Real-Time Classification of Bladder Events for Effective Diagnosis and Treatment of Urinary Incontinence

Diagnosis of lower urinary tract dysfunction with urodynamics has historically relied on data acquired from multiple sensors using nonphysiologically fast cystometric filling. In addition, state-of-the-art neuromodulation approaches to restore bladder function could benefit from a bladder sensor for closed-loop control, but a practical sensor and automated data analysis are not available. We have developed an algorithm for real-time bladder event detection based on a single in situ sensor, making it attractive for both extended ambulatory bladder monitoring and closed-loop control of stimulation systems for diagnosis and treatment of bladder overactivity. Using bladder pressure data acquired from 14 human subjects with neurogenic bladder, we developed context-aware thresholding, a novel, parameterized, user-tunable algorithmic framework capable of real-time classification of bladder events, such as detrusor contractions, from single-sensor bladder pressure data. We compare six event detection algorithms with both single-sensor and two-sensor systems using a metric termed Conditional Stimulation Score, which ranks algorithms based on projected stimulation efficacy and efficiency. We demonstrate that adaptive methods are more robust against day-to-day variations than static thresholding, improving sensitivity and specificity without parameter modifications. Relative to other methods, context-aware thresholding is fast, robust, highly accurate, noise-tolerant, and amenable to energy-efficient hardware implementation, which is important for mapping to an implant device.