Diagnostic Challenges in IC (and Male CPPS)

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00672087
First received: May 2, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Bacterial Prostatitis
Asymptomatic Inflammatory Prostatitis
Painful Bladder Syndrome
Cystitis, Interstitial
Genetic: Genomic and proteomic biomarker discovery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Challenges in IC (and Male CPPS)

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 1000
Study Start Date: September 2003
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Tertiary university medical centers and primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672087

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Jordan D Dimitrakoff, MD, PhD Harvard Medical School, Boston, MA
  More Information

Publications:
Responsible Party: Jordan Dimitrakoff, MD, PhD, Director of Urogynecology and Chronic Pelvic Pain Lab, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA
ClinicalTrials.gov Identifier: NCT00672087     History of Changes
Other Study ID Numbers: DK65990, NIH DK065990
Study First Received: May 2, 2008
Last Updated: February 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
Chronic Prostatitis with Chronic Pelvic Pain Syndrome
Chronic Bacterial Prostatitis
Asymptomatic Inflammatory Prostatitis
Painful Bladder Syndrome
Cystitis, Interstitial

Additional relevant MeSH terms:
Cystitis
Pelvic Pain
Prostatitis
Syndrome
Cystitis, Interstitial
Chronic Disease
Urinary Bladder Diseases
Urologic Diseases
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on October 19, 2014