Clinical Effectiveness of Non-invasive Biofeedback for Stress Urinary Incontinence in Women: Preliminary Results of a Randomized Controlled Trial

Research

Objectives: To investigate the preliminary effects of non-invasive biofeedback-assisted pelvic floor muscle training (PFMT) compared to unassisted PFMT for managing symptoms of stress urinary incontinence (SUI) in women.

Design: A two-arm, parallel-group randomized controlled trial.

Setting: The study included women from the public, community centres in Hong Kong, and Kwong Wah Hospital.

Participants: Non-pregnant women aged 35 to 65 years and having mild to moderate SUI or stress-predominant mixed urinary incontinence (MUI) were included in the study. Obese women (body mass index ≥30), women in the postpartum stage of less than six months, and women with complicated SUI, urge predominant MUI, or urge urinary incontinence were excluded from the study. Women who met the eligibility criteria were randomly assigned to two groups: the non-invasive biofeedback-assisted PFMT group (experimental group) or the unassisted PFMT group (control group).

Interventions: Both groups received supervised interventions for 30 minutes weekly for one month. For the supervised training, participants performed PFMT exercises with or without the biofeedback device, according to group assignment.

Main Outcome Measures: The primary outcome was SUI symptom severity, measured using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Secondary outcomes included the severity of urine leakage and PFM strength as measured using the one-hour (1-h) pad test and Modified Oxford Scale (MOS), respectively. Outcomes assessments were completed at baseline and one-month post-intervention.

Results: Twelve women were randomly allocated to receive non-invasive biofeedback plus PFMT (n = 6) or unassisted PFMT (n = 6). The between-group analysis of ICIQ-SF scores revealed a significant effect of non-invasive biofeedback-assisted PFMT compared to unassisted PFMT at one month (p < 0.05). However, for PFM strength, no significant effect of the intervention (non-invasive biofeedback-assisted PFMT) was observed at one month (p > 0.05). The between-group analysis of the 1-hour pad test scores revealed a significant effect of non-invasive biofeedback-assisted PFMT compared to unassisted PFMT at one month (p ≤ 0.05). The effect size at one-month post-intervention for ICIQ-SF and the 1-hour pad test was small.

Conclusions: The preliminary results of this study show that the non-invasive biofeedback device is more effective than unassisted PFMT in improving the symptoms of SUI in women. Non-invasive biofeedback-assisted PFMT was found to have superior benefits over unassisted PFMT for managing SUI in women.

Funding: Health and Medical Research Fund, Food and Health Bureau, Hong Kong SAR Government (#20211081).

Author(s) Disclosures: Authors declare that there are no conflicts of interest.