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OpenTrials
Completed

NCT Number: NCT00751010

Relationship: Interstitial Cystitis & Vulvodynia-Part 2

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2008
Registry last updated
Oct 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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