Advancing sacral neuromodulation with objective analytics and prediction

About This Grant

PROJECT SUMMARY Urinary urgency is the defining symptom in Overactive Bladder (OAB) which affects nearly 25% of the US population and proportionately more women than men. Current treatments for OAB are lacking with the majority of patients quickly withdrawing from drug treatments due to poor efficacy or side effects. When initial treatments fail, appropriate patients may be offered sacral neuromodulation (SNM) which involves implantation of a neurostimulator at the S3 nerve root. The majority of these devices require reprogramming (remotely manipulating the amplitude or lead stimulation pattern) to restore efficacy, thus preventing discontinuation or removal of the expensive device. There are no objective tools to optimize reprogramming, individualize treatments, or predict long-term outcomes with SNM. Currently, pelvic and perineum sensation is the only guiding feature for reprogramming and articulating the location and sensation details to providers in this anatomic area can be difficult. SNM is thought to work by generating signals to interrupt abnormal afferent (toward the brain) neural signals relaying sensations of bladder urgency. Components of this abnormal neurologic response to increases in urinary urgency can be measured in the prefrontal cortex (PFC) of the brain. Functional near-infrared spectroscopy (fNIRS) is a non-invasive tool capable of detecting brain signal changes during increased urgency and SNM programming in the PFC. Therefore, establishment of non-invasive methods with fNIRS to detect real-time neural responses to acute reprogramming, which are then correlated with long- term treatment success, have the potential to transform OAB treatment in terms of efficacy, quality-of-life, and cost-effectiveness. Furthermore, incorporating improved tools for mapping the pelvic and perineal sensation changes during reprogramming can better quantify these sensations and allow for prediction modeling. The proposed research has three aims: (1) To develop novel fNIRS analytics to identify PFC patterns associated with acute SNM adjustments and correlate these patterns with treatment responses (2) To develop an instrument for correlating perineal and pelvic sensation to acute SNM programming and treatment response, (3) To develop a model to predict acute SNM programming responses using clinical, fNIRS, and sensory analytic data. The tools developed in this innovative study will have applications for optimizing treatments in other forms of urgency and voiding dysfunction. The PI, Dr. Burkett, is an Early-Career Investigator and Urogynecologist physician. This career development award will fill gaps in her training necessary for her transition to independence in neuroexcitation research related to bladder and voiding dysfunction. Specifically, Dr. Burkett will seek further structured training and mentorship in fNIRS analysis and application, instrument design and implementation, predictive model computation, professional development, and responsible conduct of research. She will work closely with her multidisciplinary mentorship team to complete her training goals and research aims.