Diagnostic Challenges in IC (and Male CPPS)

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ClinicalTrials.gov Identifier: NCT00672087

Recruitment Status : Completed

First Posted : May 6, 2008

Last Update Posted : February 3, 2017

Sponsor:

Information provided by:

Beth Israel Deaconess Medical Center

Study Description

Brief Summary:

The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.

Condition or disease	Intervention/treatment
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Chronic Bacterial Prostatitis Asymptomatic Inflammatory Prostatitis Painful Bladder Syndrome Cystitis, Interstitial	Genetic: Genomic and proteomic biomarker discovery

Study Design


Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Diagnostic Challenges in IC (and Male CPPS)
Study Start Date :	September 2003
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
A Chronic prostatitis/chronic pelvic pain syndrome patients	Genetic: Genomic and proteomic biomarker discovery Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods
B Painful bladder syndrome/interstitial cystitis patients	Genetic: Genomic and proteomic biomarker discovery Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods
C Asymptomatic controls	Genetic: Genomic and proteomic biomarker discovery Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods

Outcome Measures

Biospecimen Retention: Samples With DNA

saliva, whole blood, serum, white cells, urine, prostatic fluid, prostate/bladder tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Tertiary university medical centers and primary care clinic

Criteria

Inclusion Criteria:

Participant has signed and dated the appropriate Informed Consent document.
Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.

Exclusion Criteria:

Major structural/anatomical urinary tract abnormalities
Underlying inborn conditions

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672087

Locations


United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators


Study Chair:	Jordan D Dimitrakoff, MD, PhD	Harvard Medical School, Boston, MA

More Information

Publications of Results:

Dimitrakov J, Joffe HV, Soldin SJ, Bolus R, Buffington CA, Nickel JC. Adrenocortical hormone abnormalities in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2008 Feb;71(2):261-6. doi: 10.1016/j.urology.2007.09.025.

Other Publications:

Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. Review. Erratum in: Arch Intern Med. 2007 Dec 10-22;167(22):2452.

Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. Review.

Allsop SA, Erstad DJ, Brook K, Bhai SF, Cohen JM, Dimitrakoff JD. The DABBEC phenotyping system: towards a mechanistic understanding of CP/CPPS. Nat Rev Urol. 2011 Feb;8(2):107-13. doi: 10.1038/nrurol.2010.227. Epub 2011 Jan 18. Review.

Strauss AC, Dimitrakov JD. New treatments for chronic prostatitis/chronic pelvic pain syndrome. Nat Rev Urol. 2010 Mar;7(3):127-35. doi: 10.1038/nrurol.2010.4. Epub 2010 Feb 9. Review.


Responsible Party:	Jordan Dimitrakoff, MD, PhD, Director of Urogynecology and Chronic Pelvic Pain Lab, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA
ClinicalTrials.gov Identifier:	NCT00672087 History of Changes
Other Study ID Numbers:	2010P000229 NIH DK065990
First Posted:	May 6, 2008 Key Record Dates
Last Update Posted:	February 3, 2017
Last Verified:	February 2014

Keywords provided by Beth Israel Deaconess Medical Center:


Chronic Prostatitis with Chronic Pelvic Pain Syndrome Chronic Bacterial Prostatitis Asymptomatic Inflammatory Prostatitis Painful Bladder Syndrome Cystitis, Interstitial

Additional relevant MeSH terms:


Syndrome Pelvic Pain Cystitis Prostatitis Cystitis, Interstitial Chronic Disease Disease Pathologic Processes	Pain Neurologic Manifestations Signs and Symptoms Urinary Bladder Diseases Urologic Diseases Prostatic Diseases Genital Diseases, Male Disease Attributes

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