Diagnostic Challenges in IC (and Male CPPS)

Completed

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

• Registration Number: NCT00672087
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-02
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C	Genomic and proteomic biomarker discovery	Asymptomatic controls
A	Genomic and proteomic biomarker discovery	Chronic prostatitis/chronic pelvic pain syndrome patients
B	Genomic and proteomic biomarker discovery	Painful bladder syndrome/interstitial cystitis patients

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States