Attention: Restrictions on use of AUA, AUAER, and UCF content in third party applications, including artificial intelligence technologies, such as large language models and generative AI.
You are prohibited from using or uploading content you accessed through this website into external applications, bots, software, or websites, including those using artificial intelligence technologies and infrastructure, including deep learning, machine learning and large language models and generative AI.

JU INSIGHT Efficacy and Safety of TAS-303 in Female Patients With Stress Urinary Incontinence

By: Satoru Takahashi, MD, PhD, Nihon University School of Medicine, Tokyo, Japan; Kumiko Kato, MD, PhD, Meitetsu Hospital, Nagoya, Japan; Osamu Yokoyama, MD, PhD, Harue Hospital, Sakai, Japan; Mineo Takei, MD, PhD, Harasanshin Hospital, Fukuoka, Japan; Momokazu Gotoh, MD, PhD, Japan Community Health Care Organization, Chukyo Hospital, Nagoya; Australia | Posted on: 14 Aug 2024

Takahashi S, Kato K, Yokoyama O, Takei M, Gotoh M. Efficacy and safety of TAS-303 in female patients with stress urinary incontinence: a phase 2, randomized, double-blind, placebo-controlled trial. J Urol. 2024;212(2):267-279. doi:10.1097/JU.0000000000004024

Study Need and Importance

Stress urinary incontinence (SUI) commonly affects women, causing urine leakage during effort/physical exertion, coughing, or sneezing. Current treatments include nonsurgical methods (eg, pelvic floor muscle training) and surgical options (eg, midurethral slings), yet pharmacological treatments are limited. TAS-303, a selective noradrenaline reuptake inhibitor, shows promise in increasing urethral pressure. Early studies indicate its potential efficacy, but further research is needed. This study evaluates the effectiveness and safety of once-daily 18 mg TAS-303 compared to placebo in Japanese women with SUI over 12 weeks.

What We Found

A total of 220 patients were enrolled in the per-protocol set (TAS-303 n = 109 and placebo n = 111). TAS-303 demonstrated superior efficacy over placebo at Week 12, reducing SUI episodes by 57.7%, compared to 46.9% with placebo (P = .036). TAS-303 also showed improvement in incontinence frequency, amount, and quality of life, especially in patients with ≥ 2 SUI episodes daily at baseline. Adverse events with TAS-303 were mild or moderate, with no serious or discontinuation-related events. No nervous system– or gastrointestinal-related (eg, nausea or vomiting) adverse reactions occurred (Figure).

Image

Figure. Percent change in mean stress urinary incontinence episode frequency (SUIEF) from baseline to Week 12 in the treatment period in the per-protocol set (N = 221). Analysis Set: per-protocol set. *Indicates P = .036 (analysis of covariance, where fixed effects are treatment group and 24-hour pad test). LS indicates least squares.

Limitations

The limitations of this study were its exploratory design, the inclusion of only Japanese patients, its small sample size, the large placebo effect, and low urinary incontinence volume. The relatively small study population may have led to the lack of significance observed for between-group differences for subjective measures, such as Patient Global Impression of Improvement and Incontinence Quality of Life questionnaires. Lastly, although the definition of severe incontinence episode frequency per 24 hours is not generalized, the baseline amount of SUI (based on 24-hour pad test) was considered to be mild for all patients.

Interpretation for Patient Care

Our study shows that TAS-303 demonstrated superior efficacy to placebo for the treatment of SUI in Japanese women, with an adequate safety profile. TAS-303 may serve as an effective and safe drug treatment option for women with SUI.

advertisement

advertisement