盆底肌训练联合电刺激生物反馈对有症状盆腔器官脱垂女性的长期影响：随机对照试验

原文

ABSTRACT Objective To determine whether adding electrical stimulation (ES) biofeedback to supervised pelvic floor muscle training (PFMT) provides additional long-term benefit in prolapse anatomy among women with symptomatic pelvic organ prolapse (POP). Design Randomised controlled trial. Setting A tertiary hospital in Beijing, China. Population Primiparas (20–40 years) with symptomatic pelvic organ prolapse quantitation (POP-Q) stage II to III at 42–60 days postpartum following a full-term, vaginal singleton delivery. Methods We randomised 220 participants (1:1) to the intervention group (PFMT+ES+biofeedback) or control group (PFMT-only) for a 12-week intervention. The PFMT-only group received supervised PFMT (15 min/session, three times/week). The PFMT+ES+biofeedback group received two weekly sessions of ES (10 min) with biofeedback-mediated PFMT (15 min), and one session of supervised PFMT. Main Outcome Measures Primary outcome was POP-Q stage at 24 months. Secondary outcomes included Pelvic Floor Impact Questionnaire Short Form-7 (PFIQ-7) score, pelvic floor muscle (PFM) strength, PFM electromyography values, and economic analysis. Results At 24 months, the proportion of participants with improved POP-Q stage was not significantly different between PFMT+ES + biofeedback and PFMT-only groups. PFM strength demonstrated significant improvement in PFMT+ES + biofeedback group. No significant differences were observed in PFIQ-7 score or PFM electromyography values. Adding ES cost more, but had similar quality-adjusted life years. No adverse events were reported. Conclusions A single course of ES biofeedback plus supervised PFMT provides limited long-term benefit in postpartum prolapse. Trial Registration Chinese Clinical Trial Registry: ChiCTR1900021719; https://www.chictr.org.cn/showproj.html?proj=35452