TY - JOUR
T1 - The LURN Research Network Neuroimaging and Sensory Testing (NIST) Study
T2 - Design, protocols, and operations
AU - the LURN Study Group
AU - Henry Lai, H.
AU - Naliboff, Bruce
AU - Liu, Alice B.
AU - Amundsen, Cindy L.
AU - Shimony, Joshua S.
AU - Magnotta, Vincent A.
AU - Shaffer, Joseph J.
AU - Gilliam, Robin L.
AU - Wiseman, Jonathan B.
AU - Helmuth, Margaret E.
AU - Andreev, Victor P.
AU - Kirkali, Ziya
AU - Harte, Steven E.
N1 - Funding Information:
Steven E. Harte reports grants from the NIH for the conduct of this study. In addition, Dr. Harte is co-inventor with royalty rights on the patent for the MAST pain testing device (US 9307906) used in this study, and he has equity membership with Arbor Medical Innovations (Ann Arbor, MI), the licensee of this technology. Steven E. Harte reports grants from NIH, VA, Cerephex, Eli Lilly, American Cancer Society, AAOGF; grants and personal fees from Aptinyx; personal fees from SUFU and Longitudinal Capital Management; personal fees and non-financial support from University of North Carolina - Chapel Hill, all outside the submitted work.
Funding Information:
Arbor Research Collaborative for Health, Data Coordinating Center (DK097776 and DK099879): PI: Robert Merion, MD, FACS; Co-Is: Victor Andreev, PhD, DSc, Brenda Gillespie, PhD, Gang Liu, PhD, Abigail Smith, PhD; Project Manager: Melissa Fava, MPA, PMP; Clinical Study Process Manager: Peg Hill-Callahan, BS, LSW; Clinical Monitor: Timothy Buck, BS, CCRP; Research Analysts: Margaret Helmuth, MA, Jon Wiseman, MS; Project Associate: Julieanne Lock, MLitt.
Funding Information:
Research reported in this publication was supported at Northwestern University , in part, by the National Institutes of Health’s National Center for Advancing Translational Sciences , Grant Number UL1TR001422 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health .
Funding Information:
This study is supported by the National Institute of Diabetes and Digestive and Kidney Diseases through cooperative agreements (grants DK097780 , DK097772 , DK097779 , DK099932 , DK100011 , DK100017 , DK097776 , DK099879 ).
Funding Information:
Dr. Siddiqui is supported by grant K23-DK110417 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Publisher Copyright:
© 2018
PY - 2018/11
Y1 - 2018/11
N2 - 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.
AB - 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.
KW - Functional MRI
KW - Lower urinary tract symptoms
KW - Overactive bladder
KW - Quantitative sensory testing
KW - Urgency incontinence
UR - http://www.scopus.com/inward/record.url?scp=85054724035&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2018.09.010
DO - 10.1016/j.cct.2018.09.010
M3 - Article
C2 - 30248454
AN - SCOPUS:85054724035
SN - 1551-7144
VL - 74
SP - 76
EP - 87
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -