Relationship of Interstitial Cystitis to Vulvodynia | NCT00546858

Studies
Relationship of Interstitial Cystitis to Vulvodynia

NCT00546858

Sponsor

Corewell Health East

Status

Completed

Last Update Posted

May 5, 2009Estimated

Enrollment

350Estimated

Phase

Not provided

Conditions

Interstitial Cystitis

Interventions

Physical Examination

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

Status Module

Record Verification Date

May 2009

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

Oct 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 18, 2007

First Submission Date that Met QC Criteria

Oct 18, 2007

First Posted Date

Oct 19, 2007Estimated

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

May 4, 2009

Last Update Posted Date

May 5, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is important in urologic nursing since many patients have interstitial cystitis (IC), a condition of frequency, urgency and pain affecting more than 1 million women in the United States. The vulva may actually be the site of some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and diminish one's quality of life.

The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC).

Detailed Description

Not provided

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

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survey		Patients with interstitial cystitis	Other: Physical Examination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Examination	Other	Patients will be invited to be evaluated in the Urology Research office at a future date.	Survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC).		Prospective

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females who are 18 years of age and older.
Diagnosis of interstitial cystitis

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of Interstitial Cystitis from the practices of Dr Ananias Diokno and Dr Kenneth Peters will be mailed a survey.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donna Carrico, NP	Corewell Health East	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial
D017699	Pelvic Pain
D056650	Vulvodynia

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012149	Restraint, Physical

Ancestor Terms

ID	Term
D032763	Behavior Control
D013812	Therapeutics
D007103	Immobilization
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided