Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis (MAPP-EP)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Epidemiology and Phenotyping (EP) Study|
- Longitudinal outcomes for MAPP Participants [ Time Frame: Baseline/6 month/12 month/ bi-weekly/bi-monthly ] [ Designated as safety issue: No ]
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.
- Single point in time: this includes measures that do not change over time, such as demographic information, "trait measures" (e.g., personality), and early life history measures. In general, these measures are collected at the initial in-person clinic visit, although some are collected in the second (6-month) in-person visit to reduce participant burden at baseline;
- Baseline, 6-month and 12-month phenotyping in-clinic visits;
- Bi-monthly personal internet-based assessment;
- Bi-weekly personal internet-based assessment.
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098279
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35205|
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90073|
|Stanford, California, United States, 94304|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48106|
|United States, Missouri|
|St Louis, Missouri, United States, 63110|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98101|
|Study Chair:||J. Quentin Clemens, MD||University of Michigan|
|Study Director:||Christopher Mullens, PhD||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|