The MAPP research network: Design, patient characterization and operations

The MAPP Research Network Study Group

Research output: Contribution to journalArticle

72 Citations (Scopus)

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)".

Original languageEnglish (US)
Article number58
JournalBMC Urology
Volume14
Issue number1
DOIs
StatePublished - 2014

Fingerprint

Pelvic Pain
Chronic Pain
Research Design
Epidemiology
National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
Research
Clinical Trials
Interstitial Cystitis
Prostatitis
Chronic Fatigue Syndrome
Functional Neuroimaging
Symptom Assessment
Neurobiology
Irritable Bowel Syndrome
Neuroimaging
Internet
Observational Studies
Longitudinal Studies
Patient Care
Animal Models

Keywords

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

ASJC Scopus subject areas

  • Reproductive Medicine
  • Urology

Cite this

The MAPP research network : Design, patient characterization and operations. / The MAPP Research Network Study Group.

In: BMC Urology, Vol. 14, No. 1, 58, 2014.

Research output: Contribution to journalArticle

The MAPP Research Network Study Group. / The MAPP research network : Design, patient characterization and operations. In: BMC Urology. 2014 ; Vol. 14, No. 1.
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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. 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){"}.",
keywords = "Chronic prostatitis, Interstitial cystitis, Neuroimaging, Non-urologic associated syndromes, Plasma biomarkers, Quantitative sensory testing (QST), Urine biomarkers, Urologic chronic pelvic pain syndromes",
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T2 - Design, patient characterization and operations

AU - The MAPP Research Network Study Group

AU - Landis, J. Richard

AU - Williams, David A.

AU - Lucia, M. Scott

AU - Clauw, Daniel J.

AU - Naliboff, Bruce D.

AU - Robinson, Nancy A.

AU - Van Bokhoven, Adrie

AU - Sutcliffe, Siobhan

AU - Schaeffer, Anthony J.

AU - Rodriguez, Larissa V.

AU - Mayer, Emeran A.

AU - Lai, H. Henry

AU - Krieger, John N.

AU - Kreder, Karl J.

AU - Afari, Niloofar

AU - Andriole, Gerald L.

AU - Bradley, Catherine S.

AU - Griffith, James W.

AU - Klumpp, David J.

AU - Hong, Barry A.

AU - Lutgendorf, Susan K.

AU - Buchwald, Dedra

AU - Yang, Claire C.

AU - Mackey, Sean

AU - Pontari, Michel A.

AU - Hanno, Philip

AU - Kusek, John W.

AU - Mullins, Chris

AU - Clemens, J. Quentin

AU - Kirkali, Ziya

AU - Farmer, Melissa A.

AU - Fitzgerald, Colleen

AU - Cella, David

AU - Heckman, Charles J.

AU - Jiang, Mingchen

AU - Keefer, Laurie

AU - Marko, Darlene S.

AU - Michniewicz, Jean

AU - Parrish, Todd

AU - Tu, Frank

AU - Alger, Jeffry

AU - Ashe-McNalley, Cody P.

AU - Ellingson, Ben

AU - Heendeniya, Nuwanthi

AU - Kilpatrick, Lisa

AU - Kutch, Jason

AU - Labus, Jennifer S.

AU - Randal, Fornessa

AU - Smith, Suzanne R.

AU - Hooton, Thomas

PY - 2014

Y1 - 2014

N2 - 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)".

AB - 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)".

KW - Chronic prostatitis

KW - Interstitial cystitis

KW - Neuroimaging

KW - Non-urologic associated syndromes

KW - Plasma biomarkers

KW - Quantitative sensory testing (QST)

KW - Urine biomarkers

KW - Urologic chronic pelvic pain syndromes

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