NCT01138800

Brief Summary

Interstitial cystitis (IC) is a chronic disorder with significant symptoms of urinary urgency, frequency and pelvic pain. IC is more prevalent in women than men. Similar to other chronic pain syndromes such such as irritable bowel syndrome (IBS) and fibromyalgia, the cause of IC is not fully understood. Two subtypes of IC have been identified: classic IC (ulcerative IC) where visible ulcers exist in the bladder and non ulcerative IC, where bladder abnormalities are not apparent but significant bladder-related symptoms exist. We hypothesize that ulcerative IC is a disease of the bladder whereas non ulcerative IC is a more generalized and centrally-mediated chronic pain syndrome similar to IBS and fibromyalgia. To test this hypothesis, we will compare the presence of pain conditions/symptoms in ulcerative vs. non ulcerative IC women vs. community dwelling women (controls) without an IC diagnosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
666

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

June 4, 2010

Last Update Submit

February 1, 2024

Conditions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women over 18 years of age with IC identified from the investigators practice (cases); women over 18 years of age without IC (controls)

You may qualify if:

  • Women over 18 years of age with IC identified by investigator (cases);
  • Women over 18 years of age with IC (controls)

You may not qualify if:

  • Male gender;
  • subjects less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital - Urology Research

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Kenneth M Peters, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 5, 2024

Record last verified: 2024-02

Locations