This single-arm, open-label pilot clinical trial will test the hypothesis that S-2196, a Chinese herbal medicine formula, will show efficacy and safety in alleviating the amount and frequency of urinary incontinence in female individuals with stress urinary incontinence. All participants (n=15) will receive 1 week of screening, 2 weeks of intervention, and 1 week of follow-up.
Purpose of the Study: This clinical study aims to observe the efficacy and safety of treating stress urinary incontinence in females using the Chinese herbal medicine formula S-2196. Study Design: Single-arm, open-label, pilot trial. Target Population: Female patients aged 55 years and above who meet the clinical diagnostic criteria for SUI set by the International Consultation on Urological Diseases (ICUD); and with the amount of urinary leakage \>10g in the 1-hour pad test; capable of understanding and using Chinese; and have signed the informed consent form. Sample Size: This clinical trial is an exploratory pilot study with an estimated sample size of 15 participants. Treatment Plan: Participants will take the Chinese herbal medicine formula decoction for two weeks, twice a day, 150 milliliters each time, after meals. Primary Outcome: 1. Change in the amount of urinary leakage in the 1-hour standard pad test, compared to baseline (Time point: after 2 weeks of treatment); 2. Change in average daily frequency of urinary incontinence episode, compared to baseline (Time point: after 2 weeks of treatment) Secondary Outcome: Change in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, compared to baseline (Time point: after 2 weeks of treatment) Safety Outcomes: 1. Any adverse reaction symptoms/adverse events occurring after the trial treatment. 2. General physical examination items (including heart rate, blood pressure, etc.) Statistical Analysis: The database is constructed using REDCap, and all statistics are analyzed using SPSS version 23 statistical analysis software, to analyze the general conditions, demographic and other baseline characteristics, compliance, efficacy, and safety of the participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
During the 2-week intervention, all participants are required to take 150ml of S-2196 decoction (a Chinese herbal medicine formula containing four herbs) twice per day
Hong Kong Baptist University
Hong Kong, Hong Kong
RECRUITINGThe change in the amount of urine leakage during the 1-hour standard pad test compared to the baseline (time point: the end of the 2nd week of treatment)
The measurement of leakage volume follows the standardized 1-hour pad test protocol by the International Continence Society (ICS). The procedure includes the following steps: (1) Participants are required to void their bladder 2 hours before the test. (2) Upon start, participants will wear a pre-weighed pad and are instructed to drink 500 milliliters of water within 15 minutes. (3) Participants will walk for 30 minutes, including walking up and down one flight of stairs. (4) Participants will perform the following activities during the remaining time: sit down and stand up 10 times, cough vigorously 10 times, run in place for 1 minute, bend down to pick up an object from the floor 5 times, and wash hands under running water for 1 minute. (5)After completing these activities, the pad will be weighed again to calculate the leakage volume. 1g \< leakage volume ≤ 10g is classified as mild; 10g \< leakage volume ≤ 50g is classified as moderate; leakage volume \> 50g is defined as severe.
Time frame: Baseline, week2
The change in the average daily frequency of urinary incontinence episode compared to the baseline (time point: the end of the 2nd week of treatment).
The average daily frequency of urinary incontinence episodes (IEF) is calculated based on the number of incidences of urinary incontinence within a continuous 24-hour period, as recorded in the patient-reported electronic bladder diaries.
Time frame: Baseline, week 2
The Change in International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score compared to baseline (Time point: after 2 weeks of treatment)
The ICIQ-SF is a questionnaire strongly recommended by the International Continence Society (ICS) for assessing stress urinary incontinence (SUI). It includes three questions regarding the frequency of incontinence, the amount of leakage, and the impact on daily life. The total score ranges from 0 to 21, with lower scores indicating less severe SUI.
Time frame: Baseline, week 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.