Text Size

Assessing Chronic Pain Conditions in Patients (Pts) With and Without (w&wo) Interstitial Cystitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01138800
First received: June 4, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Interstitial Cystitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessing Chronic Pain Conditions in Patients With and Without Interstitial Cystitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Enrollment: 666
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Male gender;
  • subjects less than 18 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138800

Locations
United States, Michigan
William Beaumont Hospital - Urology Research
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
Investigators
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01138800     History of Changes
Other Study ID Numbers: 2010-094
Study First Received: June 4, 2010
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013