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.