Genetic Studies in Interstitial Cystitis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 17, 2006

Last Updated Date

May 23, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00389142 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Genetic Studies in Interstitial Cystitis

Official Title ^ICMJE

Genetic Studies in Interstitial Cystitis/Painful Bladder Syndrome/Chronic Pelvic Pain Syndrome

Brief Summary

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)

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Family-Based, Prospective

Condition ^ICMJE

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

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2011

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00389142

Responsible Party

Jordan Dimitrakov, M.D., Ph.D., Children's Hospital, Boston

Study ID Numbers ^ICMJE

04-11-160, PHS 398/2590

Study Sponsor ^ICMJE

Children's Hospital Boston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jordan Dimitrakov, MD, PhD

Children's Hosptial, Boston

Information Provided By

Children's Hospital Boston

Verification Date

May 2008

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