Electroacupuncture versus sham electroacupuncture in the treatment of female stress urinary incontinence: a randomized controlled trial protocol

Abstract

Abstract Background: Stress urinary incontinence (SUI) is defined as involuntary leakage of urine due to increased abdominal pressure. Previous studies have confirmed that electroacupuncture is an effective alternative approach for treating SUI; yet, objective evidence of its mechanism of action is still lacking. Patients with SUI often harbor structural changes in the pelvic floor, which can be easily detected on transperineal ultrasound (TPUS). The aim of this study was to assess the effect of electroacupuncture involving the lower abdomen, compared with sham electroacupuncture in women with SUI, and observe changes in pelvic floor structure by TPUS. Methods: Seventy-four female patients with SUI will be included in this study and randomly assigned to the test and control groups at a 1:1 ratio. Both groups will be treated with pelvic floor muscle training. In addition,patients in the test group will be subjected to electroacpuncture (EA) (at Zhongji (RN3), Guanyuan (RN4), and Dahe (KI12) acupoints), while the control group will be subjected to sham electroacupuncture (SEA) at same acupoints. Bothgroups will be treated three times a week for 6 weeks. The primary outcomes include change from baseline to week 6 in the bladder neck descent (BND) and the urine leakage measured by the 1-h pad test. Secondary outcomes include an objective degree of incontinence, subjective severity of incontinence, ICIQ-SF score, mean 24-h incontinence episodes, and subjective evaluation of incontinence leakage degree. TPUS will be used to observe the changes of parameters on the pelvic floor structure, such as urethral rotation angle (URA), retrovesical angle (RVA), the bladder neck position (BN-S), urethral funneling, and bladder bulging. The safety evaluation, and participant acceptance evaluation of the treatment will also be performed. Discussion: The study may help objectively document the efficacy of electroacupuncture in SUI and clarify its mechanism of action. Trial registration: Registration in the Chinese Clinical Trial Registry (ChiCTR2100050792)(http://www.chictr.org.cn/showproj.aspx?proj=132759),was effective September 4, 2021.