Risk determination and prognostication for older and frail older adults undergoing advanced treatments for overactive bladder

PROJECT ABSTRACT / SUMMARY There is a fundamental gap in our understanding of outcomes related to third-line treatments [onabotulinumtoxinA, peripheral tibial nerve stimulation (PTNS), and sacral neuromodulation] for refractory overactive bladder (OAB) in older and frail older adults, who collectively comprise the majority of patients suffering from this condition. Despite being well-studied in young and middle-aged healthy adults, little is known about outcomes and complications of these treatments in these more vulnerable populations, potentially resulting in overutilization of treatments that are ineffective or dangerous, or in underutilization of treatments that may significantly improve health related quality of life. Our overarching research objective is to improve care for all older and frail older adults undergoing treatment for OAB. The objective of this proposed study is to better understand the utilization, outcomes and complications associated with onabotulinumtoxinA, PTNS, and sacral neuromodulation in older and frail older adults, and to use this information to create an individualized and actionable prognostic tool. The central hypothesis is that utilization of these procedures may be biased towards younger aged individuals (of white race and higher socioeconomic status, performed by high volume specialists), regardless of level of frailty, but that frailty will be highly correlated with poor outcomes and increased rates of complications. We will test this hypothesis by leveraging a 100% cohort of fee-for-service Medicare beneficiaries undergoing these procedures and the claims based frailty index (CFI), as the measure of frailty, by the following three aims: (1) to understand the utilization of invasive OAB treatments (a) according to age and frailty, and (b) according to other non-clinical factors: patient (race/ethnicity), regional (socioeconomic) and provider (surgeon and volume); (2) to determine downstream outcomes and utilization of third-line OAB treatments across the spectrum of advancing age and frailty up to 2 years after the procedure; (3) to develop and internally validate a prognostic tool to predict successful outcomes for older and frail older adults undergoing third-line OAB treatments. This study is innovative because it will measure and apply the important factor of frailty to a national cohort of 100% of fee-for-service Medicare beneficiaries undergoing onabotulinumtoxinA, PTNS, and sacral neuromodulation to ultimately create an individualized prognostic tool to improve outcomes in this understudied population. The proposed research is significant because there is a critical lack of information about outcomes for refractory OAB in this large and vulnerable population who suffer greatly from this condition. Development of an individualized prognostic tool to aid in this decision-making process will serve to minimize the risks of potentially unsuccessful, unnecessary and even harmful procedures, while promoting the use of such procedures among individuals who are more likely to receive benefit.