A novel biofeedback device for urinary incontinence in women: A pilot randomized controlled trial.

Research Objectives: To compare the outcomes of stress urinary incontinence (SUI) treatment through pelvic floor muscle training (PFMT) performed with a newly developed electromyography (EMG) biofeedback device, with conventional EMG biofeedback using a vaginal probe, or without biofeedback.

Design: An assessor-blinded, three-arm, parallel-group, randomized controlled pilot trial.

Setting: The trial was conducted in a hospital (Kwong Wah), two community centers in Hong Kong, and at the Hong Kong Polytechnic University.

Participants: Fifty-one women were included in the trial. Women were included if they were aged 35–60 years and were diagnosed with SUI. Women diagnosed with urge/ mixed incontinence were excluded from the trial.

Interventions: Women with SUI were randomly allocated to the following treatment groups: PMFT with the new biofeedback device (n = 17), PMFT with conventional biofeedback (n = 17), or a PFMT alone (n = 17; standard care control). Study interventions were provided 3 times a week for 4 weeks, followed by unsupervised video-guided home exercises for 12 weeks.

Main Outcome Measures: International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), one-hour pad test, pelvic floor muscle (PFM) strength, and feasibility measures (treatment adherence and safety). Treatment adherence was measured using a 0–10 adherence scale, where 0 indicates low adherence and 10 indicates high adherence.

Results: The between-group analysis revealed statistically significant effects for the new biofeedback compared with the conventional biofeedback and PFMT for improving SUI symptoms (p < 0.01), the severity of urine loss (p < 0.05) and PFM strength (p < 0.05). Treatment adherence was higher in the new biofeedback group than in the conventional and PFMT groups.

Conclusions: The pilot trial found that participants in the new biofeedback device group expressed good device acceptance. PFMT combined with the new biofeedback device was more effective for reducing SUI symptoms in women than PFMT combined with conventional biofeedback or PFMT alone. Results demonstrated good PFMT adherence in the new biofeedback group compared to the conventional biofeedback and PFMT alone groups.

Author(s) Disclosures: None declared.