Acupuncture for Stress-predominant Mixed Urinary Incontinence

Not Applicable

• Conditions: Mixed Urinary Incontinence
• Interventions: Procedure: Electroacupuncture; Procedure: Sham electroacupuncture

• Registration Number: NCT04299932
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-09
• Study Start: 2020-10-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06
• Primary Completion: 2023-03-31
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroacupuncture(EA) group	Electroacupuncture	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.
Sham Electroacupuncture (SA) group	Sham electroacupuncture	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.	week 8	The stress IEF will be documented in 3-day voiding diary.

Secondary Outcome Measures

Name	Time	Method
Change of mean 24-hour urgency episodes from baseline	week 4，week 8, week 20 and week 32	The urgency episodes will be documented in 3-day voiding diary.
Change of mean 24-hour micturition episodes from baseline	week 4，week 8, week 20 and week 32	The micturition episodes will be documented in 3-day voiding diary.
Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.	week 8	The urinary leakage amount will be measured by 1 hour pad test.
Change of urinary leakage amount from baseline	week 8	The urinary leakage amount will be measured by 1 hour pad test.
Change of mean 24-hour IEF from baseline.	week 4，week 8, week 20 and week 32.	The IEF will be documented in 3-day voiding diary.
Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline	week 4，week 8, week 20 and week 32	The IEF will be documented in 3-day voiding diary.
Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline	week 4，week 8, week 20 and week 32	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.
Change of mean 24-hour stress IEF from baseline	week 4，week 8, week 20 and week 32.	The stress IEF is documented in 3-day voiding diary.
Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.	week 4，week 20 and week 32	The stress IEF will be documented in 3-day voiding diary.
Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.	week 4，week 8, week 20 and week 32	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.
Change of mean 24-hour pad consumption from baseline	week 4，week 8, week 20 and week 32	The pad consumption will be documented in 3-day voiding diary.
Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).	week8, week 20	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".

Trial Locations

Locations (5)

Jiangxi Provincial Hospital of traditional Chinese Medicine; 🇨🇳 Nanchang, Jiangxi, China

Hengyang Hospital Affiliated to Hunan University of Chinese Medicine; 🇨🇳 Hengyang, Hunan, China

Yantai Hospital of Traditional Chinese Medicine; 🇨🇳 Yantai, Shandong, 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