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Quantitative Studies of Urinary Bladder Sensation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903435
First Posted: May 18, 2009
Last Update Posted: December 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Timothy Ness, MD, University of Alabama at Birmingham
  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 Timothy Ness, MD, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903435


Locations
United States, Alabama
UAB Kirklin Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
Timothy Ness, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Timothy Ness, M.D., Ph.D. University of Alabama at Birmingham
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: April 23, 2009
First Posted: May 18, 2009
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by Timothy Ness, MD, University of Alabama at Birmingham:
Cystitis
Urinary
Bladder

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