Lower urinary tract dysfunction (LUTD) is prevalent and is associated with significant suffering among men and women. Included in the definition of LUTD are all urinary symptoms of storage, voiding, incontinence, and post micturition. Evidence-based treatment guidelines are desperately needed to help clinicians and patients select the most effective treatments. However, the research to support such guidelines is hampered in part by (1) a lack of comprehensive, high-quality patient-reported measures of LUTD symptoms, and (2) a clear understanding of the phenotypes associated with LUTD and biomarkers that could help to predict and explain their occurrence. To begin to address these limitations, the National Institute of Diabetes and Digestive and Kidney Diseases is establishing the Symptoms of Lower Urinary Tract Dysfunction Research Network, or LURN (RFA-DK-11-026). Our objective is to work as a Research Site within LURN to produce high quality patient-reported measures of LUTD symptoms and use these new measures in exploratory studies to advance our understanding of LUTD and its treatment. We will achieve this objective by pursuing the following 3 Specific Aims: (1) To develop patient-reported measures of LUTD symptoms in men and women. (2) To evaluate the validity of new patient-reported measures of LUTD symptoms for use in specific clinical populations. (3) To explore the phenotypes and causes of LUTD using newly developed patient-reported outcome measures, clinical data, and novel biomarkers. To achieve these aims within the context of the network, we will work collaboratively with the other LURN sites and the data-coordinating center following protocols agreed upon by LURN Steering Committee. At the completion of this 5-year project, we and our LURN Network collaborators will have produced a set of valid, responsive measures of the symptoms of LUTD and explored the contribution of such measures to efforts to better classify subgroups of patients suffering from LUTD.

Public Health Relevance

Our project will use the improved PRO measurements and correlate them with the established testing measures of urodynamics and bladder diaries, thus potentially avoiding unnecessary tests in the future. Using preclinical data, we hope to further distinguish the most common clinical LUTD phenotypes using additional physiological and clinical biomarkers. By better understanding the pathophysiology of each phenotype, we may better individualize therapy as well as develop more effective treatments, which will enhance the lives of patients with LUTD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK097780-04
Application #
8877500
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
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
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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
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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
Yang, Claire C; Weinfurt, Kevin P; Merion, Robert M et al. (2016) Symptoms of Lower Urinary Tract Dysfunction Research Network. J Urol 196:146-52