Genetic Studies in Interstitial Cystitis - Full Text View

Sponsored by:	Children's Hospital Boston
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. It is estimated that every 15 seconds, a person in the USA is diagnosed with interstitial cystitis. Studies have suggested that the condition may be genetic and passed down (or inherited) from one generation to the next. In this study we are comparing different families' samples and medical information to determine which genetic factors may play a role in interstitial cystitis. We are enrolling families and individuals with IC/PBS/CPPS and their family members (both symptomatic and asymptomatic family members)

Condition
Interstitial Cystitis Painful Bladder Syndrome Hypersensitive Bladder Syndrome Chronic Pelvic Pain Syndrome

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

U.S. FDA Resources

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

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

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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:	January 2011

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 US cohort and a Bulgarian cohort will be recruited. Both individuals and families with IC/PBS/CPPS symptoms will be recruited to give a DNA and urine sample.

Eligibility

Ages Eligible for Study:	8 Years and older
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, probands must be age 8-adult
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
Severe Constipation

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

Investigators

Principal Investigator:

Jordan Dimitrakov, MD, PhD

Children's Hosptial, Boston

More Information

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:	Children's Hospital, Boston ( Jordan Dimitrakov, M.D., Ph.D. )
Study ID Numbers:	04-11-160, PHS 398/2590
Study First Received:	October 17, 2006
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00389142 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:

pelvic pain
urinary frequency
painful bladder

Study placed in the following topic categories:

Signs and Symptoms
Cystitis, Interstitial
Cystocele
Pelvic Pain
Urologic Diseases

Urinary Bladder Diseases
Neurologic Manifestations
Cystitis
Pain

Additional relevant MeSH terms:

Signs and Symptoms
Cystitis, Interstitial
Pathologic Processes
Disease
Pelvic Pain
Urologic Diseases

Syndrome
Nervous System Diseases
Urinary Bladder Diseases
Neurologic Manifestations
Cystitis
Pain

ClinicalTrials.gov processed this record on May 07, 2009