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Effects of biofeedback-guided pelvic floor muscle training with and without extracorporeal magnetic innervation therapy on stress incontinence: a randomized controlled trial
Gumussoy S, Kavlak O, Yeniel AO
Journal of Wound, Ostomy, and Continence Nursing 2021 Mar-Apr;48(2):153-161
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: We evaluated the effects of biofeedback-guided pelvic floor muscle training (EMG-BF), with and without extracorporeal magnetic innervation (EMG-BF+ExMI) therapy on lower urinary tract symptoms based on frequency of stress urinary incontinence (SUI) and grams of urine loss, health-related quality of life, and sexual function in women with SUI. DESIGN: This was a randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 51 adult women with SUI. Their mean age was 50.92 years (SD 8.88). Twenty-six were randomly allocated to EMG-BF alone and 25 were allocated to undergo EMG-BF+ ExMI. METHODS: This study's main outcome was lower urinary tract symptoms measured via the 1-hour pad test (grams of urine loss) and a 3-day bladder diary (frequency of stress incontinence episodes). Additional outcome measures were health-related quality of life measured with the Incontinence Quality of Life (I-QOL) questionnaire, sexual function evaluated via the Female Sexual Function Index (FSFI), and pelvic floor muscle contraction force measured via a perineometer and Modified Oxford Scale (MOS). All participants underwent biofeedback-enhanced pelvic floor muscle training using EMG during 20-minute sessions twice weekly for a period of 8 weeks. In addition to the EMG-BF+ExMI group, ExMI was applied during 20-minute sessions twice weekly for a period of 8 weeks. Participants from both groups were asked to perform pelvic floor muscle exercises at home (60 pelvic floor muscle contractions daily, divided into 3 sessions of 20 contractions each). Outcome measures were made at baseline and repeated at the end of treatment. RESULTS: Fifteen (57.7%) in the EMG-BF group and 13 (52.0%) in the EMG-BF+ExMI group achieved dryness. Four participants (15.4%) in the EMG-BF group and 5 (20%) in the EMG-BF+ExMI group expedenced improvement. Seven patients (26.9%) in the EMG-BF group and 7 (28%) in the EMG-BF+ ExMI group did not benefit from the treatments. There was no statistically significant difference between the groups in terms of cure and improvement F = 0.895). CONCLUSIONS: Findings indicate that use of magnetic innervation does not improve lower urinary tract symptoms, health-related quality of life, sexual function, and pelvic floor muscle strength when compared to pelvic floor muscle training alone.

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