NCT01098279

Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis

Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Epidemiology and Phenotyping (EP) Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 424 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Interstitial Cystitis
• Chronic Prostatitis

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-06-01
• Completion: 2014-06-01
• First posted: 2010-04-02
• Last updated: 2023-08-28

Locations

8 sites across 1 country: United States