Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

Mixed Urinary Incontinence Clinical Trial

Official title:

Electroacupuncture for Women With Mixed Urinary Incontinence: a Sham-controlled Randomised Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05505526
• Other study ID #: 2022-174-KY
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Hangyu Shi
• Phone: +8618811735839
• Email: shihangyutcm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Mixed Urinary Incontinence
• Urinary Incontinence

Intervention

Other:
• Electroacupuncture
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 electroacupuncture
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.

Locations

Country	Name	City	State
China	Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shi Hangyu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.	72-hour incontinence episodes dairy	week 8
Secondary	the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes	72-hour incontinence episodes dairy	week 4, 20, 32
Secondary	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	week 4, 8, 20, 32
Secondary	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	week 4, 8, 20, 32
Secondary	the change from baseline in the amount of urine leakage measured by the 1-hour pad test	1-hour pad test	baseline, week 8
Secondary	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.	week 4, 8, 20, 32
Secondary	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.	week 4, 8, 20, 32
Secondary	incidence rate of any adverse events	adverse event will be documented as soon as it is reported during treatments and follow-ups	up to 32 weeks
Secondary	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.	baseline
Secondary	blinding assessment	patients will be asked whether they received electroacupuncture or sham electroacupuncture	week 8