Long-Term Effects of Pelvic Floor Muscle Training Combined With Electrical Stimulation Biofeedback Among Women With Symptomatic Pelvic Organ Prolapse: A Randomised Controlled Trial.

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.