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
  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:


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
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: 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
Investigators
Principal Investigator: Louis M Kunkel, Ph.D. Children's Hosptial, Boston
  More Information

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
Syndrome
Disease
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014