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

Peter Rosenblatt, Jessica McKinney, Robert A Rosenberg, Raymon J Iglesias, Robin C Sutherland, Samantha J Pulliam, Peter Rosenblatt, Jessica McKinney, Robert A Rosenberg, Raymon J Iglesias, Robin C Sutherland, Samantha J Pulliam

Abstract

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.

Keywords: biofeedback; pelvic digital health system; pelvic floor muscle training; urinary incontinence.

© 2019 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
The leva Pelvic Digital Health System components and Visual Interface. A, The system consists of an intravaginal sensor and a battery‐powered Bluetooth transmitter that sends visual output to the user's smartphone. B, The system provides real‐time PFM training coaching to the participant using a graphic assessment of the pelvic floor angle achieved and duration of each contraction, and (C) stores these data in a training history file that is accessible by the user and, with permission, her health care provider. The system also provides pictorial examples of pelvic floor functional anatomy during properly and improperly performed muscle contractions to help the user visualize and reinforce correct pelvic muscle action during training (not shown). PFM, pelvic floor muscle
Figure 2
Figure 2
Incontinence symptoms and condition‐specific quality‐of‐life measures. Mean values ± SEM for each UI‐specific questionnaire are illustrated. A significant linear trend from baseline through 6 weeks was identified for each measure. SEM, standard error of the mean; UDI‐6, urogenital distress inventory; UI, urinary incontinence
Figure 3
Figure 3
Objective measures of PFM function. Mean values for PFM objective measurements include (A) maximum contraction duration, (B) the maximum number of repeated contractions in 15 seconds, and (C) pelvic floor angle relative to the earth with maximal effort contraction. PFM, pelvic floor muscle

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