Relationship of Interstitial Cystitis to Vulvodynia

This study has been completed.
Sponsor:
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00546858
First received: October 18, 2007
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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 Intervention
Interstitial Cystitis
Other: Physical Examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Part A: STUDY OF THE RELATIONSHIP OF INTERSTITIAL CYSTITIS TO VULVODYNIA

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 350
Study Start Date: October 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Survey
Patients with interstitial cystitis
Other: Physical Examination
Patients will be invited to be evaluated in the Urology Research office at a future date.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00546858     History of Changes
Other Study ID Numbers: 2007-183
Study First Received: October 18, 2007
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014