CHM for Female Stress Urinary Incontinence
ConditionStress Urinary Incontinence (SUI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55+
SponsorHong Kong Baptist University
About this trial
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
Qualifiers
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
Disqualifiers
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 of SUI surgery or complex urethral surgery, including previous transvaginal tension-free mid-urethral sling, anterior wall prolapse repair, urethral injection therapy, etc.
Previous pelvic radiotherapy, radical surgery for pelvic malignant tumors, and pelvic floor surgery.
Trial design
Treatments tested in this trial
- Chinese herbal medicine formula (S-2196)
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov