Trans-MAPP Symptom Patterns Study (SPS)
CompletedNCT02514265
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- MAPP Research Network: Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS)
- Conditions
- Sponsor
- University of Pennsylvania
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Colorado, Denver
- Start date
- 2015-07-01
- Primary completion
- 2019-03
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 6
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Patients are eligible for the SPS if they meet the following criteria: 1. 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. 2. Participant is at least 18 years of age. 3. Participant is able to speak, read, and understand English. 4. 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. 5. These symptoms have been present for the majority of the time during the most recent 3 months. 6. Participant reports a response of at least 1 on the pain, pressure or discomfort scale for UCPPS symptoms during the past 2 weeks. 7. 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. Exclusion Criteria: 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. 1. Participant has an on-going symptomatic urethral stricture. 2. Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula. 3. Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy. 4. Participant has augmentation cystoplasty or cystectomy. 5. Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV). 6. Participant has a history of cancer (with the exception of skin cancer). 7. 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.). 8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study. Exclusion Cri…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02514265