COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Relationship: Interstitial Cystitis & Vulvodynia-Part 2

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. Identifier: NCT00751010
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : October 15, 2008
Information provided by:
William Beaumont Hospitals

Brief Summary:

The etiology of pain in women with IC is often difficult to identify resulting in unnecessary medical and surgical treatments (e.g. hysterectomies). 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. Unfortunately, vulvodynia is often unrecognized since it is not part of the usual urological assessment with IC patients.

Vulvodynia is characterized by persistent generalized or localized vulvar pain of varying degrees often characterized as "burning," suggestive of a neuropathic pain response.

Condition or disease

Detailed Description:

In a mailed survey (Part 1 of this study), 127 women with a documented diagnosis of IC agreed to be contacted for an in-office examination. The mailed survey was internally developed specifically for this project and included items related to demographics, adolescent and adult history related to genital pain and current health. The last section allowed the subject to include contact information if they would also like to participate in Part 2 (additional questionnaires and examination) of the study.

The study coordinator will review those surveys containing contact information and all women at least 18 years of age will be invited to the WISH program (Beaumont Women's Initiative for Pelvic Pain and Sexual Health) to be examined by a certified Nurse Practitioner (NP) who will be blinded to their survey responses.

Questionnaires will be completed by the subject. These questionnaires relate to one's history, pain symptoms, quality of life, bladder symptoms and sexual function and will be completed prior to the examination. The NP will perform all the clinical evaluations. A vaginal pH and wet mount slide will be done first. Testing for vulvodynia will be done utilizing an algesiometer q-tip followed by Neurometer® surface CPT testing for pain threshold (not tolerance) to quantify pain levels in the distribution of the pudendal nerve on the perineum and vulva will be done. The Neurometer® current perception threshold (CPT) is a device for evaluating and measuring sensation It is a battery-operated stimulator which delivers painless electrical stimulation via surface electrodes at frequencies of 5 Hz, 250 Hz, and 2000 Hz and at a current of 0.01 to 99mAmps.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 127 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Relationship: Interstitial Cystitis & Vulvodynia-Part 2
Study Start Date : September 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

In a mailed survey (Part 1 of this study), 127 women with a documented diagnosis of IC agreed to be contacted for an in-office examination.

Primary Outcome Measures :
  1. The objective of our study is to identify and clinically confirm the presence of vulvodynia in women diagnosed with Interstitial Cystitis (IC) based on mailed survey results (Part 1, HIC #2007-183) and confirmed with a clinical assessment. [ Time Frame: Visit 1 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received a mailed survey (Part 1 of this study), with a documented diagnosis of IC who agreed to be contacted for an in-office examination.

Inclusion Criteria

  • Women with interstitial cystitis and vulvar pain who agreed to be contacted in Part 1 (HIC #2007-183) of this study.
  • Age 18 or older
  • Capable of giving informed consent
  • Capable and willing to follow all study procedures

Exclusion Criteria:

  • Pregnant women· Vaginitis (may be treated, then tested later)
  • Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia
  • The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
  • Neuropathy

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 identifier (NCT number): NCT00751010

Layout table for location information
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Layout table for investigator information
Principal Investigator: Donna Carrico, NP William Beaumont Hospitals
Layout table for additonal information
Responsible Party: Donna Carrico, NP, William Beaumont Hospital Identifier: NCT00751010    
Other Study ID Numbers: 2008-139
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: October 2008
Keywords provided by William Beaumont Hospitals:
Vulvar pain
Interstitial cystitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Vulvar Diseases