Effect of Electroacupuncture on Mixed Urinary Incontinence Among Women

NCT04531683 | Unknown

• 1 other identifier: ZZ13-024-9
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the efficacy and safety of electroacupuncture on mixed urinary incontinence among women.

Conditions

Urinary Incontinence, Mixed

Keywords

acupuncture; randomised controlled trial; sham acupuncture

Outcome Measures

Primary Outcomes (1)

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

  data will be collected and evaluated by 72-hour incontinence episodes dairy

  at the 8th week after the last treatment

Secondary Outcomes (10)

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

  at baseline, 4th, 20th and 32nd week

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

  at baseline, 4th, 8th 20th and 32nd week

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

  at baseline, 4th, 8th, 20th and 32nd week

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

  at baseline, and the 8th week

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

  at baseline, 4th, 8th, 20th and 32nd week

Study Arms (3)

electroacupuncture

EXPERIMENTAL

patients will receive electroacupuncture at 3 acupoints (Bladder meridian of foot-taiyang 33 and 35（BL33 and BL35), and Spleen meridian of foot-taiyin 33(SP6)) 3 times/week for 8 weeks(24 times in total), followed with 24-weeks follow up. Disposable acupuncture needles with size of 0.30 × 75 mm will be used at BL 33 and BL 35, and needles with size of 0.30 × 40 mm at SP 6. Standardised electroacupuncture apparatuses will be used, and the stimulation will last for 30 minutes with a continuous wave of 20 Hz, and a current intensity of 2 to 6.5 mA at BL33 and BL 35, and 1 to 3.5 mA at SP6. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.

Other: electroacupuncture; Behavioral: life style counselling

sham electroacupuncture

SHAM COMPARATOR

patient will receive sham electroacupuncture with the same frequency and amount as applied in the electroacupuncture group, as well as the follow-up period. Disposable acupuncture needles with size of 0.30 × 40 mm will be applied and penetrate the skin of patients for 2 to 3mm at sham acupoints to the 3 acupoints mentioned above. The stimulation will only last for 30-second with a very weak currency intensity and a continuous wave of 20 Hz. Life style counselling will be provided to all patients and contents are as same as the life style counselling group.

Other: sham electroacupuncture; Behavioral: life style counselling

life style counselling group

OTHER

patients randomised to this group will receive a one-time life style counselling at the enrolment to improve their daily behaviour to expedite the recovery of their mixed urinary incontinence. Then the patients will be followed up for 20 weeks.

Behavioral: life style counselling

Interventions

electroacupuncture OTHER

same as described in experimental arm.

electroacupuncture

sham electroacupuncture OTHER

same as described in sham comparator.

sham electroacupuncture

life style counselling BEHAVIORAL

life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.

electroacupuncture; life style counselling group; 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:

• Patients are female and meet the diagnosis criteria of mixed urinary incontinence;
• Patients are between age of 35 to 75 years old;
• Positive in cough stress test;
• Experience persistent urinary incontinence for at least 3 months, and at least one episode for each of stress and urgent urinary incontinence in 72 hours in baseline screening; and
• Patients have signed informed consent form and are willing to participate the study voluntarily.
• Patients will be included if all above 5 items are met.

You may not qualify if:

• Patients have simple stress urinary incontinence, simple urgent urinary incontinence, overflowing urinary incontinence and neurogenic bladder, etc.;
• Patients have uncontrolled urinary tract infection with urinary pain and urge;
• Patients have 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;
• Patients have history of surgeries for urinary incontinence and/or pelvic floor organs, including hysterectomy;
• Patients have pelvic organ prolapse ≥ II degree;
• Patients have residual urine ≥ 100ml;
• Patients have uncontrolled diabetes mellitus and severe hypertension;
• Patients have diseases affecting lower urinary tract function, e.g. multiple sclerosis, Alzheimer's disease, Parkinson's disease, spinal cord injury, cauda equina injury and multiple system atrophy, etc.;
• Patients have severe heart, lung, brain, liver, kidney and hematopoietic system diseases, mental disorders and cognitive dysfunction;
• Patients are constrained or unable to complete movements like walking, going stairs up and down and running, etc.;
• Patients have poor compliance;
• Patients are at pregnancy, breastfeeding or postpartum period for less than 12 months;
• Patients have cardiac pacemaker, metal allergy or strong fear of needle;
• Patients are participants of other on-going studies; or

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Shaanxi Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator
• Hubei Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• Second Affiliated Hospital of Heilongjiang University of Chinese Medicine: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Zhishun Liu, PhD

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huan Chen, MPH, MD

CONTACT

+86 10 88002331; chen.huan@live.com

Zhishun Liu, PhD,MD

CONTACT

+86 10 88002331; liuzhishun@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigator and outcome assessor will be masked. The care provider will be different from investigator and outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dean of Acupuncture Department

Model Details: Patients who sign the informed consent form and are eligible for the study entry at week 0 will be randomised to one of the three groups: electro-acupuncture group, sham electroacupuncture group and life style consultation group. The three group will be assessed in a paralleled manner, and patients in the first two groups will be treated 3 times per week for 8 weeks and followed up for 24 weeks, while patients in the third group will be provided with life style improvement information once and followed-up for 20 weeks.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 28, 2020
• Study Start: October 30, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share