NCT00903435

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

2.5 years

First QC Date

April 23, 2009

Last Update Submit

November 30, 2011

Conditions

Interstitial Cystitis

Keywords

CystitisUrinaryBladder

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Quantitative Sensory Testing and StimulusOTHER

No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Over 65 years old
  • Pregnant
  • Children younger than 19
  • Significant cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cystitis, InterstitialCystitis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Timothy Ness, M.D., Ph.D.

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

April 23, 2009

First Posted

May 18, 2009

Study Start

May 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations

US(1)