Diagnostic Challenges in IC (and Male CPPS) - Clinical Trials for Diabetes and Sexual Problems

Diagnostic Challenges in IC (and Male CPPS)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), November 2008
Sponsored by: 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

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain
U.S. FDA Resources
Study Type:Observational
Study Design:Cohort, Prospective
Official Title:Diagnostic Challenges in IC (and Male CPPS)

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

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.

Other Publications:
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
First Received:May 2, 2008
Last Updated:November 3, 2008
ClinicalTrials.gov Identifier:NCT00672087 [history]
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

Study placed in the following topic categories:
Prostatitis
Signs and Symptoms
Cystitis, Interstitial
Cystocele
Pelvic Pain
Prostatic Diseases
Urologic Diseases
Urinary Bladder Diseases
Cystitis
Chronic Disease
Pain
Genital Diseases, Male

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Disease
Syndrome