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The MAPP research network: design, patient characterization and operations.

Landis JR, Williams DA, Lucia MS, Clauw DJ, Naliboff BD, Robinson NA, van Bokhoven A, Sutcliffe S, Schaeffer AJ, Rodriguez LV, Mayer EA, Lai HH, Krieger JN, Kreder KJ, Afari N, Andriole GL, Bradley CS, Griffith JW, Klumpp DJ, Hong BA, Lutgendorf SK, Buchwald D, Yang CC, Mackey S, Pontari MA, Hanno P, Kusek JW, Mullins C, Clemens JQ, MAPP Research Network Study Gro - BMC Urol (2014)

Bottom Line: 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.An extended follow-up study for 161 of the UCPPS participants is ongoing.The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA. qclemens@med.umich.edu.

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.

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Related in: MedlinePlus

Sequence of Trans-MAPP Epidemiology and Phenotyping (EP) Study Screening, Phenotyping, Biospecimen Collection and Enrollment into the EP Study.
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Figure 4: Sequence of Trans-MAPP Epidemiology and Phenotyping (EP) Study Screening, Phenotyping, Biospecimen Collection and Enrollment into the EP Study.

Mentions: The screening and enrollment process utilized one in-clinic baseline study visit for informed consent and eligibility confirmation. This baseline visit was structured so that essential information, such as brief symptoms analogous to those used in previous UCPPS clinical studies (e.g., pain, pressure, discomfort and sex-specific symptom criteria) [57,58] and a urine sample dipstick could be acquired prior to the conduct of more intensive, invasive and time-consuming procedures (Figure 4). Persons meeting initial eligibility were then invited to complete the Trans-MAPP EP Study assessments, and were enrolled only after a negative 48-hour urine culture report. Eligible participants then underwent extensive baseline characterization using the standardized battery of urologic and non-urologic assessment instruments described previously. Biosamples, QST, and neuroimaging was also collected concurrently with the self-report information at baseline. Healthy controls, as well as “positive” controls (i.e., individuals with one or more non-urologic associated syndromes of primary interest; Table 2), were also enrolled but only underwent a single phenotyping assessment and biosample collection at baseline identical to that of participants with UCPPS.


The MAPP research network: design, patient characterization and operations.

Landis JR, Williams DA, Lucia MS, Clauw DJ, Naliboff BD, Robinson NA, van Bokhoven A, Sutcliffe S, Schaeffer AJ, Rodriguez LV, Mayer EA, Lai HH, Krieger JN, Kreder KJ, Afari N, Andriole GL, Bradley CS, Griffith JW, Klumpp DJ, Hong BA, Lutgendorf SK, Buchwald D, Yang CC, Mackey S, Pontari MA, Hanno P, Kusek JW, Mullins C, Clemens JQ, MAPP Research Network Study Gro - BMC Urol (2014)

Sequence of Trans-MAPP Epidemiology and Phenotyping (EP) Study Screening, Phenotyping, Biospecimen Collection and Enrollment into the EP Study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4126395&req=5

Figure 4: Sequence of Trans-MAPP Epidemiology and Phenotyping (EP) Study Screening, Phenotyping, Biospecimen Collection and Enrollment into the EP Study.
Mentions: The screening and enrollment process utilized one in-clinic baseline study visit for informed consent and eligibility confirmation. This baseline visit was structured so that essential information, such as brief symptoms analogous to those used in previous UCPPS clinical studies (e.g., pain, pressure, discomfort and sex-specific symptom criteria) [57,58] and a urine sample dipstick could be acquired prior to the conduct of more intensive, invasive and time-consuming procedures (Figure 4). Persons meeting initial eligibility were then invited to complete the Trans-MAPP EP Study assessments, and were enrolled only after a negative 48-hour urine culture report. Eligible participants then underwent extensive baseline characterization using the standardized battery of urologic and non-urologic assessment instruments described previously. Biosamples, QST, and neuroimaging was also collected concurrently with the self-report information at baseline. Healthy controls, as well as “positive” controls (i.e., individuals with one or more non-urologic associated syndromes of primary interest; Table 2), were also enrolled but only underwent a single phenotyping assessment and biosample collection at baseline identical to that of participants with UCPPS.

Bottom Line: 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.An extended follow-up study for 161 of the UCPPS participants is ongoing.The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Urology, Division of Neurourology and Pelvic Reconstructive Surgery, University of Michigan, Ann Arbor, MI, USA. qclemens@med.umich.edu.

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.

Show MeSH
Related in: MedlinePlus