(HealthDay News) — Once-daily TAS-303 is superior to placebo for treatment of stress urinary incontinence (SUI) in women, according to a study published in the August issue of The Journal of Urology.
Satoru Takahashi, MD, PhD, from Nihon University School of Medicine in Tokyo, and colleagues conducted a double-blind phase 2 study involving women with SUI symptoms who were randomly allocated to receive once-daily oral administration of TAS-303 18 mg or placebo for 12 weeks (116 and 115 patients, respectively). The percent change from baseline to week 12 in mean SUI episode frequency per 24 hours (SUIEF) was examined in the per-protocol set as the primary end point.
The researchers found that TAS-303 had superior efficacy to placebo at week 12, with a least squares mean percentage change in mean SUIEF of −57.7 versus −46.9%, respectively, in the per-protocol set. In the full analysis set, some evidence of improved incontinence episode frequency, incontinence amount and health-related quality of life was seen at week 12 for TAS-303 versus placebo. In patients with two or more SUI episodes daily at baseline, the between-group difference in SUIEF improvement was more clearly confirmed. All adverse events with TAS-303 were mild or moderate.
“Further validation studies in larger more diverse populations are needed to confirm the efficacy and safety of TAS-303 in women with SUI,” the authors write.
Several authors disclosed ties to pharmaceutical companies, including Taiho Pharmaceuticals, which is developing TAS-303 and funded the study.
