Home-based noninvasive pelvic floor muscle training device to assist women in performing Kegel exercise in the management of stress urinary incontinence

Background: Stress urinary incontinence (SUI) is a major health problem affecting approximately 50% of the female population over 45 years of age. We evaluated the therapeutic effects of a home-based non-invasive wireless sensor pelvic floor muscle training (PFMT) device with assisted Kegel exercise for SUI. Methods: We included 60 women 40 to 60 years of age who were diagnosed with urodynamic SUI (mean pad test, 10.52 g). The PFMT device applicator was clamped on the upper inner thigh, and the patients could self-train at home. The signal was recorded and delivered to a 3G/4G smartphone via Bluetooth, which also allows guided feedback via the smartphone’s voice. To evaluate the therapeutic effect, all patients completed the following questionnaires: a 3-day bladder diary, the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the Urogenital Distress Inventory-Short Form, and the Incontinence Impact Questionnaire-7 (IIQ-7). One-hour pad test measurements were performed before the test (M0) and at 1 (M1), 2 months (M2), and 3 months (M3) after the PFMT device-assisted Kegel exercise. Results: The 1-hour pad test and the scores of the ICIQ-SF, UDI-6, and IIQ-7 questionnaires were improved at M1, M2, and M3, compared with the M0 values. The mean value of the post-voiding residual urine (PVR) significantly decreased at M2 and M3. The subjective and objective improvement rates at M3 were 80% and 72%, respectively. Conclusion: The data demonstrated that 3 months of Kegel exercise assisted with a home-based PFMT device improved the number and severity of episodes, PVR, and quality of life in patients with SUI, suggesting that this device might serve as an alternative non-invasive therapy for mild and moderate SUI.