Quantitative Studies of Urinary Bladder Sensation

Interstitial Cystitis Clinical Trial

Official title:

Quantitative Studies of Urinary Bladder Sensation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903435
• Other study ID #: F060505003
• Secondary ID: 3R01DK051413-11S
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: November 30, 2011
• Start date: May 2007
• Est. completion date: November 2009

Study information

• Verified date: November 2011
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Other:
• Quantitative Sensory Testing and Stimulus
No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.

Locations

Country	Name	City	State
United States	UAB Kirklin Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Timothy Ness, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		One and a half to two hours	No