Acupuncture for Stress-predominant Mixed Urinary Incontinence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Electroacupuncture for Stress-predominant Mixed Urinary Incontinence: a Three-armed Randomized Controlled Trial

Conditions
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Mixed Urinary Incontinence

Intervention / Treatment
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* Procedure: Electroacupuncture
* Procedure: Sham electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture(EA) group<br>Participants 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. | Procedure: Electroacupuncture<br>* 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.<br>* Other names: EA;|
| Sham Comparator: Sham Electroacupuncture (SA) group<br>Participants 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. | Procedure: Sham electroacupuncture<br>* 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.<br>* Other names: SA;|
| No Intervention: Waiting List (WL) group<br>Participants 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change of urinary leakage amount from baseline | The urinary leakage amount will be measured by 1 hour pad test. | week 8 | 
| 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 | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 ofmuch better or very much better. | week8, week 20 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, stress-predominant mixed urinary incontinence