Clinical trial NCT04299932: Acupuncture for Stress-predominant Mixed Urinary Incontinence
Official title: Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Urinary Incontinence
Keywords: acupuncture
stress-predominant mixed urinary incontinence
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2020-03-09
Enrollment: 232
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: MUI tends to present with more severe symptoms and put greater burden on the health of individual and economy of society. Current European Association of Urology (EAU) guideline on incontinence recommends to initiate treatment targeted at predominant component of MUI. However, as to whether the interventions for stress urinary incontinence (SUI) can be effectively generalized to stress-predominant MUI, there is still no powerful evidence to support it. It is necessary to seek for interventions specific to stress-predominant MUI. Results of previous studies indicated that acupuncture might help to relieve the incontinence symptoms.

Eligibility criteria: 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 Ⅱ；
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.

Primary outcomes:
measure: Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
timeFrame: week 8
Secondary outcomes:
measure: Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.
timeFrame: week 8
measure: Change of urinary leakage amount from baseline
timeFrame: week 8
measure: Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.
timeFrame: week 4，week 20 and week 32
measure: Change of mean 24-hour IEF from baseline.
timeFrame: week 4，week 8, week 20 and week 32.
measure: Change of mean 24-hour stress IEF from baseline
timeFrame: week 4，week 8, week 20 and week 32.
measure: Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline
timeFrame: week 4，week 8, week 20 and week 32
measure: Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.
timeFrame: week 4，week 8, week 20 and week 32
measure: Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline
timeFrame: week 4，week 8, week 20 and week 32
measure: Change of mean 24-hour pad consumption from baseline
timeFrame: week 4，week 8, week 20 and week 32
measure: Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).
timeFrame: week8, week 20
measure: Change of mean 24-hour urgency episodes from baseline
timeFrame: week 4，week 8, week 20 and week 32
measure: Change of mean 24-hour micturition episodes from baseline
timeFrame: week 4，week 8, week 20 and week 32
Other outcomes:
measure: Participants' expectations of improvement to urinary incontinence
timeFrame: Baseline assessment(week 0)
measure: Participants' belief that acupuncture might help
timeFrame: Baseline assessment(week 0) and week 4.
measure: Safety assessment
timeFrame: Throughout the trial
measure: Blinding assessment
timeFrame: Within 5 minutes after either treatment at week 8
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: The third affiliated hospital of Beijing university of Chinese Medicine
state: Beijing
city: Hengyang
country: China
facility: Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Provincial Hospital of traditional Chinese Medicine
state: Jiangxi
city: Yantai
country: China
facility: Yantai Hospital of Traditional Chinese Medicine
state: Shandong
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: STUDY_CHAIR
References:
citation: Sun Y, Liu Y, Chen H, Yan Y, Liu Z. Electroacupuncture for stress-predominant mixed urinary incontinence: a protocol for a three-armed randomised controlled trial. BMJ Open. 2021 Jan 7;11(1):e038452. doi: 10.1136/bmjopen-2020-038452.