Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Data Coordinating Center

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Project Summary In the Continuation of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN II), the investigators will advance the subtyping of study participants with Lower Urinary Tract Symptoms (LUTS) with the expectation that clinically useful patient subtypes will be identified. Research efforts will include continued analysis of data and biospecimens from LURN I and development of additional, new and novel collaborative studies to further improve our understanding of lower urinary tract dysfunction, both designed to generate findings that may inform future clinical studies (e.g., clinical treatment trials) and ultimately improve clinical management and patient outcomes. Studies will also refine and evaluate the longitudinal performance of clusters identified in LURN I for patient subtyping, including response to treatment. We will incorporate insights from the LURN I organ-based diagnostics pilot study and biomarker pilot studies. We will evaluate the LURN Comprehensive Assessment of Self-reported Urinary Symptoms (CASUS) instrument in populations with lesser severity of LUTS than seen in the tertiary care setting in LURN I. Consistent with the description in the RFA for this second funding cycle of LURN, the primary goal of this proposal is to better define clinical phenotypes of patients with LUTS, to better describe the impact and diversity of symptoms, and to develop new patient-centric tools for improved measurement of clinical symptoms, all with the goals of informing future clinical studies and improving patient care and outcomes. It is anticipated that the network will consist of up to six clinical sites and a single data coordinating center (DCC). The DCC for the LURN study is charged with providing coordination, communications and logistical support, clinical study design, centralized data management, biosample management, quality assurance, and analytical support to the research sites and the NIDDK Project Scientist for all LURN studies. The proposing team is submitting this response to RFA-DK-18-511 to continue as the DCC for the network.