The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
People's Hospital of Peking University
Beijing, Beijing Municipality, China
the percent change in the urinary incontinence volume measured in a 1-hour pad test
Time frame: Baseline, week 12
The percent change in urinary incontinence volume measured in a 24-hour pad test
Time frame: Baseline, week 12
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test
Time frame: Baseline, week 8 week20
The average urinary incontinence episode frequency per 24 hours
Time frame: Baseline, week 8, week 12, week20
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time frame: Baseline, week 8, week 12,week20
The change in UDI-6 scores
Time frame: Baseline, week 8, week 12,week20
The change in PISQ-6 scores
Time frame: Baseline, week 8, week 12,week20
Incidence of adverse events and side effects
Time frame: Up to 20 Weeks
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