Trans-MAPP Epidemiology & Phenotyping Study (EPS)

The goals of the MAPP Research Network’s first phase ( MAPP I ) central clinical study – The Trans-MAPP Epidemiology and Phenotyping Study (EPS) – were to gain a better understanding of:

1. how pain and other symptoms are felt in people with Urologic Chronic Pelvic Pain Syndrome (UCPPS) and how they affect overall health;
2. the biological and clinical contributors symptoms;
3. how UCPPS relates to other chronic overlapping pain conditions (COPCs) such as Fibromyalgia, Chronic Fatigue Syndrome, or Irritable Bowel Syndrome.

All studies were designed to better understand UCPPS pathophysiology and identify distinct symptom profiles and to inform the design of future, evidence based UCPPS clinical trials for improving clinical management of patients.

The EPS was conducted by six Discovery Sites and two Core Sites:

  • Discovery Sites:
    • Northwestern University, Chicago, IL
    • University of California, Los Angeles, Los Angeles, CA
    • University of Iowa, Iowa City, IA
    • University of Michigan, Ann Arbor, MI
    • University of Washington/Washington State University, Seattle, WA
    • Washington University, St. Louis, St. Louis, MO
  • Core Sites:
    • Data Coordinating Core (DCC): University of Pennsylvania, Philadelphia, PA
    • Tissue Analysis and Technology Core (TATC): University of Colorado in Denver, Denver, CO
  • Additional Core Support Provided by:
    • The University of Southern California (USC) Laboratory of Neuroimaging (LONI): Core support for neuroimaging efforts.
    • The University of Alabama at Birmingham, Birmingham, AL and Stanford University, Stanford, CA: Participant recruitment and characterization.
    • Harvard Medical School/Boston Children’s Hospital, Boston, MA and Queens University, Kingston Ontario, Canada: Biosamples analyses.

The MAPP Research Network’s Trans-MAPP Epidemiology and Phenotyping Study (EPS) was a prospective, observational cohort study of the 1-year treated natural history (i.e., participants continued standard care by their physician while in the study) of UCPPS. In addition to enrolling men and women with UCPPS, two additional comparison groups were enrolled: “positive” control participants with one or more chronic overlapping pain conditions (COPCs) that included fibromyalgia (FM), irritable bowel syndrome (IBS), and/or chronic fatigue syndrome (CFS); and a healthy control group (individuals without UCPPS symptoms).

From 12/14/2009 through 12/14/2012 a total of 1,039 men and women were enrolled, including persons with UCPPS (n=424); persons with other co-morbid illnesses, including fibromyalgia, irritable bowel syndrome, and/or chronic fatigue syndrome (n=200 for all conditions); and healthy controls (n=415). All study participants were extensively characterized (i.e., phenotyped) at an initial baseline in-clinic visit, and UCPPS participants were further assessed during an additional 12-month follow-up period. Some participants also participated in several additional, integrated studies at individual Network sites. See Figure 3 for the general MAPP I EPS Cohort data domains and participant assessments.

Eligibility criteria for UCPPS participants included 1) age 18 years and older, 2) clinical diagnosis of IC/BPS or CP/CPPS, 3) urologic symptoms present most of the time during any 3 of the past 6 months (CP/CPPS) or the most recent 3 months (IC/BPS), and 4) reported a non-zero score for bladder/prostate and/or pelvic region pain, pressure, or discomfort during the past 2 weeks. Additional criteria excluded those with other non-UCPPS urologic or genital conditions. Healthy controls were excluded for report of any pain in the pelvic or bladder region or for chronic pain in more than one non-urologic body region, and were age and sex matched to UCPPS participants.

Similarly, positive controls were required to be free of pain in the pelvis/bladder region and had to qualify on the CMSI as having one of the targeted COPCs.

Extensive urologic and non-urologic clinical data and biological samples/measures were collected from the MAPP I EPS cohorts during an initial in-clinic deep phenotyping visit (Figure 4 for schematic of initial baseline visit flow).

The UCPPS cohort was further deep-phenotyped in-clinic at 6 and 12 months. The 12-month longitudinal follow-up for UCPPS participants also included data collection at 25 bi-weekly web-based contacts. Expanded domains of data were collected at these web-based contacts at months 2,4,6,8, and 10 (“Bi-monthly contacts”). See Figure 5 for UCPPS phenotyping in the EPS Cohort.

As shown in Figure 6, an extensive array of measures from multiple data domains (urological, nonurological, psychosocial, quantitative sensory testing, neuroimaging and molecular phenotyping) were collected at selected study contacts/visits during the EPS cohort using specialized data instruments (abbreviations are defined). Studies using relevant animal models were also performed in MAPP I to complement clinical studies.

For Additional Information on the Design and Goals of the Trans-MAPP EPS see:

Landis JR, Williams DA, Lucia MS, The MAPP research network: design, patient characterization and operations. BMC Urol.2014 Aug 1;14:58. doi: 10.1186/1471-2490-14-58. PMID: 25085119; PMC4126395.

Clemens JQ, Mullins C, Kusek JW, The MAPP research network: a novel study of urologic chronic pelvic pain syndromes. BMC Urol. 2014 Aug 1;14:57. doi: 10.1186/1471-2490-14-57. PMID: 25085007; PMC4134515.

For a Summary of Some of the Major Findings from the Trans-MAPP EPS see:

Clemens JQ, Mullins C, Ackerman AL, Urologic chronic pelvic pain syndrome: insights from the MAPP Research Network. Nat Rev Urol. 2019 Mar;16(3):187-200. doi: 10.1038/s41585-018-0135-5. PMID: 30560936; PMCID: PMC6800057

Who participated in MAPP 1?