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Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

Primary Purpose

Mixed Urinary Incontinence

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Electroacupuncture
Sham electroacupuncture
Sponsored by
Shi Hangyu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mixed Urinary Incontinence

Eligibility Criteria

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

Inclusion Criteria:

  • Female, 35 to 75 years old
  • Diagnosed as mixed urinary incontinence
  • Positive in cough stress test
  • Experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening
  • Sign the informed consent form

Exclusion Criteria:

  • Diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc.
  • Uncontrolled urinary tract infection with urinary pain and urge
  • Urogenital system tumours and/or pelvic organ tumours
  • Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month
  • History of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; Patients have pelvic organ prolapse ≥ II degree
  • Residual urine ≥ 100ml
  • Uncontrolled diabetes mellitus and severe hypertension
  • Diseases affecting lower urinary tract function
  • Severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction
  • Constrained or unable to complete movements like walking, going stairs up and down and running, etc.
  • At pregnancy, breastfeeding or postpartum period for less than 12 months
  • Cardiac pacemaker, metal allergy or strong fear of needle
  • Patients have received acupuncture in the past 3 months

Sites / Locations

  • Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture

Sham electroacupuncture

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.

Outcomes

Primary Outcome Measures

the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
72-hour incontinence episodes dairy

Secondary Outcome Measures

the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
72-hour incontinence episodes dairy
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
72-hour incontinence episodes dairy
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
72-hour incontinence episodes dairy
the change from baseline in the amount of urine leakage measured by the 1-hour pad test
1-hour pad test
the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
data will be collected via International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF). The total score(0-21scores) is an accumulated scores from question 1 to 3. The higher the total score is, the severer the incontinence is.
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
data will be collected via the Overactive Bladder Questionnaire-Short Form (0-15 scores). The higher the total score is, the severer the condition is.
incidence rate of any adverse events
adverse event will be documented as soon as it is reported during treatments and follow-ups
patients' expectation to treatment
patients will be asked about their expected effect of the treatment via question: In your expectation, how is your incontinence like in a two month time. Five choices will be provided 1) much better; 2) slightly better; 3) I don't know; 4) no change; 5) worse.
blinding assessment
patients will be asked whether they received electroacupuncture or sham electroacupuncture

Full Information

First Posted
August 12, 2022
Last Updated
August 15, 2022
Sponsor
Shi Hangyu
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1. Study Identification

Unique Protocol Identification Number
NCT05505526
Brief Title
Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence
Official Title
Electroacupuncture for Women With Mixed Urinary Incontinence: a Sham-controlled Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 18, 2022 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Hangyu

4. Oversight

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

5. Study Description

Brief Summary
The investigators plan to conduct this randomized sham-controlled clinical trial to evaluate the efficacy and safety of electroacupuncture (EA), compared with sham electroacupuncture (SA) on women with 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. Electroacupuncture has been proved not inferior to pelvic floor muscle training plus solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Urinary Incontinence

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Electroacupuncture
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
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.
Intervention Type
Other
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
Other
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
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
Description
72-hour incontinence episodes dairy
Time Frame
week 8
Secondary Outcome Measure Information:
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
Description
72-hour incontinence episodes dairy
Time Frame
week 4, 20, 32
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
Description
72-hour incontinence episodes dairy
Time Frame
week 4, 8, 20, 32
Title
the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
Description
72-hour incontinence episodes dairy
Time Frame
week 4, 8, 20, 32
Title
the change from baseline in the amount of urine leakage measured by the 1-hour pad test
Description
1-hour pad test
Time Frame
baseline, week 8
Title
the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
Description
data will be collected via International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF). The total score(0-21scores) is an accumulated scores from question 1 to 3. The higher the total score is, the severer the incontinence is.
Time Frame
week 4, 8, 20, 32
Title
the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
Description
data will be collected via the Overactive Bladder Questionnaire-Short Form (0-15 scores). The higher the total score is, the severer the condition is.
Time Frame
week 4, 8, 20, 32
Title
incidence rate of any adverse events
Description
adverse event will be documented as soon as it is reported during treatments and follow-ups
Time Frame
up to 32 weeks
Title
patients' expectation to treatment
Description
patients will be asked about their expected effect of the treatment via question: In your expectation, how is your incontinence like in a two month time. Five choices will be provided 1) much better; 2) slightly better; 3) I don't know; 4) no change; 5) worse.
Time Frame
baseline
Title
blinding assessment
Description
patients will be asked whether they received electroacupuncture or sham electroacupuncture
Time Frame
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: Female, 35 to 75 years old Diagnosed as mixed urinary incontinence Positive in cough stress test Experiencing persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in baseline screening Sign the informed consent form Exclusion Criteria: Diagnosed as simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence or neurogenic bladder, etc. Uncontrolled urinary tract infection with urinary pain and urge Urogenital system tumours and/or pelvic organ tumours Patients have taken drugs for urinary incontinence treatment or drugs possibly affect the function of lower urinary tract, or received non-drug treatment for urinary incontinence (i.e. electrical stimulation, bladder training, pelvic floor muscle training, and etc.) in the past one month History of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy; Patients have pelvic organ prolapse ≥ II degree Residual urine ≥ 100ml Uncontrolled diabetes mellitus and severe hypertension Diseases affecting lower urinary tract function Severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction Constrained or unable to complete movements like walking, going stairs up and down and running, etc. At pregnancy, breastfeeding or postpartum period for less than 12 months Cardiac pacemaker, metal allergy or strong fear of needle Patients have received acupuncture in the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hangyu Shi
Phone
+8618811735839
Email
shihangyutcm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hangyu Shi
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hangyu Shi

12. IPD Sharing Statement

Plan to Share IPD
No

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Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

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