Lower urinary tract dysfunction (LUTD) is common, and its incidence and prevalence are increasing as the population ages. Symptoms of LUTD are costly to diagnose and treat; existing therapeutic interventions are neither highly effective nor durable and have side effects of their own. Not surprisingly, unsatisfactory outcomes from the patient perspective are common. Collectively, these challenges represent important targets of research that are consistent with the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Previous efforts to improve patient reported outcomes (PRO) in this area have relied on incomplete symptom measurement scales and have been hampered by imperfect understanding of the origin and natural history of LUTD. Comprehensive re-evaluation of the symptom universe of LUTD and more precise characterization of patients with symptoms of LUTD (phenotyping) may provide significant new insights, leading ultimately to improved patient lives. The NIDDK-sponsored Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) includes a Data Coordinating Center (DCC) to serve as the project and data management nexus for the network. The purpose of this project is to establish the DCC, which will form a collaborative relationship with NIDDK and several clinical sites that will enroll patiets with symptoms of LUTD into carefully designed studies. There are two specific aims. The first is to develop the infrastructure to support the entire research network. This will include expertise and experience in the areas of research coordination, communications and logistics, study design, database design and centralized data management, study monitoring, quality assurance, biosample handling and tracking, and recognized excellence in the application of a wide range of statistically rigorous analysis methods. The second specific aim embodies the scientific goals of the project, including: 1) development of PRO measurement tools to quantitate symptoms of LUTD in women and men using state-of-the-art scale development and statistical analysis methods; 2) development of deep phenotyping of patient cohorts with relevant LUTD symptoms using cluster analysis, classification and regression trees, and other data mining methods; and 3) identification of biomarkers related to symptom initiation, exacerbation, mitigation, remission, and progression.

Public Health Relevance

The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) will study people who have symptoms of lower urinary tract dysfunction (LUTD). The scientific collaborators will ask patients to participate in studies that will include he development of surveys to help patients to better explain their symptoms and to communicate how much those symptoms affect their lives. The scientists will also develop symptom profiles that will help doctors better diagnose and treat the symptoms of LUTD. Finally, the researchers will try to determine whether there are substances in blood or urine that can help improve our understanding of these symptoms and the diseases that cause them.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK097776-04
Application #
8877498
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Kirkali, Ziya
Project Start
2012-09-30
Project End
2016-05-31
Budget Start
2015-06-01
Budget End
2016-05-31
Support Year
4
Fiscal Year
2015
Total Cost
Indirect Cost
Name
Arbor Research Collaborative for Health
Department
Type
DUNS #
364217265
City
Ann Arbor
State
MI
Country
United States
Zip Code
48104
Helfand, Brian T; Smith, Abigail R; Lai, H Henry et al. (2018) Prevalence and Characteristics of Urinary Incontinence in a Treatment Seeking Male Prospective Cohort: Results from the LURN Study. J Urol 200:397-404
Andreev, Victor P; Liu, Gang; Yang, Claire C et al. (2018) Symptom Based Clustering of Women in the LURN Observational Cohort Study. J Urol 200:1323-1331
Cameron, Anne P; Lewicky-Gaupp, Christina; Smith, Abigail R et al. (2018) Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study. J Urol 199:1023-1031
Griffith, James W; Messersmith, Emily E; Gillespie, Brenda W et al. (2018) Reasons for Seeking Clinical Care for Lower Urinary Tract Symptoms: A Mixed Methods Study. J Urol 199:528-535
Helmuth, Margaret E; Smith, Abigail R; Andreev, Victor P et al. (2018) Use of Euclidean length to measure urinary incontinence severity based on the lower urinary tract symptoms tool. Am J Obstet Gynecol 218:357-359
Lai, H Henry; Naliboff, Bruce; Liu, Alice B et al. (2018) The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study: Design, protocols, and operations. Contemp Clin Trials 74:76-87
Siddiqui, Nazema Y; Wiseman, Jonathan B; Cella, David et al. (2018) Mental Health, Sleep and Physical Function in Treatment Seeking Women with Urinary Incontinence. J Urol 200:848-855
Cameron, Anne P; Smith, Abigail R; Lai, H Henry et al. (2018) Bowel function, sexual function, and symptoms of pelvic organ prolapse in women with and without urinary incontinence. Neurourol Urodyn 37:2586-2596
Bradley, Catherine S; Erickson, Bradley A; Messersmith, Emily E et al. (2017) Evidence of the Impact of Diet, Fluid Intake, Caffeine, Alcohol and Tobacco on Lower Urinary Tract Symptoms: A Systematic Review. J Urol 198:1010-1020
Andreev, Victor P; Gillespie, Brenda W; Helfand, Brian T et al. (2016) Misclassification Errors in Unsupervised Classification Methods. Comparison Based on the Simulation of Targeted Proteomics Data. J Proteomics Bioinform Suppl 14:

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