title: The MAPP research network: design, patient characterization and operations.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors.forename: J Richard
authors.initials: JR
authors.lastname: Landis
authors.forename: David A
authors.initials: DA
authors.lastname: Williams
authors.forename: M Scott
authors.initials: MS
authors.lastname: Lucia
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Clauw
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Naliboff
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Robinson
authors.forename: Adrie
authors.initials: A
authors.lastname: van Bokhoven
authors.forename: Siobhan
authors.initials: S
authors.lastname: Sutcliffe
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Schaeffer
authors.forename: Larissa V
authors.initials: LV
authors.lastname: Rodriguez
authors.forename: Emeran A
authors.initials: EA
authors.lastname: Mayer
authors.forename: H Henry
authors.initials: HH
authors.lastname: Lai
authors.forename: John N
authors.initials: JN
authors.lastname: Krieger
authors.forename: Karl J
authors.initials: KJ
authors.lastname: Kreder
authors.forename: Niloofar
authors.initials: N
authors.lastname: Afari
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: Catherine S
authors.initials: CS
authors.lastname: Bradley
authors.forename: James W
authors.initials: JW
authors.lastname: Griffith
authors.forename: David J
authors.initials: DJ
authors.lastname: Klumpp
authors.forename: Barry A
authors.initials: BA
authors.lastname: Hong
authors.forename: Susan K
authors.initials: SK
authors.lastname: Lutgendorf
authors.forename: Dedra
authors.initials: D
authors.lastname: Buchwald
authors.forename: Claire C
authors.initials: CC
authors.lastname: Yang
authors.forename: Sean
authors.initials: S
authors.lastname: Mackey
authors.forename: Michel A
authors.initials: MA
authors.lastname: Pontari
authors.forename: Philip
authors.initials: P
authors.lastname: Hanno
authors.forename: John W
authors.initials: JW
authors.lastname: Kusek
authors.forename: Chris
authors.initials: C
authors.lastname: Mullins
authors.affiliation: Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA. qclemens@med.umich.edu.
authors.forename: J Quentin
authors.initials: JQ
authors.lastname: Clemens
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration*; D002908:Chronic Disease; D018856:Cystitis, Interstitial / Q000503:physiopathology; D005260:Female; D006801:Humans; D033183:Interdisciplinary Communication; D008137:Longitudinal Studies; D008297:Male; D054586:National Institute of Diabetes and Digestive and Kidney Diseases (U.S.); D017699:Pelvic Pain / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology*; D010641:Phenotype; D011446:Prospective Studies; D011472:Prostatitis / Q000503:physiopathology; D012107:Research Design; D013577:Syndrome; D014481:United States
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