Mixed Urinary Incontinence Clinical Trial
Official title:
Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
The investigators plan to conduct this multi-center, three-armed, randomized controlled trial to evaluate the efficacy of electroacupuncture (EA), compared with sham electroacupuncture (SA) and waiting list (WL) on participants with stress-predominant mixed urinary incontinence (MUI).
Status | Recruiting |
Enrollment | 232 |
Est. completion date | September 30, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline; 2. Female participants aged between 35 and 75; 3. Stress index > urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire; 4. Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary; 5. Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary; 6. Positive cough stress test; 7. Urine leakage > 1 g in 1-hour pad test; 8. Voluntary participation in the trial and signed written informed content. Exclusion Criteria: 1. Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder; 2. Uncontrolled symptomatic urinary tack infection; 3. Tumor in urinary system and pelvic organ; 4. Pelvic organ prolapse = degree ?; 5. Residual urine volume = 100ml; 6. History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month; 7. History of surgery targeted at UI or in pelvic floor, including hysterectomy; 8. Uncontrolled diabetes or severe high blood pressure; 9. Nervous system diseases that may hamper the function of urinary system, such as Multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina nerve injury, or multiple system atrophy; 10. Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction 11. Installed cardiac pacemaker; 12. Inconvenient or unable to walk, run, go up and down stairs; 13. Allergy to metal, severely fear of acupuncture needles or unbearable to EA; 14. Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth. |
Country | Name | City | State |
---|---|---|---|
China | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Beijing | Beijing |
China | The third affiliated hospital of Beijing university of Chinese Medicine | Beijing | Beijing |
China | Hengyang Hospital Affiliated to Hunan University of Chinese Medicine | Hengyang | Hunan |
China | Jiangxi Provincial Hospital of traditional Chinese Medicine | Nanchang | Jiangxi |
China | Yantai Hospital of Traditional Chinese Medicine | Yantai | Shandong |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Ministry of Science and Technology of the People´s Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participants' expectations of improvement to urinary incontinence | Participants in the three groups will be asked: How do you expect your urinary incontinence to be in two months? Participants will choose the answer form the following options: Much better; Better; Don't know; Same; Worse; | Baseline assessment(week 0) | |
Other | Participants' belief that acupuncture might help | In EA and SA groups, participants will be asked the question: Do you think your incontinence problem may be helped by acupuncture? Participants will choose the answer from the following options: Very ineffective; Fairly ineffective; Can't decide; Effective; Very effective; | Baseline assessment(week 0) and week 4. | |
Other | Safety assessment | Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not. | Throughout the trial | |
Other | Blinding assessment | Participants in both EA and SA groups will be asked the question: do you think you have received EA? Participants will choose the answer between the options of Yes or No. | Within 5 minutes after either treatment at week 8 | |
Primary | Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline. | The stress IEF will be documented in 3-day voiding diary. | week 8 | |
Secondary | Proportion of participants with at least 50% reduction of urinary leakage amount from baseline. | The urinary leakage amount will be measured by 1 hour pad test. | week 8 | |
Secondary | Change of urinary leakage amount from baseline | The urinary leakage amount will be measured by 1 hour pad test. | week 8 | |
Secondary | Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline. | The stress IEF will be documented in 3-day voiding diary. | week 4,week 20 and week 32 | |
Secondary | Change of mean 24-hour IEF from baseline. | The IEF will be documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32. | |
Secondary | Change of mean 24-hour stress IEF from baseline | The stress IEF is documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32. | |
Secondary | Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline | The IEF will be documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32 | |
Secondary | Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline. | ICIQ-SF questionnaire is a validated questionnaire to assess the severity of incontinence symptoms and influence on QoL in the past four weeks. The questionnaire includes items of IEF, urinary leakage amount and general influence on life to be scored. Total number of the score ranges from 1 to 21, with higher scores representing greater severity and 2.52 as minimal clinically important differences. | week 4,week 8, week 20 and week 32 | |
Secondary | Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline | OAB-q SF is a validated questionnaire used to assess the OAB symptom bother and the health-related quality of life (HRQL) in the past 4 weeks. The domains include coping, concern, sleep and emotional interactions. The scores are transformed to a 0- to 100-point scale, with higher scores indicating severe symptoms and better HRQL. | week 4,week 8, week 20 and week 32 | |
Secondary | Change of mean 24-hour pad consumption from baseline | The pad consumption will be documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32 | |
Secondary | Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I). | PGI-I is a global index, with only one item, used to rate the participants' subject perception on symptom improvement. Participants will describe their impression from very much better to very much worse. Adequate Improvement is defined as the response of"much better" or "very much better". | week8, week 20 | |
Secondary | Change of mean 24-hour urgency episodes from baseline | The urgency episodes will be documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32 | |
Secondary | Change of mean 24-hour micturition episodes from baseline | The micturition episodes will be documented in 3-day voiding diary. | week 4,week 8, week 20 and week 32 |
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