Trans-MAPP Symptom Patterns Study (SPS)

Completed

Conditions studied: Interstitial Cystitis, Chronic Prostatitis

In brief

This study is the second phase of the MAPP Network and is designed to conduct a prospective, observational study of men and women with UCPPS, referred to as the Symptom Patterns Study (SPS), enriched with pre-defined subgroups, with longer follow-up, in order to further investigate clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.

Key facts

Study ID

NCT02514265

Run by

University of Pennsylvania

People needed

640

Starts

2015-07-01

Expected to finish

2020-06-01

Last updated by the study team

2020-07-09

Who can join

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

You may qualify if…

• Patients are eligible for the SPS if they meet the following criteria:
• Participant has signed and dated the appropriate Informed Consent document.
• Agreed to participate in ALL required Symptoms Patterns Study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
• Gave permission for use of DNA for genetics studies.
• Participant is at least 18 years of age.
• Participant is able to speak, read, and understand English.
• In the past 3 months participant has had a feeling of pain, pressure, or discomfort in the lower abdomen or pelvic area -- that is, the part of the body that is above the participant's legs and below the belly button.
• These symptoms have been present for the majority of the time during the most recent 3 months.
• Participant reports a response of at least 1 on the pain, pressure or discomfort scale for UCPPS symptoms during the past 2 weeks.
• Participant has received a clinical diagnosis of either or both IC/BPS or CP/CPPS (per AUA guidelines) or a clinician familiar with UCPPS criteria confirms participant meets UCPPS evaluation criteria per-protocol.

You may not qualify if…

• Any patient meeting any one of the following criteria will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the 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 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.
• 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.

Where it is running

• University of California Los Angeles/University of Southern California — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Michigan — 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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