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).
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.
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.
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.
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.
European journal of obstetrics, gynecology, and reproductive biology. 2026 May 24 [Epub ahead of print]
Gianfranco Lamberti, Gianluca Ciardi, Donatella Giraudo, Anna Di Meo
Department of Medicine and Surgery, University of Parma 43121 Parma, Italy; Department of Physical Medicine and Rehabilitation, AUSL Piacenza 29121 Piacenza, Italy., University of Parma-Department of Medicine and Surgery-Degree Course in Physiotherapy-Piacenza Training Centre, 29017 Fiorenzuola d'Arda, Italy; Department of Social and Health Professions, AUSL Piacenza 29121 Piacenza, Italy. Electronic address: ., Department of Urology, San Raffaele Turro Hospital, 20132 Milano, Italy., University of Genova-Master Degree in Health Professions' Rehabilitation Science Student, Via Balbi 5, 16126, Genova, Italy.