Does neuromuscular electrical stimulation improve lower urinary tract dysfunction in people with multiple sclerosis (MS), when given in addition to pelvic floor exercises and electromyographic biofeedback? Randomised, controlled trial with concealed allocation and blinded assessment of some outcomes. Twelve health-care facilities in Northern Ireland. Adults with MS with no hospital admissions in the preceding 3 months. They were required to have lower urinary tract dysfunction (involuntary leakage, > 8 voids per day, nocturia, or voiding dysfunction) but not to score more than 7.5 on the Expanded Disability Status Scale (EDSS) from 0 (normal) to 10 (death due to MS). Symptomatic prolapse, prostatic hyperplasia, infection and contraindications to electrical stimulation were exclusion criteria. Randomisation of 74 participants allotted 37 to each of two groups. Both groups were taught skills and strategies to prevent incontinence and trained in pelvic floor muscle exercises. Both groups were taught to perform the exercises with electrical stimulation via a hand-held unit with a vaginal or anal probe. The treatment group received active stimulation while the control group received sham stimulation. Both groups performed the exercises daily for 9 weeks. The exercises were reviewed with electromyographic biofeedback at a weekly clinic visit. The primary outcome was the number of leakage episodes per day as monitored by diary. Secondary outcome measures included gain in pad weight after use, voiding measures, symptom questionnaires, and assessment of pelvic floor muscle function using the Oxford classification and EMG. All outcomes were measured at 9, 16, and 24 weeks. In each group, 36 participants completed the study. At 9 weeks, the treatment group had significantly less incontinence, with 0.8 fewer episodes per day (95% CI 0.1 to 1.4) and 89 g lighter pads (95% CI 8 to 171) than the control group. The treatment group also had significantly larger voids, by 47 ml (95% CI 1 to 93), and significantly smaller post-void residual volumes. Symptoms were also rated as significantly less bothersome. At 24 weeks, however, pad weight was the only objective outcome that remained statistically significant. Nevertheless, patients in the treatment group still rated their symptoms as significantly less bothersome on two questionnaires. For people with MS, the addition of electrical stimulation to a program of pelvic floor muscle training and EMG biofeedback induces several improvements in lower urinary tract dysfunction. Although some improvements were temporary, symptoms remained less bothersome for 24 weeks.
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