Clinical Trial: The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

Brief Summary: To determine the sensitivity and specificity of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.

Detailed Summary:

In order to ensure a more accurate and systematic mapping of vulvar lesions, we previously described the original technique for performing colposcopy of the vulva called "Three Rings Vulvoscopy", taking into account three different skin types and zones, as well as morphological evaluation of lesions according to their specificity (non-specific and specific lesions).

As the new colposcopy technique seemed to be promising in the differential diagnosis of vulvar discomfort, we designed two index tests, a semi-quantitative test called "N-S-P scheme" and a quantitative test named "Vulvoscopy Index".

The sensitivity and specificity of both index tests will be estimated in comparison with histopathology as the reference test in two groups of asymptomatic patients ("normal vulva" - without any colposcopy lesion and "impaired vulvar skin" - with non-specific lesion) and in two groups of symptomatic patients ("vulvodynia" and "vulvar dermatosis") at the end of the study.

Vulvar discomfort and lesions are being assessed and measured with "ISSVD Vulvodynia Pattern Questionnaire" and "TRIV Form Data".

Asymptomatic patients are being recruited from asymptomatic patients undergoing planned labiaplasty, who grant vulvar samples to further investigation. Biopsy of the vulva from the symptomatic patients is being done during the routine clinical care.


Sponsor: Ginekološka Poliklinika Dr. Vesna Harni

Current Primary Outcome: The Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis. [ Time Frame: up to five years ]

Sensitivity, specificity and accuracy of the "Three-Rings Vulvoscopy" (TRIV) for detection of vulvar dermatosis assessed with two index tests, "N-S-P scheme" and "Vulvoscopy Index" in comparison to histopathology as the "golden standard" (reference test).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Epidemiological characteristics of the patients with and without vulvar discomfort. [ Time Frame: up to five years ]
    Demographic data, characteristics of the symptoms and other conditions in patients with and without vulvar discomfort assessed with "International Society for Study of Vulvovaginal Diseases (ISSVD) Vulvodynia Pattern Questionnaire".
  • Distribution of colposcopy lesions of the vulva in patients with and without vulvar discomfort according to the three vulvar rings and their specificity. [ Time Frame: up to five years ]
    Distribution of non-specific and specific colposcopy lesions according to the three vulvar rings in patients with and without vulvar discomfort assessed with "TRIV Form Data".
  • Aceto-whitening pattern in patients with vulvodynia and vulvar dermatosis according to the three vulvar rings. [ Time Frame: up to five years ]
    Aceto-acid test, the aceto-whitening pattern according to the three vulvar rings and the reaction time in different groups, assessed with "TRIV Form Data".


Original Secondary Outcome: Same as current

Information By: Ginekološka Poliklinika Dr. Vesna Harni

Dates:
Date Received: March 15, 2016
Date Started: December 2011
Date Completion: December 2016
Last Updated: September 18, 2016
Last Verified: September 2016