The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study: Design, protocols, and operations

The Neuroimaging and Sensory Testing (NIST) Study of the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) is a cross-sectional, case-control study designed to investigate whether disrupted brain connectivity and sensory processing are associated with abnormal lower urinary tract symptoms (LUTS) in patients with overactive bladder syndrome (OAB). The NIST Study tests the hypotheses that patients with urinary urgency will demonstrate: (1) abnormal functional and structural connectivity of brain regions involved in urinary sensation on magnetic resonance imaging (MRI), and (2) hypersensitivity to painful (pressure) and non-painful (auditory) sensory stimuli on quantitative sensory testing (QST), compared to controls. Male and female adults (18 years or older) who present at one of the six participating LURN clinical centers for clinical care of their LUTS, with symptoms of urinary urgency with or without urgency urinary incontinence, are eligible to participate. The NIST Study is the largest MRI and QST study of its kind, yielding a neuroimaging and sensory testing dataset unprecedented in OAB research. Advanced multi-modal techniques are used to understand brain functional and structural connectivity, including gray matter volume, and sensory function. Unlike previous MRI studies which involved invasive catheterization and repeated cycles of non-physiologic bladder filling and emptying via a catheter, we use a water ingestion protocol to mimic more physiological bladder filling through natural diuresis. Furthermore, these data will be used in concert with other phenotyping data to improve our understanding of clinically meaningful subtypes of patients with LUTS in order to improve patient care and management outcomes.

Contemporary clinical trials. 2018 Sep 21 [Epub]

H Henry Lai, Bruce Naliboff, Alice B Liu, Cindy L Amundsen, Joshua S Shimony, Vincent A Magnotta, Joseph J Shaffer, Robin L Gilliam, Jonathan B Wiseman, Margaret E Helmuth, Victor P Andreev, Ziya Kirkali, Steven E Harte, LURN Study Group

Departments of Surgery (Urology) and Anesthesiology, Washington University in St. Louis, St. Louis, MO, United States. Electronic address: ., Departments of Medicine and Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, CA, United States., Department of Urology, University of Washington, Seattle, WA, United States., Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC, United States., Mallinckrodt Institute of Radiology, Washington University in St Louis, St. Louis, MO, United States., Department of Radiology, University of Iowa, Iowa City, IA, United States., Arbor Research Collaborative for Health, Ann Arbor, MI, United States., National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, United States., Departments of Anesthesiology and Internal Medicine-Rheumatology, University of Michigan, Ann Arbor, MI, United States.