Genetic Studies in Interstitial Cystitis

This study is currently recruiting participants.

Verified July 2011 by Children's Hospital Boston

First Received on October 17, 2006. Last Updated on July 21, 2011 History of Changes

Sponsor:	Children's Hospital Boston
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00389142

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:

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

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

This link exits the ClinicalTrials.gov site

Publications:

Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. Review. No abstract available.

Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281.

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
Pain
Pelvic Pain
Cystitis, Interstitial
Somatoform Disorders
Urinary Bladder Diseases

Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012