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Relationship of Interstitial Cystitis to Vulvodynia

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.
ClinicalTrials.gov Identifier: NCT00546858
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
William Beaumont Hospitals

Tracking Information
First Submitted Date October 18, 2007
First Posted Date October 19, 2007
Last Update Posted Date May 5, 2009
Study Start Date October 2007
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2007)
The purpose of this two-part study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC). [ Time Frame: Prospective ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00546858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relationship of Interstitial Cystitis to Vulvodynia
Official Title Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Interstitial Cystitis
Intervention Other: Physical Examination
Patients will be invited to be evaluated in the Urology Research office at a future date.
Study Groups/Cohorts Survey
Patients with interstitial cystitis
Intervention: Other: Physical Examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: October 18, 2007)
350
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Females who are 18 years of age and older.
  • Diagnosis of interstitial cystitis
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00546858
Other Study ID Numbers 2007-183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor William Beaumont Hospitals
Collaborators Not Provided
Investigators
Principal Investigator: Donna Carrico, NP William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date May 2009