Evaluation of an accelerometer-based digital health system for the treatment of female urinary incontinence: A pilot study.

AIMS

To assess the effectiveness and patient satisfaction of pelvic floor muscle training (PFMT) guided by an intravaginal accelerometer-based system for the treatment of female urinary incontinence (UI).

METHODS

Premenopausal women with mild-to-moderate stress or mixed UI were recruited to participate in PFMT with an accelerometer-based system for 6 weeks with supervision. Objective outcomes included pelvic floor muscle (PFM) contraction duration, number of contractions in 15 seconds, and angular displacement of the accelerometer relative to earth during PFM contraction. Subjective outcomes and quality-of-life were assessed with validated, condition-specific questionnaires. Results are presented as means, standard error of the mean, and 95% confidence intervals unless otherwise indicated.

RESULTS

Twenty-three women (age 42.0 ± 10.7 years, mean ± standard deviation) completed the study. Scores on the Urogenital Distress Inventory (UDI) decreased from 36.7 ± 4.7 at baseline to 1.45 ± 0.8 at 6 weeks (P < .0001). The Patient's Global Impression of Severity score decreased from 1.5 ± 0.1 to 0.2 ± 0.1 (P < .0001) at study endpoint. At 6 weeks, the PFM contraction duration increased from 13 ± 2.6 at baseline to 187 ± 9.6 seconds (P < .0001). Repeated contractions in 15 seconds increased from 5.9 ± 0.4 at enrollment to 9.6 ± 0.5 at 6 weeks (P < .0001). Maximum pelvic floor angle (a measure of lift) increased from 65.1 ± 2.0° to 81.1 ± 1.8° (P < .0001). Increasing PFM contraction duration and maximum pelvic floor angle correlated with decreasing UDI-6 scores, r = -0.87, P = .01; r = -0.97, P = .0003, respectively. No device-related adverse events occurred.

CONCLUSIONS

Pilot testing of this accelerometer-based system demonstrates improvements in objective PFM measures, patient-reported UI severity and condition-specific quality of life, with results evident after 1 week of use.