Relationship: Interstitial Cystitis & Vulvodynia-Part 2

This study has been completed.
Sponsor:
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00751010
First received: September 10, 2008
Last updated: October 10, 2008
Last verified: October 2008
  Purpose

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
Vulvodynia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Relationship: Interstitial Cystitis & Vulvodynia-Part 2

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 127
Study Start Date: September 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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.

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.

  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 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.

Criteria

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
  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: NCT00751010

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

Responsible Party: Donna Carrico, NP, William Beaumont Hospital
ClinicalTrials.gov Identifier: NCT00751010     History of Changes
Other Study ID Numbers: 2008-139
Study First Received: September 10, 2008
Last Updated: October 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Vulvar pain
Vulvodynia
Interstitial cystitis

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

ClinicalTrials.gov processed this record on July 24, 2014