Quantitative Studies of Urinary Bladder Sensation | NCT00903435

Studies
Quantitative Studies of Urinary Bladder Sensation

NCT00903435

Sponsor

Timothy Ness, MD

Status

Completed

Last Update Posted

Dec 1, 2011Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Interstitial Cystitis

Interventions

Quantitative Sensory Testing and Stimulus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
3R01DK051413-11S1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 23, 2009

First Submission Date that Met QC Criteria

May 15, 2009

First Posted Date

May 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2011

Last Update Posted Date

Dec 1, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Timothy Ness, MD, M.D., Ph.D., University of Alabama at BirminghamSponsor-Investigator

Lead Sponsor

Timothy Ness, MDOTHER

Collaborators

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quantitative Sensory Testing and Stimulus	Other	No therapeutic intervention will be given. Quantitative Sensory Testing, thermal/mechanical/ischemic stimulus will be performed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Ness, M.D., Ph.D.	University of Alabama at Birmingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB Kirklin Clinic		Birmingham	Alabama	35294	United States

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial
D003556	Cystitis

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided