GRADE approach assessment.

Purpose
To investigate the role of pelvic floor devices (e.g., biofeedback, electrical stimulation, magnetic stimulation, or their combination) as adjunctive treatments in pelvic floor muscle training (PFMT) in stress urinary incontinence (SUI) after radical prostatectomy.
Materials and methods
A systematic review with meta-analysis. We searched for randomised controlled trials (RCTs) and prospective non-randomised studies investigating the effectiveness of pelvic floor devices as an adjunctive treatment for SUI symptoms assessed with weight pad-test or standardised questionnaires. To assess the risk of bias (RoB) and overall certainty of evidence, the RoB 2.0 or the ROBINS-I, and the GRADE approach were used.
Results
Eleven RCTs met our eligibility criteria. One was at a ‘low’ RoB, one had ‘some concerns’, while nine were at a ‘high’ RoB. Two meta-analyses were conducted to analyse the pooled results of six RCTs included. Specifically, two RCTs reported at week 4 with a 1h pad test a mean difference of 0.64 (95% CI = [-13.09, 14.36]), and four RCTs reported at week 12 with a 24h pad test a mean difference of -47.75 (95% CI = [-104.18, 8.69]). The heterogeneity was high in both analyses (I2 = 80.0%; I2 = 80.6%). The overall level of certainty was very low.
Conclusions
In line with our results, we cannot conclude whether pelvic floor devices add any value as adjunctive treatment in the management of SUI after radical prostatectomy. Future studies require more comprehensive and standardised approaches to understand whether these devices are effective.