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Relationship of Interstitial Cystitis to Vulvodynia

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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

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).


Condition or disease Intervention/treatment
Interstitial Cystitis Other: Physical Examination

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA
Study Start Date : October 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Survey
Patients with interstitial cystitis
Other: Physical Examination
Patients will be invited to be evaluated in the Urology Research office at a future date.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546858


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Donna Carrico, NP William Beaumont Hospitals

ClinicalTrials.gov Identifier: NCT00546858     History of Changes
Other Study ID Numbers: 2007-183
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

Keywords provided by William Beaumont Hospitals:
Pelvic pain
Vulvar pain

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Vulvodynia
Urinary Bladder Diseases
Urologic Diseases
Vulvar Diseases
Genital Diseases, Female