# Clinical efficacy of electroacupuncture on pelvic floor function in women with stress urinary incontinence: a randomized sham-controlled trial protocol

## TL;DR

This study will test if electroacupuncture improves pelvic floor function in women with stress urinary incontinence, using objective measurements like muscle activity and ultrasound.

## Contribution

This is the first randomized sham-controlled trial to systematically evaluate electroacupuncture's effects on pelvic floor function in stress urinary incontinence patients.

## Key findings

- Electroacupuncture may improve pelvic floor muscle activity in SUI patients.
- The study will provide objective evidence on how EA affects pelvic floor function.
- Results could clarify the mechanism behind EA's therapeutic effects on SUI.

## Abstract

Stress urinary incontinence (SUI) is a prevalent condition among adult women, significantly impairing quality of life. Patients with SUI often exhibit abnormal pelvic floor muscle function, which can be comprehensively assessed using surface electromyography (sEMG) and transperineal ultrasound (TPUS). Electroacupuncture (EA) is an effective treatment for SUI, and multiple studies have confirmed its clinical efficacy; however, objective evidence regarding its impact on pelvic floor muscle function remains limited. This study aims to evaluate the clinical efficacy of EA applied to lower abdominal acupoints for SUI and to explore its impact on pelvic floor function, thereby providing mechanistic insights into EA's therapeutic effect on mild to moderate SUI.

This is a randomized, single-blind trial with a 1:1 allocation ratio. A total of 64 participants will be enrolled. Following screening, eligible female patients with SUI will be randomly allocated to either the EA group (n = 32) or the sham EA group (n = 32), receiving EA or sham EA treatment, respectively. The intervention period will last 6 weeks. The primary outcome is the change in urine leakage, measured by the 1-hour pad test, from baseline to week 6. Secondary outcomes include: the incontinence episode frequency (IEF); the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score; SUI severity; weekly urine pad usage; participants' self-assessment of therapeutic effect; pelvic floor muscle sEMG parameters; TPUS measurements; discomfort during treatment assessed by a Visual Analog Scale (VAS); participants' acceptability; and intervention-related adverse events.

By comprehensively evaluating symptom improvement, temporal effects, and pelvic floor functional changes following EA treatment for SUI, this study aims to systematically elucidate the therapeutic effects of EA and its mechanism of action on the pelvic floor. The findings are expected to provide robust evidence to support the clinical application of EA for SUI.

https://itmctr.ccebtcm.org.cn/mgt/project/view/-6004709097458762939, identifier ITMCTR2024000151.