LURN II: Enhanced Characterization of Patients with LUTS Using Biopsychosocial Approaches

ABSTRACT This application is in response to PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). Summary of parent-award Specific Aims. The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was assembled in 2012 to increase the understanding of lower urinary tract symptoms (LUTS). Related to this

goal was the improvement of patient-centered assessment of LUTS. This work involves improving the self-report measurement of LUTS using new, high-quality items to be used in questionnaire assessments. These items were created with qualitative input from patients, community participants, internists, urologists, urogynecologists, and clinical researchers. This set of items is referred to as the

Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS). The original aims of the grant were Aim 1: To refine and expand a clinically-relevant cluster model across a cohort of patients with LUTS. Relative to LURN I, participants will have a wider range of symptom severity and be characterized using novel measures of bladder and urethral function; Aim 2: To identify protein

biomarker signatures contained within plasma of specific subgroups of men and women with LUTS; Aim 3: To determine phenotypic characteristics of women with LUTS by measuring the functional components of the lower urinary tract; Aim 4 To validate comprehensive outcome tools for men and women with LUTS; and Aim 5: To determine influences of stress and mental health on LUTS. In this

supplement, we will focus on the following additional activities: Aim 5.1. Determine the relationship between level of cognitive function and LUTS. LUTS increase with age and are associated with greater impairment in performing activities of daily living, lower mood, and poorer overall health quality. More

recently, LUTS have been associated with increased risk of cognitive impairment and dementia. The LURN II data present a unique opportunity to further elucidate the relationship between cognition and LUTS. Within Aim 5.1, our hypothesis is: Cognitive function, measured by BrainTest, which is based on

the electronic version of the self-administered gerocognitive examination (eSAGE), will be related to LUTS; Aim 5.2. Determine baseline predictors of LUTS trajectories in a sample of men and women with urinary urgency. We will conduct separate analyses in men and women who have urinary urgency and other LUTS. We propose to create models of the trajectory of LUTS for each participant, and then

relating these trajectories to patient health variables. We will explore baselines symptoms, combined with other health variables that have been explored in LURN I such as BMI, depression, anxiety, and sleep disturbance. We also plan to explore psychosocial variables that have not been explored with respect to

urgency: intolerance of uncertainty, catastrophizing, and adverse childhood experiences.