Clinical trial NCT05505526: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Urinary Incontinence
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 222
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes.
timeFrame: week 8
Secondary outcomes:
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour incontinence episodes
timeFrame: week 4, 20, 32
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour urgent incontinence episodes
timeFrame: week 4, 8, 20, 32
measure: the proportion of participants with at least 50 percent decrease from baseline in the mean 24-hour stress incontinence episodes
timeFrame: week 4, 8, 20, 32
measure: the change from baseline in the amount of urine leakage measured by the 1-hour pad test
timeFrame: baseline, week 8
measure: the change from baseline in the validated Chinese version of International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) scores
timeFrame: week 4, 8, 20, 32
measure: the change from baseline in the validated Chinese version of the Overactive Bladder Questionnaire-Short Form scores
timeFrame: week 4, 8, 20, 32
measure: incidence rate of any adverse events
timeFrame: up to 32 weeks
measure: patients' expectation to treatment
timeFrame: baseline
measure: blinding assessment
timeFrame: week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Hangyu Shi
role: PRINCIPAL_INVESTIGATOR
References: