The effectiveness of invasive and non-invasive biofeedback-assisted pelvic floor muscle training with or without electrical stimulation for the treatment of stress urinary incontinence in women: a systematic review with meta-analysis and meta-regression of randomized controlled trials.

BACKGROUND

Previous reviews evaluating biofeedback (BF)-assisted pelvic floor muscle (PFM) training (PFMT) with or without electrical stimulation (ES) for women with stress urinary incontinence (SUI) have reported conflicting results, and no consensus has been reached on the optimal parameters for this intervention.

OBJECTIVES

To (1) evaluate the effectiveness of non-invasive and invasive BF-assisted PFMT with or without ES for SUI in women and (2) investigate whether study design characteristics and intervention parameters affect treatment effects.

DESIGN

Systematic review with meta-analysis and meta-regression.

DATA SOURCES AND

METHODS

Seven English and two Chinese databases were searched from inception to May 2025. Outcomes were synthesized as standardized mean differences (SMDs) or odds ratios (ORs) with 95% confidence intervals. Meta-regression was employed to investigate the impact of study design characteristics and intervention parameters on outcomes.

RESULTS

This review included 21 studies involving 2373 participants. Meta-analyses revealed significant effects of invasive BF-assisted PFMT on PFM strength (SMD 0.71 (0.29, 1.14), p = 0.001), urinary incontinence (UI) symptom severity (SMD -0.33 (-0.63, -0.03), p = 0.032), quality of life (QoL; SMD -1.10 (-1.78, -0.41), p = 0.002), and improvement/cure rate (OR 2.02 (1.25, 3.26), p = 0.004). Meta-analyses also revealed significant effects of both invasive (SMD -1.23 (-1.93, -0.52), p = 0.001) and non-invasive (SMD -1.23 (-1.77, -0.68), p < 0.001) BF-assisted PFMT on urine loss severity. Meta-regression analysis revealed higher improvement/cure rates when BF-assisted PFMT involved mildly challenging exercises, tailoring to patients' abilities, therapist supervision, sessions of <10 min, durations of >1 h/week for ⩾8 weeks, and ⩾80%-95% adherence.

CONCLUSION

Invasive BF-assisted PFMT can improve PFM strength, reduce urine loss and UI symptom severity, enhance QoL, and increase the improvement/cure rate. Non-invasive BF-assisted PFMT can reduce urine loss severity. However, these results must be interpreted cautiously due to methodological flaws, risks of bias, and substantial heterogeneity across the included studies. Further high-quality studies are warranted to confirm the effectiveness of invasive or non-invasive BF-assisted PFMT with or without ES for treating SUI in women. The recommended parameters may optimize treatment effects.

TRIAL REGISTRATION: PROSPERO (CRD42023473798).