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Linkage Analysis in Interstitial Cystitis (IC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00675298
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : February 3, 2017
Information provided by:

May 7, 2008
May 9, 2008
February 3, 2017
January 2006
June 2011   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00675298 on ClinicalTrials.gov Archive Site
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Linkage Analysis in Interstitial Cystitis
Genetic Studies of Urologic Chronic Pelvic Pain Syndrome
Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with extreme urinary urgency and frequency in the absence of any known cause. The etiologic mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected individuals, concordance among monozygotic twins, and our own preliminary studies indicate a strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use novel approaches to understand the basis of UCPPS, to identify candidate genes containing mutations that result in UCPPS and determine how the different encoded proteins of these genes interact with one another in a common biological pathway. Ultimately, understanding how mutations in at least five different genes yield the symptoms of UCPPS should lead to improved diagnosis and possible therapies.
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Observational Model: Family-Based
Time Perspective: Prospective
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Retention:   Samples With DNA
Saliva and urine
Probability Sample
Self-referred patients and subjects from a Bulgarian high-prevalence CPPS population
  • Prostatitis
  • Cystitis, Interstitial
  • Urinary Bladder, Overactive
  • Chronic Pelvic Pain Syndrome
  • Painful Bladder Syndrome
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  • 1
    Men with chronic prostatitis/chronic pelvic pain syndrome
  • 2
    Women with painful bladder syndrome/interstitial cystitis
  • 3
    Children with overactive bladder
  • 4
    Bulgarian cohort with chronic prostatitis/chronic pelvic pain syndrome, painful bladder syndrome/interstitial cystitis and children with overactive bladder
  • 5
    Asymptomatic healthy controls

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have symptoms for at least 3 months within the preceding 6 months:
  • Pain in the pelvic area
  • Urinary frequency and/or
  • Urinary urgency and/or
  • Sexual dysfunction (erectile dysfunction)
  • Have CP/CPPS, IC, PBS, or BFS
  • Be willing to provide a saliva and urine sample
  • Agree to complete several brief questionnaires
  • Family of someone with CP/CPPS, PBS, IC or BFS
  • Live in the USA or Canada

Exclusion Criteria:

  • Major structural/anatomical urinary tract abnormalities
  • Underlying inborn or congenital conditions
Sexes Eligible for Study: All
3 Years to 80 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01DK081647 ( U.S. NIH Grant/Contract )
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Jordan Dimitrakoff, MD, PhD, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: Jordan D Dimitrakoff, MD, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
February 2014