The MAPP research network: design, patient characterization and operations

BMC Urology

Study Protocol

Sean Mackey¹  J Richard Landis²  Nancy A Robinson²  James W Griffith³  Adrie van Bokhoven⁴  M Scott Lucia⁴  J Quentin Clemens⁵  Anthony J Schaeffer⁶  David J Klumpp⁶  Philip Hanno⁷  Michel A Pontari⁸  Karl J Kreder⁹  Larissa V Rodriguez^1,10  John N Krieger^1,11  Claire C Yang^1,11  David A Williams^1,12  Daniel J Clauw^1,12  Dedra Buchwald^1,13  Bruce D Naliboff^1,14  Catherine S Bradley^1,15  Susan K Lutgendorf^1,15  Barry A Hong^1,16  Emeran A Mayer^1,17  Siobhan Sutcliffe^1,18  H Henry Lai^1,19  Gerald L Andriole^1,19  John W Kusek^2,20  Chris Mullins^2,20  Niloofar Afari^2,21 

[1] Department of Anesthesiology, Division of Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, USA;Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA;Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA;Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA;Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA;Department of Urology, Northwestern University, Chicago, IL, USA;Department of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA;Department of Urology, Temple University School of Medicine, Philadelphia, PA, USA;Department of Urology, University of Iowa, Iowa City, IA, USA;Department of Urology, University of Southern California, Beverly Hills, CA, USA;Department of Urology, University of Washington, Seattle, WA, USA;Departments of Anesthesiology, Medicine and Psychiatry, University of Michigan, Ann Arbor, MI, USA;Departments of Epidemiology and Medicine, University of Washington, Seattle, WA, USA;Departments of Medicine, Psychiatry, and Gastroenterology, University of California, Los Angeles, CA, USA;Departments of Obstetrics and Gynecology, Urology and Epidemiology, University of Iowa, Iowa City, IA, USA;Departments of Psychiatry and Medicine, Washington University School of Medicine, St. Louis, MO, USA;Division of Digestive Diseases, University of California, Los Angeles, CA, USA;Division of Public Health Sciences, Department of Surgery, Washington University, St Louis, MO, USA;Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA;National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA;VA Center of Excellence for Stress and Mental Health, University of California San Diego, San Diego, CA, USA;

关键词: Urologic chronic pelvic pain syndromes;    Interstitial cystitis;    Chronic prostatitis;    Urine biomarkers;    Plasma biomarkers;    Non-urologic associated syndromes;    Quantitative sensory testing (QST);    Neuroimaging;   

DOI  :  10.1186/1471-2490-14-58

 received in 2014-06-13, accepted in 2014-07-23,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundThe “Multidisciplinary Approach to the Study of Chronic Pelvic Pain” (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network’s central study and common data elements are described.MethodsThe primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as “positive” controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing.DiscussionThe MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based.Trial registrationClinicalTrials.gov identifier: NCT01098279 “Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)”. http://clinicaltrials.gov/show/NCT01098279

【 授权许可】

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© Landis et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.