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

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.