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Linkage Analysis in Interstitial Cystitis (IC)

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ClinicalTrials.gov Identifier: NCT00675298
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : February 3, 2017
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Prostatitis Cystitis, Interstitial Urinary Bladder, Overactive Chronic Pelvic Pain Syndrome Painful Bladder Syndrome

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Studies of Urologic Chronic Pelvic Pain Syndrome
Study Start Date : January 2006
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Men with chronic prostatitis/chronic pelvic pain syndrome
Women with painful bladder syndrome/interstitial cystitis
Children with overactive bladder
Bulgarian cohort with chronic prostatitis/chronic pelvic pain syndrome, painful bladder syndrome/interstitial cystitis and children with overactive bladder
Asymptomatic healthy controls

Outcome Measures

Biospecimen Retention:   Samples With DNA
Saliva and urine

Eligibility Criteria

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Self-referred patients and subjects from a Bulgarian high-prevalence CPPS population

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675298

United States, Massachusetts
Jordan D Dimitrakoff
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
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
More Information

Responsible Party: Jordan Dimitrakoff, MD, PhD, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA
ClinicalTrials.gov Identifier: NCT00675298     History of Changes
Other Study ID Numbers: 2010P000226
R01DK081647 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2014

Keywords provided by Beth Israel Deaconess Medical Center:
Cystitis, Interstitial
Urinary Bladder, Overactive
Chronic pelvic pain syndrome
Painful bladder syndrome

Additional relevant MeSH terms:
Somatoform Disorders
Pelvic Pain
Cystitis, Interstitial
Urinary Bladder, Overactive
Pathologic Processes
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Genital Diseases, Male
Lower Urinary Tract Symptoms
Urological Manifestations