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Clinical Trials/NCT00389142
NCT00389142
Recruiting
Not Applicable

Genetic Studies in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Boston Children's Hospital1 site in 1 country1,000 target enrollmentJanuary 15, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Boston Children's Hospital
Enrollment
1000
Locations
1
Primary Endpoint
observational study
Status
Recruiting
Last Updated
4 months ago

Overview

Brief Summary

Interstitial cystitis (IC), also called Bladder Pain syndrome (BPS) is a common condition with no known cause or cure. Twin studies and family accounts have suggested that the condition may be genetic or passed down (inherited) from one generation to another.

In this study, the investigators are collecting genetic material via blood or saliva and medical information from families in North America in an attempt to identify genetic factors that may cause IC/BPS. The investigators are enrolling inviduals with IC/BPS and their family members (family members with and without IC like symptoms). Travel to Boston not required.

Detailed Description

The investigators are trying to identify a genetic cause of interstitial cystitis (IC)/bladder pain syndrome (BPS). The investigators are looking to enroll individuals with a clinical diagnosis of IC/BPS and their family member. The investigators are attempting to determine if there is a connection between symptoms of IC/PBS and changes in specific genes or a pathway of connected genes. The investigators will use several genetic technologies including but not limited to; linkage analysis, genome sequencing, RNAseq and candidate gene studies to try to identify the cause of IC/BPS. Once the investigators identify the cause of IC/BPS they will be able to identify and design more effective treatments for affected individuals. The investigators are looking for families with IC/BPS symptoms to give a DNA sample (from blood/saliva), urine samples, and answer several questionnaires. Travel to Boston NOT necessary.

Registry
clinicaltrials.gov
Start Date
January 15, 2006
End Date
December 31, 2030
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Brownstein

Assistant Professor of Genetics and Pediatrics, Harvard Medical School

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of IC/BPS
  • 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
  • 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
  • GI or GU cancers
  • Severe Constipation in children only

Outcomes

Primary Outcomes

observational study

Time Frame: through study completion, average of 10 years

Outcome is candidate or causative genes for causing IC/BPS.

Study Sites (1)

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