Chronic Pelvic Pain Study of Individuals With Diagnoses or Symptoms of Interstitial Cystitis and/ or Chronic Prostatitis

Conditions

Chronic Prostatitis, Interstitial Cystitis

Keywords

Interstitial Cystitis, Chronic Prostatitis, Urological Chronic Pelvic Pain, Painful Bladder Syndrome

Brief summary

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.

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.

Javed I, Yu T, Li J, Pakpahan R, Milbrandt M, Andriole GL, Lowder JL, Lai HH, Colditz GA, Sutcliffe S.

2020-12-212 citations

10.1097/ju.0000000000001482

Adverse Childhood Experiences and Symptoms of Urologic Chronic Pelvic Pain Syndrome: A Multidisciplinary Approach to the Study of Chronic Pelvic Pain Research Network Study

Andrew Schrepf, Bruce D. Naliboff, David A. Williams, Alisa J. Stephens‐Shields, J. Richard Landis et al. (13 authors)

Annals of Behavioral Medicine2018-02-2369 citations

10.1093/abm/kax060

The MAPP research network: design, patient characterization and operations

J. Richard Landis, David A. Williams, M. Scott Lucia, Daniel J. Clauw, Bruce D. Naliboff et al. (29 authors)

BMC Urology2014-08-01148 citations

10.1186/1471-2490-14-58

The MAPP research network: a novel study of urologic chronic pelvic pain syndromes.

Clemens JQ, Mullins C, Kusek JW, Kirkali Z, Mayer EA, Rodríguez LV, Klumpp DJ, Schaeffer AJ, Kreder KJ, Buchwald D, Andriole GL, Lucia MS, Landis JR, Clauw DJ, MAPP Research Network Study Group.

2014-08-01128 citations

10.1186/1471-2490-14-57

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Longitudinal outcomes for MAPP Participants	Baseline/6 month/12 month/ bi-weekly/bi-monthly	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.

Countries

United States

Outcome results