Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT06855602
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CHM for Female Stress Urinary Incontinence
Sponsor:
Hong Kong Baptist University
Organization:
Study Overview
Official Title:
A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (S-2196) for the Female Stress Urinary Incontinence (SUI)
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: