Immediate effect of acupuncture on pelvic floor muscles function for stress urinary incontinence in women: study protocol for a randomized and sham-controlled trial.

Introduction: Stress urinary incontinence (SUI) is a common condition in middle-aged and elderly women, significantly impacting their quality of life. Weakening of pelvic floor muscle function is considered one of the main factors contributing to SUI. Despite the established clinical use of acupuncture therapy in treating stress urinary incontinence (SUI), the exact mechanisms underlying its effectiveness require further exploration. This study aimed to assess changes in pelvic floor muscle function during acupuncture using surface electromyography (sEMG). This trial will focus on investigating whether the mechanism by which acupuncture alleviates symptoms in SUI patients is related to the improvement of pelvic floor muscle function. Methods: This study will be a randomized, single-blind, and sham-controlled trial. The study will recruit 76 female patients diagnosed with SUI. They will be randomly allocated to two groups: acupuncture and sham acupuncture, in a 1:1 ratio. Each group of subjects will receive 10 min of acupuncture treatment at RN3 (Zhongji). Outcomes will be assessed at three time points: baseline, during intervention, and 10 min post-intervention, using pelvic floor muscle sEMG. The primary outcome will be the difference in mean amplitude (μV) of the sEMG recordings during the 10-second tonic contraction phase between the acupuncture and sham acupuncture groups. Secondary outcomes will include assessments of amplitude, variation coefficient, and relaxation time across the other phases of the sEMG evaluation. The trial will record adverse events related to the intervention. Discussion: This study aims to observe the real-time impact of acupuncture on pelvic floor muscle function using sEMG and to explore how acupuncture exerts its effects. Clinical trial registration: https://www.chictr.org.cn/, Identifier ChiCTR2200059686.