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Open Access Highly Accessed Study protocol

The MAPP research network: design, patient characterization and operations

J Richard Landis1, David A Williams2, M Scott Lucia3, Daniel J Clauw2, Bruce D Naliboff4, Nancy A Robinson1, Adrie van Bokhoven3, Siobhan Sutcliffe5, Anthony J Schaeffer6, Larissa V Rodriguez7, Emeran A Mayer8, H Henry Lai9, John N Krieger10, Karl J Kreder11, Niloofar Afari12, Gerald L Andriole9, Catherine S Bradley13, James W Griffith14, David J Klumpp6, Barry A Hong15, Susan K Lutgendorf13, Dedra Buchwald16, Claire C Yang10, Sean Mackey17, Michel A Pontari18, Philip Hanno19, John W Kusek20, Chris Mullins20, J Quentin Clemens21* and The MAPP Research Network Study Group

Author Affiliations

1 Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA

2 Departments of Anesthesiology, Medicine and Psychiatry, University of Michigan, Ann Arbor, MI, USA

3 Department of Pathology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

4 Departments of Medicine, Psychiatry, and Gastroenterology, University of California, Los Angeles, CA, USA

5 Division of Public Health Sciences, Department of Surgery, Washington University, St Louis, MO, USA

6 Department of Urology, Northwestern University, Chicago, IL, USA

7 Department of Urology, University of Southern California, Beverly Hills, CA, USA

8 Division of Digestive Diseases, University of California, Los Angeles, CA, USA

9 Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA

10 Department of Urology, University of Washington, Seattle, WA, USA

11 Department of Urology, University of Iowa, Iowa City, IA, USA

12 VA Center of Excellence for Stress and Mental Health, University of California San Diego, San Diego, CA, USA

13 Departments of Obstetrics and Gynecology, Urology and Epidemiology, University of Iowa, Iowa City, IA, USA

14 Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA

15 Departments of Psychiatry and Medicine, Washington University School of Medicine, St. Louis, MO, USA

16 Departments of Epidemiology and Medicine, University of Washington, Seattle, WA, USA

17 Department of Anesthesiology, Division of Pain Medicine, Stanford University School of Medicine, Palo Alto, CA, USA

18 Department of Urology, Temple University School of Medicine, Philadelphia, PA, USA

19 Department of Urology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA

20 National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA

21 Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA

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BMC Urology 2014, 14:58  doi:10.1186/1471-2490-14-58

Published: 1 August 2014

Abstract

Background

The “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.

Methods

The 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.

Discussion

The 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 registration

ClinicalTrials.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 webcite

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