Trans-MAPP II Study of Urologic Chronic Pelvin Pain

NCT02898220 | Completed

• 2 other identifiers: 825428U01DK082316
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Interstitial Cystitis; Chronic Prostatitis

Outcome Measures

Primary Outcomes (2)

• Pain Severity Score

  The outcome measures are the same scores which will be used to compare normal The scores for pain severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS)

  6 months

• Urinary Severity Score

  The outcome measures are the same scores which will be used to compare normal The scores for urinary severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Trans-MAPP II control study will recruit healthy controls (male and female) over a two year period.

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.
• 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.
• Participant has a positive Urine pregnancy test.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Colorado, Denver: collaborator

Study Sites (6)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Michigan, Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

Washington University, St. Louis

St Louis, Missouri, 63119, United States

Location

University of Washington, Seattle

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biologic specimens collected during the course of the study include urine, blood, saliva, and rectal and vaginal swabs.

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Richard Landis, Ph.D.

  University of Pennsylvania

  STUDY DIRECTOR

• Christopher Mullins, Ph.D

  NIDDK, NIH

  STUDY DIRECTOR

• J. Quentin Clemens, MD, MSCI

  University of Michigan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 13, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: June 1, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (6)