Airbag-type Stretchable Electrode Array（ASEA） for Electrical Stimulation in Urinary Incontinence in Postmenopausal Women

The prevalence of the condition increases with age, and it is reported to affect 58%-84% of elderly women. Pelvic floor muscle training is the first-line management for urinary incontinence. Electrical stimulation is considered for improving contraction of pelvic floor muscles and aid motivation and adherence to therapy and commonly used in pelvic floor muscle training in clinic therapy. However, the stability and quality of the existing stretchable electronics are too poor especially when muscle movement is involved, making them inappropriate for high standard clinical treatment. Here, we propose a novel airbag-type stretchable electrode array (ASEA) device for training of the female pelvic floor muscle (PFM) for the treatment of UI. The aim of this study is to explore the efficacy and safety of in management of UI. In this study, the investigators hypothesis that ASEA device therapy is effective in controlling UI. A randomized, open, and controlled study will be implemented. Subjects were recruited in strict accordance the inclusion and exclusion criteria at the outpatient clinic. Patients with UI with Ingelman sundberg graduation (mild, moderate, moderate)≥mild UI will be included. Eligible subjects were randomized according to a computer-generated randomization schedule to to receive two-channel hard electrode or ASEA in a ratio of 1:1. Specific doctors will be designated for the disease diagnosis and treatment. The investigators were guided by Urinary incontinence and pelvic organ prolapse in women: management (NICE guideline,2019). The primary efficacy end points is the reduction of symptom scoring and improving of quality-of-life assessment. Bladder diaries and pad testing will be to performed to evaluate the frequency and quantify urine loss. The quality-of-life assessed with incontinence impact questionnaire short form (IIQ-7) and pelvic organ prolapsed- urinary incontinence sexual questionnaire-12 (PISQ-12), the higher the score, the greater the impact on the quality of life. The specification of the CONSORT case report system will be implemented. Sample size assessment according equivalence study. Follow-up and loss cases were strictly controlled. A two-sided test will performed with beta=0.80 and αlpha=0.05. The expected loss rate is calculated at 10%. 29 cases will be enrolled with 58 cases in each group. The study will be accepted regular monitoring and inspection.