Diagnostic Challenges in IC (and Male CPPS)

NCT00672087 | Completed

• 2 other identifiers: 2010P000229R01DK065990
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Study Arms (3)

A

Chronic prostatitis/chronic pelvic pain syndrome patients

Genetic: Genomic and proteomic biomarker discovery

B

Painful bladder syndrome/interstitial cystitis patients

Genetic: Genomic and proteomic biomarker discovery

C

Asymptomatic controls

Genetic: Genomic and proteomic biomarker discovery

Interventions

Genomic and proteomic biomarker discovery GENETIC

Discovery of novel biomarkers for CP/CPPS and PBS/IC using genomic and proteomic methods

A; B; C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary university medical centers and primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• Major structural/anatomical urinary tract abnormalities
• Underlying inborn conditions

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

• 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. doi: 10.1001/archinte.167.18.1922.

  PMID: 17923590 BACKGROUND

• 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. doi: 10.1016/j.urology.2005.12.015. No abstract available.

  PMID: 16698346 BACKGROUND

• 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.

  PMID: 21243018 BACKGROUND

• 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.

  PMID: 20142810 BACKGROUND

• 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.

  PMID: 18308097 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Prostatitis; Cystitis, Interstitial

Interventions

Genome

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Genetic Structures; Genetic Phenomena

Study Officials

• Jordan D Dimitrakoff, MD, PhD

  Harvard Medical School, Boston, MA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: September 1, 2003
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 4, 2020

Record last verified: 2014-02

Locations

US (1)