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Diagnostic Challenges in IC (and Male CPPS)

Diagnostic Challenges in IC (and Male CPPS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00672087
Enrollment
1000
Registered
2008-05-06
Start date
2003-09-30
Completion date
2011-06-30
Last updated
2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

GENETICGenomic and proteomic biomarker discovery

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026