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BMC Urology
Published in: BMC Urology 1/2014

Open Access 01-12-2014 | Study protocol

The MAPP research network: design, patient characterization and operations

Authors: J Richard Landis, David A Williams, M Scott Lucia, Daniel J Clauw, Bruce D Naliboff, Nancy A Robinson, Adrie van Bokhoven, Siobhan Sutcliffe, Anthony J Schaeffer, Larissa V Rodriguez, Emeran A Mayer, H Henry Lai, John N Krieger, Karl J Kreder, Niloofar Afari, Gerald L Andriole, Catherine S Bradley, James W Griffith, David J Klumpp, Barry A Hong, Susan K Lutgendorf, Dedra Buchwald, Claire C Yang, Sean Mackey, Michel A Pontari, Philip Hanno, John W Kusek, Chris Mullins, J Quentin Clemens, The MAPP Research Network Study Group

Published in: BMC Urology | Issue 1/2014

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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
Appendix
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Metadata
Title
The MAPP research network: design, patient characterization and operations
Authors
J Richard Landis
David A Williams
M Scott Lucia
Daniel J Clauw
Bruce D Naliboff
Nancy A Robinson
Adrie van Bokhoven
Siobhan Sutcliffe
Anthony J Schaeffer
Larissa V Rodriguez
Emeran A Mayer
H Henry Lai
John N Krieger
Karl J Kreder
Niloofar Afari
Gerald L Andriole
Catherine S Bradley
James W Griffith
David J Klumpp
Barry A Hong
Susan K Lutgendorf
Dedra Buchwald
Claire C Yang
Sean Mackey
Michel A Pontari
Philip Hanno
John W Kusek
Chris Mullins
J Quentin Clemens
The MAPP Research Network Study Group
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2014
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/1471-2490-14-58

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