Electroacupuncture vs Sham Electrocupuncture for Mixed Urinary Incontinence

NCT05505526 | Unknown DMC

• 1 other identifier: 2022-174-KY
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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).

Conditions

Mixed Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  week 4, 20, 32

• the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes

  week 4, 8, 20, 32

• the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes

  week 4, 8, 20, 32

• the change from baseline in the amount of urine leakage measured by the 1-hour pad test

  baseline, week 8

• the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores

  week 4, 8, 20, 32

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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.

Other: Electroacupuncture

Sham electroacupuncture

SHAM COMPARATOR

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.

Other: Sham electroacupuncture

Interventions

Electroacupuncture OTHER

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.

Also known as: EA

Electroacupuncture

Sham electroacupuncture OTHER

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.

Also known as: SA

Sham electroacupuncture

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shi Hangyu: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Hangyu Shi

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hangyu Shi

CONTACT

+8618811735839; shihangyutcm@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: August 18, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)