Genetic Studies in Interstitial Cystitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00389142
First received: October 17, 2006
Last updated: July 21, 2011
Last verified: July 2011

October 17, 2006
July 21, 2011
January 2006
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Complete list of historical versions of study NCT00389142 on ClinicalTrials.gov Archive Site
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Genetic Studies in Interstitial Cystitis
Genetic Studies in Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain Syndrome

Interstitial cystitis (also called painful bladder syndrome, or chronic pelvic pain syndrome) is a common condition with no known cure. Twin studies and family accounts have suggested that the condition may be genetic and passed down (or inherited) from one generation to the next.

In this study, we are collecting genetic material and medical information from families in North America in an attempt to identify genetic factors that may cause Interstitial Cystitis. We are enrolling families and individuals with IC/PBS/CPPS and their family members (both family members with and without IC like symptoms).

To fully describe the phenotype of interstitial cystitis (IC)/painful bladder syndrome (PBS)/chronic pelvic pain syndrome (CPPS), in adults and children, and to correlate the phenotypic information to the genotypic findings utilizing linkage analysis and candidate gene studies. A North American cohort and a Bulgarian cohort will be recruited. Both individuals and families with IC/PBS/CPPS symptoms will be recruited to give a DNA (from saliva) and urine sample.

Observational
Observational Model: Family-Based
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

We will collect and store DNA (via saliva) and urine on all participants.

Non-Probability Sample

We are collecting patients throughout North America (including the United States and Canada)

  • Interstitial Cystitis
  • Painful Bladder Syndrome
  • Chronic Pelvic Pain Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
June 2012
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Inclusion Criteria:

  • Males and females of any age
  • Urinary frequency - more than 1X/hour, and/or
  • Dysuria, and/or
  • Pelvic, suprapubic, or abdominal pain - for 3 months or longer
  • Previously normal voiding pattern ( normal retrograde voiding cystourethrogram if done)
  • Nocturia
  • Normal urinary stream (by history)
  • No evidence of active bacterial UTI (no pyuria & negative urinary culture for last 3 months)
  • First degree relative of someone with above symptoms

Exclusion Criteria:

  • Major structural/anatomical urinary tract abnormalities by ultrasound
  • Underlying inborn conditions affecting the urinary tract
  • Surgery/chemotherapy affected pelvic area
  • Severe Constipation in children only
Both
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Yes
Contact: Elicia A Estrella, MS, CGC 617-919-4552 elicia.estrella@childrens.harvard.edu
Contact: Stephanie J Brewster, MS, CGC 617-919-4551 stephanie.brewster@childrens.harvard.edu
United States
 
NCT00389142
04-11-160, PHS 398/2590
Yes
Louis M. Kunkel, Ph.D., Children's Hospital, Boston
Children's Hospital Boston
National Institutes of Health (NIH)
Principal Investigator: Louis M Kunkel, Ph.D. Children's Hosptial, Boston
Children's Hospital Boston
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP