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Acupuncture for Stress-predominant Mixed Urinary Incontinence

Primary Purpose

Mixed Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham electroacupuncture
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Urinary Incontinence focused on measuring acupuncture, stress-predominant mixed urinary incontinence

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical SciencesRecruiting
  • The third affiliated hospital of Beijing university of Chinese MedicineRecruiting
  • Hengyang Hospital Affiliated to Hunan University of Chinese MedicineRecruiting
  • Jiangxi Provincial Hospital of traditional Chinese MedicineRecruiting
  • Yantai Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Electroacupuncture(EA) group

Sham Electroacupuncture (SA) group

Waiting List (WL) group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change of urinary leakage amount from baseline
The urinary leakage amount will be measured by 1 hour pad test.
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.
Change of mean 24-hour IEF from baseline.
The IEF will be documented in 3-day voiding diary.
Change of mean 24-hour stress IEF from baseline
The stress IEF is documented in 3-day voiding diary.
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.
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.
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.
Change of mean 24-hour pad consumption from baseline
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).
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".
Change of mean 24-hour urgency episodes from baseline
The urgency episodes will be documented in 3-day voiding diary.
Change of mean 24-hour micturition episodes from baseline
The micturition episodes will be documented in 3-day voiding diary.

Full Information

First Posted
March 5, 2020
Last Updated
January 5, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT04299932
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Urinary Incontinence
Keywords
acupuncture, stress-predominant mixed urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture(EA) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Electroacupuncture (SA) group
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Waiting List (WL) group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Other Intervention Name(s)
EA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham electroacupuncture
Other Intervention Name(s)
SA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants with at least 50% reduction of mean 24-hour stress incontinence episode frequency (IEF) from baseline.
Description
The stress IEF will be documented in 3-day voiding diary.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Proportion of participants with at least 50% reduction of urinary leakage amount from baseline.
Description
The urinary leakage amount will be measured by 1 hour pad test.
Time Frame
week 8
Title
Change of urinary leakage amount from baseline
Description
The urinary leakage amount will be measured by 1 hour pad test.
Time Frame
week 8
Title
Proportion of participants with at least 50% reduction of mean 24-hour stress IEF from baseline.
Description
The stress IEF will be documented in 3-day voiding diary.
Time Frame
week 4，week 20 and week 32
Title
Change of mean 24-hour IEF from baseline.
Description
The IEF will be documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32.
Title
Change of mean 24-hour stress IEF from baseline
Description
The stress IEF is documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32.
Title
Proportion of participants with at least 50% reduction of mean 24-hour IEF from baseline
Description
The IEF will be documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32
Title
Change of total and sub-score of International Consultation on Incontinence Questionnaire-short form (ICIQ-SF) from baseline.
Description
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.
Time Frame
week 4，week 8, week 20 and week 32
Title
Change of total and sub-score of Overactive Bladder Questionnaire short form (OAB-q SF) from baseline
Description
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.
Time Frame
week 4，week 8, week 20 and week 32
Title
Change of mean 24-hour pad consumption from baseline
Description
The pad consumption will be documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32
Title
Proportion of participants with adequate improvement assessed by Patient global impression improvement (PGI-I).
Description
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".
Time Frame
week8, week 20
Title
Change of mean 24-hour urgency episodes from baseline
Description
The urgency episodes will be documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32
Title
Change of mean 24-hour micturition episodes from baseline
Description
The micturition episodes will be documented in 3-day voiding diary.
Time Frame
week 4，week 8, week 20 and week 32
Other Pre-specified Outcome Measures:
Title
Participants' expectations of improvement to urinary incontinence
Description
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；
Time Frame
Baseline assessment(week 0)
Title
Participants' belief that acupuncture might help
Description
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；
Time Frame
Baseline assessment(week 0) and week 4.
Title
Safety assessment
Description
Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not.
Time Frame
Throughout the trial
Title
Blinding assessment
Description
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.
Time Frame
Within 5 minutes after either treatment at week 8

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishun Liu
Phone
+861088002331
Email
zhishunjournal@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
yuanjie sun
Phone
18810337542
Email
puzhisun@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu
Email
zhishunjournal@163.com
Facility Name
The third affiliated hospital of Beijing university of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Bai
Email
baipeng1978@163.com
Facility Name
Hengyang Hospital Affiliated to Hunan University of Chinese Medicine
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zenghui Yue
Email
624755064@qq.com
Facility Name
Jiangxi Provincial Hospital of traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Fu
Email
fuyong1125@163.com
Facility Name
Yantai Hospital of Traditional Chinese Medicine
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiwei Zang
Email
860922902@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.
IPD Sharing Time Frame
Beginning immediately after publication and ending 6 months following article publication
IPD Sharing 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.
Citations:
PubMed Identifier
33414139
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.
Results Reference
derived

Learn more about this trial

Acupuncture for Stress-predominant Mixed Urinary Incontinence

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