Phase 2
N=256
Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT02906683 ↗Enrolled (actual)
256
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 — 2.9; 2.5; 2.6; 2.0 episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TAS-303 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 |
2.9; 2.5; 2.6; 2.0; 1.7; 1.9 | — |
| PRIMARY Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 |
-34.7; -35.4; -28.1 | 0.329 |
| SECONDARY Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 |
2.9; 2.5; 2.6; 2.3; 2.0; 2.2 | — |
| SECONDARY Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 |
-23.1; -23.9; -11.7 | 0.082 |
| SECONDARY Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup |
2.7; 2.5; 2.6; 2.0; 1.9; 2.3 | — |
| SECONDARY Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup |
-26.5; -25.8; -8.9 | 0.019 sig |
| SECONDARY Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup |
2.7; 2.5; 2.6; 1.8; 1.8; 2.0 | — |
| SECONDARY Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup |
-37.4; -35.7; -26.1 | 0.125 |
| SECONDARY Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period |
25; 27; 13 | — |
| SECONDARY Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8 |
28; 29; 26; 49; 58; 44 | — |
| SECONDARY Any Adverse Events |
31; 20; 26; 1; 0; 0 | — |
| SECONDARY Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period |
9; 4; 8; 2; 0; 1 | — |
| SECONDARY Adverse Drug Reactions |
6; 0; 0; 1; 0; 0 | — |
| SECONDARY Serious Adverse Events |
0; 0; 0 | — |
| SECONDARY Adverse Events Leading to Discontinuation of Administration |
0; 1; 0; 0; 1; 0 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Eligibility Criteria
Inclusion Criteria
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
- Patient is positive in 1-hour pad weight test
Exclusion Criteria
- Patient has predominant or primary urge incontinence according to investigator judgment
- Patient had a prior surgical SUI treatment
- Patient is diagnosed stageII or more of Pelvic Organ Prolapse
- Patient has symptoms of Urinary tract infection (UTI)
- Patient is positive pregnancy test
- Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
Data sourced from ClinicalTrials.gov (NCT02906683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.