Trans-MAPP II Study of Urologic Chronic Pelvin Pain

Completed

Conditions studied: Interstitial Cystitis, Chronic Prostatitis

In brief

The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Patients with IC or CP are being recruited for a new study called the "Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will recruit Control Participants to better understand the symptoms of individuals with some form of IC or CP. 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 and the investigators hope that this study will lead to improvement in the treatment of IC and CP.

Key facts

Study ID

NCT02898220

Run by

University of Pennsylvania

People needed

72

Starts

2016-09-01

Expected to finish

2022-06-01

Last updated by the study team

2022-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant has signed and dated the appropriate Informed Consent document.
• Agreed to participate in ALL required study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
• Gave permission for use of DNA for genetics studies.
• Gender recorded in Participant Registration module.
• Participant is at least 18 years of age.
• Participant is able to speak, read, and understand English.
• Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale (SYM-Q, Question #1).
• Participant reports no chronic pain in the pelvic or bladder region, and reports no chronic pain in any other body region.
• Participant reports no urological symptoms that have been evaluated, but are still present.

You may not qualify if…

• 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 an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
• 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.
• Participant has had definitive treatment for acute epididymitis, urethritis, vaginitis.
• Participant has history of unevaluated hematuria, this will require the evaluation of a study physician to determine if this has been appropriately evaluated.
• Participant has had a cystoscopy with hydrodistention or kenalog injection.
• Exclusion Criteria for Males Only:
• Diagnosis of unilateral orchalgia, without pelvic symptoms.
• History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
• A prostate biopsy or transurethral resection of the prostate (TURP) within the last three months.
• Exclusion Criteria for Females Only:
• Participant has a positive Urine pregnancy test.
• Specimen Exclusion Criteria (Males and Females):
• Participant has a positive dipsticParticipant has a positive urine culture.
• Fatigue Symptom Eligibility Criteria:
• Participant, for at least 3 months in the past year, has persistent fatigue not relieved with rest.
• Participant, for at least 3 months in the past year, has extreme fatigue following exercise or mild exertion.
• Participant, for at least 3 months in the past year, has impaired memory, concentration or attention.
• Exclusion Criteria - Urine test results:
• A clean-catch midstream urine specimen (VB2) will be obtained from all male and female participants during the initial and 6 month study visits, so that a urine dipstick analysis can be done for all participants, and a urine pregnancy test can be conducted for females of child bearing age excluding those who are post-menopausal and those with a history of hysterectomy.

Where it is running

• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
• Washington University, St. Louis — St Louis, Missouri, United States
• University of Washington, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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