Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised parallel group trial

Abstract Background Women with stress urinary incontinence (SUI) often present with very weak pelvic floor muscles (PFM); this deficit reduces the effectiveness of pelvic floor muscle training (PFMT). Aim To determine whether adding sEMG-triggered intravaginal electrical stimulation to supervised PFMT improves PFM strength and continence outcomes compared with PFMT plus sham stimulation in women with SUI and very weak PFMs. Methods In this multicentre, randomized, double-blind, parallel-group trial, 42 women with SUI were allocated to: (1) PFMT + sEMG-triggered electrical stimulation, or (2) PFMT + placebo stimulation. Both groups received supervised PFMT three times/week for 10 weeks plus a daily home program. Change in PFM strength at 10 weeks and 6/12 months follow-up, was the primary outcome. Secondary outcomes included weekly leakage episodes, pad-test leakage volume, pad use, ICIQ-SF score, and PGI-I. Results Thirty-six participants completed the 12-month follow-up (19 experimental, 17 control). A significant Group × Time interaction was observed for PFM strength (p = 0.028). Between-group differences emerged at 10 weeks (+0.48 Oxford points; p = 0.033) and were sustained at 6 and 12 months (+0.59 at 12 months; p = 0.009). At 12 months, experimental group showed larger reductions in weekly leakage (−1.51 episodes/week; p = 0.001), pad use (−2.6 pads/day; p < 0.001), and ICIQ-SF score (−5.20 points; p < 0.001), all exceeding clinical relevance thresholds. Clinically meaningful improvement on PGI-I was reported by 65% of experimental participants versus 18% of controls. Sensitivity analyses confirmed the robustness of findings. Conclusions In women with SUI and very weak PFMs, adding sEMG-triggered intravaginal stimulation to supervised PFMT produced earlier, greater, longer-lasting improvements in PFM strength, continence, and patient-reported outcomes.