Quantitative Studies of Urinary Bladder Sensation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Timothy Ness, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00903435
First received: April 23, 2009
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.


Condition Intervention
Interstitial Cystitis
Other: Quantitative Sensory Testing and Stimulus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Quantitative Studies of Urinary Bladder Sensation

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The study proposes to examine the sensations that are produced by warming the skin, poking the skin, pressure on the muscles or by applying a blood pressure cuff. [ Time Frame: One and a half to two hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Quantitative Sensory Testing and Stimulus
    No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.
Detailed Description:

To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Non-healthy subjects will be recruited from Kirklin Clinic Urology Clinic and Pain Treatment Center. Healthy subjects will be recruited via advertisements.

Criteria

Inclusion Criteria:

  • Must be able to read and speak English
  • 19 years or older
  • IC Diagnosis

Exclusion Criteria:

  • Over 65 years old
  • Pregnant
  • Children younger than 19
  • Significant cardiac disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903435

Locations
United States, Alabama
UAB Kirklin Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Timothy Ness, MD
Investigators
Principal Investigator: Timothy Ness, M.D., Ph.D. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Timothy Ness, MD, M.D., Ph.D., University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00903435     History of Changes
Other Study ID Numbers: F060505003, 3R01DK051413-11S1
Study First Received: April 23, 2009
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Cystitis
Urinary
Bladder

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

ClinicalTrials.gov processed this record on July 26, 2014