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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.
- Source :
- International Journal of Urology; Jan2021, Vol. 28 Issue 1, p82-90, 9p
- Publication Year :
- 2021
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09198172
- Volume :
- 28
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- International Journal of Urology
- Publication Type :
- Academic Journal
- Accession number :
- 148069324
- Full Text :
- https://doi.org/10.1111/iju.14411