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Genetic Studies in Interstitial Cystitis

This study is currently recruiting participants.
Verified July 2011 by Children's Hospital Boston
Sponsor:
Collaborator:
National Institutes of Health (NIH)
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
History of Changes
  Purpose

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).


Condition
Interstitial Cystitis
Painful Bladder Syndrome
Chronic Pelvic Pain Syndrome

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Studies in Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 500
Study Start Date: January 2006
Estimated Study Completion Date: June 2012
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389142

Contacts
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

Locations
United States, Massachusetts
Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
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    
Principal Investigator: Jordan Dimitrakov, MD, PhD            
Sponsors and Collaborators
Children's Hospital Boston
National Institutes of Health (NIH)
Investigators
Principal Investigator: Louis M Kunkel, Ph.D. Children's Hosptial, Boston
  More Information

Additional Information:
This web site will take you to our Program in Genomics homepage. Click the Interstitial Cystitis button to learn about our study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Louis M. Kunkel, Ph.D., Children's Hospital, Boston
ClinicalTrials.gov Identifier: NCT00389142     History of Changes
Other Study ID Numbers: 04-11-160, PHS 398/2590
Study First Received: October 17, 2006
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
pelvic pain
urinary frequency
painful bladder
urinary urgency

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Pain
Pelvic Pain
Somatoform Disorders
Urinary Bladder Diseases
 Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013