Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/… (NCT01098279) | Clinical Trial Compass
CompletedNot Applicable
Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis
United States424 participantsStarted 2009-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant has signed and dated the appropriate Informed Consent document.
✓. Agreed to participate in Trans-MAPP EP Study procedures.
✓. Participant reports a response of at least 1 on the pain, pressure or discomfort scale.
Exclusion criteria
✕. Participant has an on-going symptomatic urethral stricture.
✕. Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
✕. Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.
✕. Participant has augmentation cystoplasty or cystectomy.
✕. Participant has a systemic autoimmune disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).
✕. Participant has a history of cancer (with the exception of skin cancer).
. Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
✕. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.