Long‐Term Effects of Pelvic Floor Muscle Training Combined With Electrical Stimulation Biofeedback Among Women With Symptomatic Pelvic Organ Prolapse: A Randomised Controlled Trial
Min Li, Yuhan Lyu, Pingping Li, Yaxin Liang, Tianzi Gai, Qiubo Lyu, Shuai Huang, Lin Liang, Yue Yu, Xinyue ZhangABSTRACT
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;