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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Chinese herbal medicine formula (S-2196)
DrugDuring 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
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The 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, week22
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 2Secondary outcomes
1
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 2Other outcomes
1
Safety Outcome: adverse events
All adverse events occur from the beginning of the participant's enrollment to the end of the trial, regardless of whether there is a casual relationship with the received treatments. It will be assessed by the number of adverse events recorded in the patient-reported electronic diary.
Time frame
Baseline, week 2, week 32
Safety Outcome: Heart rate (beats per minute, bpm)
Heart rate will be assessed by a registered Chinese medicine practitioner at each visit to reflect general physical condition safety.
Time frame
Baseline, week 2, week 33
Safety Outcome: Systolic and Diastolic Blood Pressure (millimeters of mercury, mmHg))
Systolic and diastolic blood pressure will be assessed by a registered Chinese medicine practitioner at each visit to monitor blood pressure-related safety.
Time frame
Baseline, Week 2, Week 3Sponsors and contacts
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Source ClinicalTrials.gov