Key Finding
This trial protocol will evaluate electroacupuncture's effects on stress urinary incontinence using both clinical outcomes and objective pelvic floor muscle measurements via electromyography and ultrasound to elucidate therapeutic mechanisms.
Researchers are conducting a clinical trial to test whether electroacupuncture can help women with stress urinary incontinence (SUI), a common condition where urine leaks during physical activities like coughing, sneezing, or exercise. This condition affects many women and can significantly impact daily life and confidence.
The study will enroll 64 women with mild to moderate SUI, randomly assigning half to receive real electroacupuncture treatments and half to receive sham (placebo) treatments on their lower abdomen. Neither the participants nor evaluators will know which treatment they're receiving. The treatments will occur over 6 weeks, and researchers will measure several outcomes including the amount of urine leakage using a 1-hour pad test, frequency of leaking episodes, and quality of life questionnaires.
What makes this study particularly interesting is that researchers will use advanced imaging techniques and muscle measurements to understand exactly how electroacupuncture affects the pelvic floor muscles. They'll use surface electromyography to measure muscle electrical activity and ultrasound to visualize structural changes in the pelvic floor.
This is a protocol publication, meaning the study is planned but results are not yet available. When completed, it will provide important evidence about whether electroacupuncture can objectively improve pelvic floor muscle function, not just reduce symptoms. This could help explain the mechanisms behind acupuncture's effects on urinary incontinence and provide stronger scientific support for its use.
If you're interested in acupuncture for stress urinary incontinence, seek care from a licensed acupuncturist with experience treating pelvic floor conditions.
This randomized, single-blind, sham-controlled trial protocol aims to evaluate electroacupuncture (EA) efficacy for stress urinary incontinence (SUI) while elucidating mechanisms through objective pelvic floor assessment. The study will randomize 64 women with mild-to-moderate SUI in a 1:1 ratio to EA or sham EA targeting lower abdominal acupoints over 6 weeks.
The primary outcome is change in urine leakage measured by 1-hour pad test from baseline to week 6. Secondary outcomes include incontinence episode frequency, ICIQ-SF scores, SUI severity grade, pad usage, patient global assessment, and notably, objective pelvic floor measurements via surface electromyography (sEMG) and transperineal ultrasound (TPUS). Safety parameters include VAS discomfort scores and adverse events.
This protocol addresses a critical evidence gap by incorporating objective neuromuscular and structural assessments of pelvic floor function alongside standard clinical outcomes. The comprehensive evaluation design may provide mechanistic insights into EA's therapeutic action on pelvic floor dysfunction underlying SUI, potentially strengthening the evidence base for clinical application in this prevalent condition affecting women's quality of life.
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