Recruiting

Genetic Causes

Sponsor:

Boston Children's Hospital

Code:

NCT00389142

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Study ID

NCT00389142

Start date

Jan 15, 2006

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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
  • 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
  • GI or GU cancers
  • Severe Constipation in children only

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

1 cohort

All participants will undergo genome sequencing and urinalysis studies.

Primary outcome measure

  • observational study [ Time Frame: through study completion, average of 10 years ]

Central Contacts and Locations

Central contacts

Elicia A Estrella, MS, LCGC

617-919-4552elicia.estrella@childrens.harvard.edu

Stephanie Brewster, MS, LCGC

Stephanie.Brewster@childrens.harvard.edu

Locations

Boston Children's Hospital (BCH)

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elicia A Estrella, MS, LCGC

617-919-4552elicia.estrella@childrens.harvard.edu

Catherine Brownstein, PhD

617-355-4764catherine.brownstein@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • pelvic pain
  • urinary frequency
  • painful bladder
  • urinary urgency

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-12-16.