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Recruiting NCT06855602

CHM for Female Stress Urinary Incontinence

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Plain-language summary for patients

Trial Parameters

Condition Stress Urinary Incontinence (SUI)
Sponsor Hong Kong Baptist University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 15
Sex FEMALE
Min Age 55 Years
Max Age N/A
Start Date 2024-10-21
Completion 2026-03-15
Interventions
Chinese herbal medicine formula (S-2196)

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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.

Eligibility Criteria

Inclusion Criteria: * Females aged ≥55 years * Meet the ICUD diagnostic criteria of stress urinary incontinence * Measured urine leakage \>10g in the 1-hour standard pad test * Understand and can follow written and verbal instructions in Chinese * Able to independently use and complete the electronic diary during the 1-week screening period * The subject is informed and voluntarily signs the informed consent form Exclusion Criteria: * Patients with other types of urinary incontinence, such as neurogenic urinary incontinence, urge urinary incontinence, and overflow urinary incontinence. * Subjects with the following urogenital system diseases (vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract infection or hematuria indicated by routine urinalysis or urine culture, urogenital fistula, urethral diverticulum, bladder stones, urinary system tumors, abnormal vaginal bleeding, pelvic malignant tumors, uterine prolapse grade II or above). * History o

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