Acupuncture for Stress-predominant Mixed Urinary Incontinence
Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial
1 other identifier
interventional
232
1 country
5
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2020
CompletedFirst Posted
Study publicly available on registry
March 9, 2020
CompletedStudy Start
First participant enrolled
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedJanuary 6, 2021
January 1, 2021
2.5 years
March 5, 2020
January 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.
week 8
Change of urinary leakage amount from baseline
week 8
Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.
week 4，week 20 and week 32
Change of mean 24-hour IEF from baseline.
week 4，week 8, week 20 and week 32.
Change of mean 24-hour stress IEF from baseline
week 4，week 8, week 20 and week 32.
- +7 more secondary outcomes
Other Outcomes (4)
Participants' expectations of improvement to urinary incontinence
Baseline assessment(week 0)
Participants' belief that acupuncture might help
Baseline assessment(week 0) and week 4.
Safety assessment
Throughout the trial
- +1 more other outcomes
Study Arms (3)
Electroacupuncture(EA) group
EXPERIMENTALParticipants in EA group will receive treatment at bilateral Bladder Meridian (BL) 33 \[Zhongliao\], BL35 \[Huiyang\] and Spleen Meridian (SP) 6 \[Sanyinjiao\]. The EA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.
Sham Electroacupuncture (SA) group
SHAM COMPARATORParticipants in SA group will receive treatment at bilateral sham BL33 \[Zhongliao\], sham BL35 \[Huiyang\] and sham SP6 \[Sanyinjiao\]. The SA treatment will last 30mins for each session, 3 sessions a week (ideally every other day) for a succession of 8 weeks.
Waiting List (WL) group
NO INTERVENTIONParticipants in WL group will be followed up for 20 weeks. Participants only receive healthcare education and advice on lifestyle modification, which will be received by all the participants in the three groups.
Interventions
BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.
Sham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.
Eligibility Criteria
You may qualify if:
- Diagnosis of MUI by the coexistence of SUI and urgency urinary incontinence (UUI) symptoms in accordance with EAU guideline;
- Female participants aged between 35 and 75;
- Stress index \> urge index in accordance with Medical, Epidemiologic, and Social aspects of Aging(MESA) questionnaire；
- Symptoms of MUI for at least three months, and stress IEF outnumber 50% total IEF documented in 3-day voiding diary;
- Less than 12 micturition episodes in average 24 hours documented in 3-day voiding diary;
- Positive cough stress test;
- Urine leakage \> 1 g in 1-hour pad test;
- Voluntary participation in the trial and signed written informed content.
You may not qualify if:
- Urgency-predominant MUI, pure SUI, pure UUI, overflow urinary incontinence (UI) and neurogenic bladder;
- Uncontrolled symptomatic urinary tack infection;
- Tumor in urinary system and pelvic organ;
- Pelvic organ prolapse ≥ degree Ⅱ；
- Residual urine volume ≥ 100ml；
- History of treatments targeted at UI, such as acupuncture, PFMT and medications in the previous one month;
- History of surgery targeted at UI or in pelvic floor, including hysterectomy;
- Uncontrolled diabetes or severe high blood pressure;
- 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;
- Severe heart, lung, brain, liver, kidney, mental illness, coagulation dysfunction or with obvious cognitive dysfunction
- Installed cardiac pacemaker;
- Inconvenient or unable to walk, run, go up and down stairs;
- Allergy to metal, severely fear of acupuncture needles or unbearable to EA;
- Pregnant at present, plan to conceive in future one year, at lactation period or within 12 months after childbirth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
The third affiliated hospital of Beijing university of Chinese Medicine
Beijing, Beijing Municipality, 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, China
Related Publications (1)
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.
PMID: 33414139DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhishun Liu
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of Acupuncture Department of Guang'anmen Hospital
Study Record Dates
First Submitted
March 5, 2020
First Posted
March 9, 2020
Study Start
October 9, 2020
Primary Completion
March 31, 2023
Study Completion
September 30, 2023
Last Updated
January 6, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Beginning immediately after publication and ending 6 months following article publication
- Access Criteria
- Proposals should be directed to zhishunjournal@163.com. To gain access, data requestors wil need to sign a data access agreement and offer payment.
Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.