Diagnostic Challenges in IC (and Male CPPS)

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.

Study Overview

• Status: Completed
• Conditions: Cystitis, Interstitial; Painful Bladder Syndrome; Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Bacterial Prostatitis; Asymptomatic Inflammatory Prostatitis
• Intervention / Treatment: Genetic: Genomic and proteomic biomarker discovery

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Tertiary university medical centers and primary care clinic

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Chair: Jordan D Dimitrakoff, MD, PhD, Harvard Medical School, Boston, MA

Publications and helpful links

General 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. doi: 10.1001/archinte.167.18.1922. 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. doi: 10.1016/j.urology.2005.12.015. No abstract available.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (ESTIMATE): May 6, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Painful Bladder Syndrome; Chronic Prostatitis with Chronic Pelvic Pain Syndrome; Chronic Bacterial Prostatitis; Asymptomatic Inflammatory Prostatitis; Cystitis, Interstitial
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Syndrome; Cystitis; Cystitis, Interstitial; Pelvic Pain; Prostatitis
• Other Study ID Numbers: 2010P000229; R01DK065990 (NIH)