Mixed Urinary Incontinence Clinical Trial
Official title:
Electroacupuncture for Women With Mixed Urinary Incontinence: a Sham-controlled Randomised Clinical Trial
The investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (EA), compared with sham electroacupuncture (SA) on women with mixed urinary incontinence (MUI).
Status | Not yet recruiting |
Enrollment | 222 |
Est. completion date | December 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 75 Years |
Eligibility | Inclusion Criteria: - Female, 35 to 75 years old - Diagnosed as mixed urinary incontinence - Positive in cough stress test - Experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening - Sign the informed consent form Exclusion Criteria: - Diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc. - Uncontrolled urinary tract infection with urinary pain and urge - Urogenital system tumours and/or pelvic organ tumours - Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month - History of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; Patients have pelvic organ prolapse = II degree - Residual urine = 100ml - Uncontrolled diabetes mellitus and severe hypertension - Diseases affecting lower urinary tract function - Severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction - Constrained or unable to complete movements like walking, going stairs up and down and running, etc. - At pregnancy, breastfeeding or postpartum period for less than 12 months - Cardiac pacemaker, metal allergy or strong fear of needle - Patients have received acupuncture in the past 3 months |
Country | Name | City | State |
---|---|---|---|
China | Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Shi Hangyu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes. | 72-hour incontinence episodes dairy | week 8 | |
Secondary | the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes | 72-hour incontinence episodes dairy | week 4, 20, 32 | |
Secondary | the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes | 72-hour incontinence episodes dairy | week 4, 8, 20, 32 | |
Secondary | the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes | 72-hour incontinence episodes dairy | week 4, 8, 20, 32 | |
Secondary | the change from baseline in the amount of urine leakage measured by the 1-hour pad test | 1-hour pad test | baseline, week 8 | |
Secondary | the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores | data will be collected via International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF). The total score(0-21scores) is an accumulated scores from question 1 to 3. The higher the total score is, the severer the incontinence is. | week 4, 8, 20, 32 | |
Secondary | the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores | data will be collected via the Overactive Bladder Questionnaire-Short Form (0-15 scores). The higher the total score is, the severer the condition is. | week 4, 8, 20, 32 | |
Secondary | incidence rate of any adverse events | adverse event will be documented as soon as it is reported during treatments and follow-ups | up to 32 weeks | |
Secondary | patients' expectation to treatment | patients will be asked about their expected effect of the treatment via question: In your expectation, how is your incontinence like in a two month time. Five choices will be provided 1) much better; 2) slightly better; 3) I don't know; 4) no change; 5) worse. | baseline | |
Secondary | blinding assessment | patients will be asked whether they received electroacupuncture or sham electroacupuncture | week 8 |
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