Diagnostic Challenges in IC (and Male CPPS) - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00672087

Purpose

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	Intervention
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 Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Diagnostic Challenges in IC (and Male CPPS)

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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

Estimated Enrollment:	1000
Study Start Date:	September 2003
Estimated Study Completion Date:	September 2023
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672087

Contacts

Contact: Jordan D Dimitrakov, MD, PhD

617-919-2521

jordan.dimitrakov@childrens.harvard.edu

Locations

United States, Massachusetts
Children's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jordan D Dimitrakov, MD, PhD 617-919-2521 jordan.dimitrakov@childrens.harvard.edu

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Director:

Jordan D Dimitrakov, MD, PhD

Harvard Medical School, Boston, MA

More Information

Publications:

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.

Dimitrakov J. A road map to biomarker discovery and validation in urological chronic pelvic pain syndrome. J Urol. 2008 May;179(5):1660-1. Epub 2008 Mar 17. No abstract available.

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. No abstract available.

Responsible Party:	Harvard Medical School and Children's Hospital, Boston, MA ( Jordan Dimitrakov, MD, PhD, Instructor in Surgery/Staff Scientist )
Study ID Numbers:	DK65990, NIH DK065990
Study First Received:	May 2, 2008
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00672087 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Additional relevant MeSH terms:

Cystitis, Interstitial
Cystitis
Disease Attributes
Disease
Prostatic Diseases
Urinary Bladder Diseases
Pain
Genital Diseases, Male

Prostatitis
Signs and Symptoms
Pathologic Processes
Pelvic Pain
Urologic Diseases
Syndrome
Chronic Disease

ClinicalTrials.gov processed this record on November 20, 2009