Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis (MAPP-EP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Pennsylvania
Sponsor:
Collaborators:
University of Colorado, Denver
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098279
First received: April 1, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition
Interstitial Cystitis
Chronic Prostatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidisciplinary Approach to the Study of Chronic Pelvic Pain: Trans-MAPP Epidemiology and Phenotyping (EP) Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Longitudinal outcomes for MAPP Participants [ Time Frame: Baseline/6 month/12 month/ bi-weekly/bi-monthly ] [ Designated as safety issue: No ]

    Extensive data on risk factors and outcomes measures will be collected for the Trans-MAPP EP Study. These measures can be classified into a number of primary domains as described below.

    1. Single point in time: this includes measures that do not change over time, such as demographic information, "trait measures" (e.g., personality), and early life history measures. In general, these measures are collected at the initial in-person clinic visit, although some are collected in the second (6-month) in-person visit to reduce participant burden at baseline;
    2. Baseline, 6-month and 12-month phenotyping in-clinic visits;
    3. Bi-monthly personal internet-based assessment;
    4. Bi-weekly personal internet-based assessment.


Biospecimen Retention:   Samples With DNA

DNA Blood Urine


Estimated Enrollment: 360
Study Start Date: December 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Potentially eligible participants will be scheduled for an eligibility screening session, followed by an extensive baseline phenotyping session, which together are expected to take approximately 2.5 hours to complete. Participants will be provided with breaks as needed during the clinic visit. The eligibility screening session is intended to collect the minimally sufficient data to confirm eligibility, so that the extensive baseline phenotyping session is initiated only for participants highly likely to be confirmed after the 48 hour urine culture results are known.

Participants who enroll in the study and complete a baseline clinic visit will be followed up with bi-weekly and bi-monthly internet-based questionnaires, as well as in-clinic visits at 6 and 12 months.

Participants will provide self-reported symptom data using web based internet tools on a bi-weekly basis. These questions are expected to be completed within 5-7 minutes.

A more extensive set of questionnaires will be administered to each participant every two months during the 12-month study period. The bi-monthly assessment will also be administered via the internet, and the questions are expected to be completed within 10-15 minutes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Trans-MAPP EP Study population will include adult participants, at least 18 years of age, with urological chronic pelvic pain syndromes. Approximately half of the participants will be male, and half will have recent onset (within two years) of pelvic pain symptoms and/or limited treatment as determined by self-report.

Criteria

Inclusion Criteria:

Participants are eligible for the Trans-MAPP EP if they meet the following:

  1. Participant has signed and dated the appropriate Informed Consent document.
  2. Agreed to participate in Trans-MAPP EP Study procedures.
  3. Participant reports a response of at least 1 on the pain, pressure or discomfort scale.

For males or females (IC/PBS criteria)

1. Participant reports an unpleasant sensation of pain, pressure or discomfort, perceived to be related to the bladder and/or pelvic region, associated with lower urinary tract symptoms for the majority of the time during any 3 months in the previous 6 months or for the majority of the time during the most recent 3 months.

For males only (CP/CPPS criteria)

1. Male participant reports pain or discomfort in any of the 8 domains of the Male Genitourinary Pain Index for the majority of the time during any 3 months in the previous 6 months

Exclusion Criteria:

Individuals will not be eligible for enrollment in the Trans-MAPP EP Study if they meet any of the criteria listed below. Participants who develop any of these exclusion criteria during the follow-up phase of the study will continue to be followed, and included in the cohort study.

  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 a systemic autoimmune disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, or Multiple Sclerosis).
  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 Criteria for Males Only

  1. Male Participant diagnosed with unilateral orchalgia, without pelvic symptoms.
  2. Male Participant has a history of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.

Exclusion Criteria for Females Only

1. Female Participant has a history of High-Grade Squamous Intraepithelial Lesion (HGSIL) / high-grade cervical dysplasia.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098279

Contacts
Contact: Nancy Robinson, PhD narobins@mail.med.upenn.edu
Contact: Theressa Creighton, BA theressa@mail.med.upenn.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35205
Contact: Timothy J Ness       TJNess@uab.edu   
Principal Investigator: Timothy J Ness, MD, PhD         
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90073
Contact: Suzanne Smith, NP    310-206-0310    srsmith@mednet.ucla.edu   
Principal Investigator: Emeran A Mayer, MD         
Principal Investigator: Larissa Rodriguez, MD         
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Rachel Moericke    650-723-8250    snapl@stanford.edu   
Principal Investigator: Sean Mackey, MD, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Darlene Marko, RN, BSN, CCRC    312-695-3898    d-marko@northwestern.edu   
Principal Investigator: Anthony J Schaeffer, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Mary Eno, RN    319-384-9265      
Principal Investigator: Karl J Kreder, MD, MBA         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Megan Halvorson    734-998-6839    meganeb@med.umich.edu   
Contact: Kathy Scott, RN    734-998-7105    jrsj@umich.edu   
Principal Investigator: Daniel J Clauw, MD         
United States, Missouri
Washington University Recruiting
St Louis, Missouri, United States, 63110
Contact: Viven Gardner, RN, BSN    314-996-8285    gardnerv@wudosis.wustl.edu   
Principal Investigator: Gerald Adriole, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98101
Contact: Annemarie Succop    206-543-9731    succop@u.washington.edu   
Contact: Susan Ross, RN, MN    206-543-3898    soross@u.washington.edu   
Principal Investigator: Dedra Buchwald, MD         
Sponsors and Collaborators
University of Pennsylvania
University of Colorado, Denver
Investigators
Study Chair: J. Quentin Clemens, MD University of Michigan
Study Director: Christopher Mullens, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098279     History of Changes
Other Study ID Numbers: 810643, U01DK082316
Study First Received: April 1, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
Interstitial Cystitis
Chronic Prostatitis
Urological Chronic Pelvic Pain
Painful Bladder Syndrome

Additional relevant MeSH terms:
Cystitis
Pelvic Pain
Prostatitis
Chronic Disease
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014