Efficacy and safety of the noradrenaline reuptake inhibitor, TAS‐303, in women with stress urinary incontinence: Results of a double‐blind, randomized, placebo‐controlled, early phase II trial

Objective To carry out an exploratory assessment of the efficacy and safety of TAS‐303, a noradrenaline reuptake inhibitor, in women with stress urinary incontinence. Methods In a double‐blind, placebo‐controlled, early phase II study, women with stress urinary incontinence and stress urinary incontinence‐predominant mixed urinary incontinence were randomized to a placebo or TAS‐303 (3 or 6 mg) once daily for 8 weeks. The main efficacy end‐points were mean percentage change in incontinence episode frequency per 24 h from baseline to week 8 (the primary end‐point) and week 4. Results At week 8, the mean percentage change in incontinence episode frequency per 24 h was −34.73% in the TAS‐303 3 mg group, −35.41% in the TAS‐303 6 mg group and −28.07% in the placebo group (differences vs placebo, not significant). In patients with stress urinary incontinence, or incontinence episode frequency less than two episodes per 24 h at baseline, TAS‐303 significantly reduced incontinence episode frequency versus placebo after 4 weeks; some secondary end‐points also showed a tendency to improve in the same subgroups. No serious adverse events (e.g. central nervous system or cardiovascular effects) were observed; TAS‐303 was well tolerated and had a favorable safety profile. Conclusion These findings suggest that TAS‐303 is effective for improving stress urinary incontinence symptoms in some subgroups of patients with stress urinary incontinence. Therefore, further research is warranted.