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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK082316 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Colorado, Denver | OTHER |
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The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Participants with some form or symptoms of IC or CP are being asked to join the Trans-MAPP Epidemiology and Phenotyping (EP) Study.
As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP. The MAPP EP Study is an observational study that will enroll approximately 360 participants from 6 Discovery Sites and 3 Satellite Sites across the U.S. We will ask questions and gather information about the health and life of the participants for research purposes. No study treatment or interventions will be given to participants in MAPP. We hope that this study will lead to improvement in the treatment of IC and CP.
Potentially eligible participants will be scheduled for an eligibility screening session, followed by an extensive baseline phenotyping session, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit. The eligibility screening session is intended to collect the minimally sufficient data to confirm eligibility, so that the extensive baseline phenotyping session is initiated only for participants highly likely to be confirmed after the 48 hour urine culture results are known.
Participants who enroll in the study and complete a baseline clinic visit will be followed up with bi-weekly and bi-monthly internet-based questionnaires, as well as in-clinic visits at 6 and 12 months.
Participants will provide self-reported symptom data using web based internet tools on a bi-weekly basis. These questions are expected to be completed within 5-7 minutes.
A more extensive set of questionnaires will be administered to each participant every two months during the 12-month study period. The bi-monthly assessment will also be administered via the internet, and the questions are expected to be completed within 10-15 minutes.
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal outcomes for MAPP Participants | Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP EP Study. These measures can be classified into a number of primary domains as described below.
| Baseline/6 month/12 month/ bi-weekly/bi-monthly |
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Inclusion Criteria:
Participants are eligible for the Trans-MAPP EP if they meet the following:
For males or females (IC/PBS criteria)
1. Participant reports an unpleasant sensation of pain, pressure or discomfort, perceived to be related to the bladder and/or pelvic region, associated with lower urinary tract symptoms for the majority of the time during any 3 months in the previous 6 months or for the majority of the time during the most recent 3 months.
For males only (CP/CPPS criteria)
1. Male participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index for the majority of the time during any 3 months in the previous 6 months
Exclusion Criteria:
Individuals will not be eligible for enrollment in the Trans-MAPP EP Study if they meet any of the criteria listed below. Participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed, and included in the cohort study.
Exclusion Criteria for Males Only
Exclusion Criteria for Females Only
1. Female Participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.
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The Trans-MAPP EP Study population will include adult participants, at least 18 years of age, with urological chronic pelvic pain syndromes. Approximately half of the participants will be male, and half will have recent onset (within two years) of pelvic pain symptoms and/or limited treatment as determined by self-report.
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| Name | Affiliation | Role |
|---|---|---|
| J. Quentin Clemens, MD | University of Michigan | Study Chair |
| Christopher Mullins, PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35205 | United States | ||
| University of California, Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31050659 | Derived | Harte SE, Schrepf A, Gallop R, Kruger GH, Lai HHH, Sutcliffe S, Halvorson M, Ichesco E, Naliboff BD, Afari N, Harris RE, Farrar JT, Tu F, Landis JR, Clauw DJ; MAPP Research Network. Quantitative assessment of nonpelvic pressure pain sensitivity in urologic chronic pelvic pain syndrome: a MAPP Research Network study. Pain. 2019 Jun;160(6):1270-1280. doi: 10.1097/j.pain.0000000000001505. | |
| 30452963 | Derived | Rodriguez LV, Stephens AJ, Clemens JQ, Buchwald D, Yang C, Lai HH, Krieger JN, Newcomb C, Bradley CS, Naliboff B; MAPP Research Network. Symptom Duration in Patients With Urologic Chronic Pelvic Pain Syndrome is not Associated With Pain Severity, Nonurologic Syndromes and Mental Health Symptoms: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain Network Study. Urology. 2019 Feb;124:14-22. doi: 10.1016/j.urology.2018.11.015. Epub 2018 Nov 16. |
| Label | URL |
|---|---|
| MAPP Research Network Website | View source |
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DNA Blood Urine
| Los Angeles |
| California |
| 90073 |
| United States |
| Stanford University | Stanford | California | 94304 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Washington | Seattle | Washington | 98101 | United States |
| 30212850 | Derived | Schrepf A, Naliboff B, Williams DA, Stephens-Shields AJ, Landis JR, Gupta A, Mayer E, Rodriguez LV, Lai H, Luo Y, Bradley C, Kreder K, Lutgendorf SK; MAPP Research Network. Adverse Childhood Experiences and Symptoms of Urologic Chronic Pelvic Pain Syndrome: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network Study. Ann Behav Med. 2018 Sep 13;52(10):865-877. doi: 10.1093/abm/kax060. |
| 25085119 | Derived | 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 Group. The MAPP research network: design, patient characterization and operations. BMC Urol. 2014 Aug 1;14:58. doi: 10.1186/1471-2490-14-58. |
| 25085007 | Derived | Clemens JQ, Mullins C, Kusek JW, Kirkali Z, Mayer EA, Rodriguez LV, Klumpp DJ, Schaeffer AJ, Kreder KJ, Buchwald D, Andriole GL, Lucia MS, Landis JR, Clauw DJ; MAPP Research Network Study Group. 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. |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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