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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK082316 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Colorado, Denver | OTHER |
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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.
Urological Chronic Pelvic Pain Syndromes (UCPPS) are characterized by pelvic pain with concurrent urinary symptoms. Broadly, UCPPS comprise Interstitial Cystitis/Painful Bladder SyndromeBladder Pain Syndrome (IC/BPS) in men and women, and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men. IC is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 BPS as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology."2 BPS is a clinical description of disease based on the patient's symptoms, and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to IC, although diagnostic criteria are still lacking for this entity, and the relationship between BPS and IC is not clear. After the initiation phase for the MAPP SPS Study, it became clear that many of the hypotheses being proposed required well-characterized healthy "normal" controls that lack urologic pain as well as other study related symptoms/conditions. This second phase is enriched with pre-defined subgroups and a longer follow-up period which will allow further investigation of clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for Males Only:
Exclusion Criteria for Females Only:
• Participant has a positive Urine pregnancy test.
Specimen Exclusion Criteria (Males and Females):
• Participant has a positive dipsticParticipant has a positive urine culture.
Fatigue Symptom Eligibility Criteria:
Exclusion Criteria - Urine test results:
A clean-catch midstream urine specimen (VB2) will be obtained from all male and female participants during the initial and 6 month study visits, so that a urine dipstick analysis can be done for all participants, and a urine pregnancy test can be conducted for females of child bearing age excluding those who are post-menopausal and those with a history of hysterectomy.
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The Trans-MAPP II control study will recruit healthy controls (male and female) over a two year period.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles (UCLA) | Los Angeles | California | 90095 | United States | ||
| Northwestern University |
Plans are still to be finalized
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Biologic specimens collected during the course of the study include urine, blood, saliva, and rectal and vaginal swabs.
| Chicago |
| Illinois |
| 60611 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Michigan, Ann Arbor | Ann Arbor | Michigan | 48106 | United States |
| Washington University, St. Louis | St Louis | Missouri | 63119 | United States |
| University of Washington, Seattle | Seattle | Washington | 98195 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |