episodes were 4.00. After 8 weeks' treatment, all patiens recorded the 3-day diary repeatedly and the adverse events as well. The results of the efficacy and safety were analyzed by using SAS V8.2. Results After 8 week treatment, the median decreases of urgency episodes were both 3.00(P<0.01), there was no significant difference between the 2 groups (P=0.58). The median decreases of urge incontinence epi-sodes were 1.00 (P<0.01) and 0.67 (P=0.05), there was no significant difference between the 2 groups (P=0.29). That of nocturia, the decreases were 0.74(P<0.01) and 0.68 (P<0.01), there also was no significant difference between the 2 groups (P=0.73). In addition, the mean decreases of number of micturition were 2.79 and 2.47, and the mean increases of volume voids were 29.53 ml and 23.04 ml, there were no significant differences between the 2 groups (P=0.54, P=0.29). The total incidences of treatment-emergent adverse events (AEs) were 11.7 % (14/120) in the Solifenacin group and 23.5% (27/115) in the Tolterodine group (P<0.05). The most frequently reported AE was dry mouth, the frequency was lower among patients receiving Solifenacin 5.8% compared to those recei-ving Tolterodine 10.4%(P<0.05). Conclusion Solifenacin could be the safer and effective drug in the treatment of OAB patients with main complaints of urinary urgency and urgy incontinence. Key words: Urgency; Solifenacin; Clinical trial