NCT00389142

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2006Dec 2030

Study Start

First participant enrolled

January 15, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
24.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

25 years

First QC Date

October 17, 2006

Last Update Submit

December 9, 2025

Conditions

Bladder Pain SyndromeInterstitial Cystitis

Keywords

pelvic painurinary frequencypainful bladderurinary urgency

Outcome Measures

Primary Outcomes (1)

  • observational study

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

    through study completion, average of 10 years

Study Arms (1)

1 cohort

All participants will undergo genome sequencing and urinalysis studies.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators are collecting patients throughout North America (including the United States and Canada)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital (BCH)

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (2)

  • Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281. doi: 10.1016/s0090-4295(01)01138-4.

    PMID: 11489726BACKGROUND

  • Estrella E, Rockowitz S, Thorne M, Smith P, Petit J, Zehnder V, Yu RN, Bauer S, Berde C, Agrawal PB, Beggs AH, Gharavi AG, Kunkel L, Brownstein CA. Mendelian Disorders in an Interstitial Cystitis/Bladder Pain Syndrome Cohort. Adv Genet (Hoboken). 2022 Nov 27;4(1):2200013. doi: 10.1002/ggn2.202200013. eCollection 2023 Mar.

    PMID: 36910591RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The investigators will collect and store DNA (via blood or saliva) and urine samples on all participants (affected and unaffected family members). Bladder tissue if available from clinical procedure will be collected in affected participants only.

MeSH Terms

Conditions

Cystitis, InterstitialPelvic Pain

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Brownstein, Ph.D.

    Boston Children's Hosptial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elicia A Estrella, MS, LCGC

CONTACT

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

Stephanie Brewster, MS, LCGC

CONTACT

Stephanie.Brewster@childrens.harvard.edu

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Genetics and Pediatrics, Harvard Medical School

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

January 15, 2006

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

De-identified data from individual participants may be shared with other researchers. Other researchers will be approved by the internal review board at BCH.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
We will store data and samples indefinitely and may share samples/data with future collaborators.
Access Criteria
Data may be shared throughout the duration of the study. Collaborators will share de-identified data provided by study staff.

Locations

US(1)