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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00672087
Other study ID # 2010P000229
Secondary ID R01DK065990
Status Completed
Phase
First received
Last updated
Start date September 2003
Est. completion date June 2011

Study information

Verified date February 2014
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Genomic and proteomic biomarker discovery
Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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