Clinical trial NCT02732145: Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
Official title: Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lichen Sclerosus
Lichen Planus
Lichen Simplex Chronicus
Vulvodynia
Keywords: Three-Vulvar-Rings
Three-Rings-Vulvoscopy
N-S-P scheme
Vulvoscopy Index
Vulvar Dermatosis
Vulvar Lichen Sclerosus
Lichen Planus
Lichen Simplex Chronicus
Vulvodynia
Provoked Vestibulodynia
Vulvar Vestibulitis
Vulvar Diseases
Lead sponsor: Ginekološka Poliklinika Dr. Vesna Harni
Sponsor class: OTHER
Collaborators: name: Klinički Bolnički Centar Zagreb
name: University of Zagreb
First posted: 2016-04-08
Enrollment: 328
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We performed the same interventions: Three Rings Vulvoscopy, Vulvar Biopsy and Histopathologically Evaluation in four groups of patients with and without vulvar discomfort, with the aim to detect vulvar dermatosis.
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study was to determine sensitivity, specificity and diagnostic accuracy of "Three Rings Vulvoscopy" for detection of vulvar dermatosis using histopathology as the reference standard.

Detailed description: "Three Rings Vulvoscopy" (TRIV) is a new, and original technique for performing colposcopy of the vulva, taking into account three different skin types and zones as well as morphological evaluation of vulvar lesions according to their specificity (non-specific and lesions specific for dermatosis). To evaluate the clinical value of TRIV, we designed two index tests, a quantitative test called "Vulvoscopy Index" and a semi-quantitative test marked as "N-S-P scheme." The sensitivity, specificity and diagnostic accuracy of both index tests were estimated in comparison with histopathology as the reference test in two groups of 164 consecutive patients with vulvar discomfort (82 patients with vulvar dermatosis and 82 patients with vulvodynia ) and 164 consecutive patients without vulvar discomfort (82 patients with "normal vulva" and 82 patients with "impaired vulvar skin").

The study was performed stratified, on three levels, whereby the first two levels were pre-assignments.

The first level of the study was an evaluation of vulvar discomfort during the routine gynecological care in the clinic "Poliklinika Harni" Zagreb, Croatia, where we searched for symptomatic patients; and in the esthetic gynecological unit of the same clinic, where we searched for asymptomatic patients. Vulvar discomfort was evaluated anamnestically by the "International Society for the Study of Vulvovaginal Disease (ISSVD) Vulvodynia Pattern Questionnaire." On the second level, we performed detailed clinical examination (inspection and Cotton-Swab test), searching for non-specific and lesions specific for skin (vulvar) dermatosis, and patients with vulvodynia who fulfilled Friedrich's criteria. Patients with vulvar infection or pre/malignancy were excluded from the study. Vulvar lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia.

Among women without vulvar discomfort, we described those without any clinical findings ("normal vulva") and those with some non-specific findings on the vulva. We called this group "impaired vulvar skin." The results of the clinical examination were collected using "TRIV Form Data." On this way, we identified four groups of patients during the recruitment: vulvar dermatosis, vulvodynia, impaired vulvar skin, and normal vulva. For each patient with vulvar dermatosis (82 patients), the first consecutive patient with vulvodynia (82), impaired vulvar skin (82) and normal vulva (82) were taken for comparison.

The third level of the study presents the investigation and included diagnostic interventions "Three Rings Vulvoscopy" and vulvar biopsy with histopathology. The results of vulvoscopy were collected using "TRIV Form Data" and then assessed by "Vulvoscopy Index" and the "N-S-P Scheme." Biopsy of the vulva from the symptomatic patients was taken to confirm/exclude vulvar dermatosis. Asymptomatic patients, who were recruited from patients undergoing planned labiaplasty, granted vulvar samples to further investigation.

The statistical tests were made on a personal computer (PC) in the Statistical Package 12.0. All qualitative variables are shown in the tables with the absolute number and percentage. Quantitative variables are presented with arithmetic mean and standard deviation (if normal distribution), and by the median and range (if not a normal distribution).

A chi-squared test was used to test the difference between qualitative variables among the two groups. A chi-squared test with Yates correction was used for 2x2 size tables, and Fisher's exact test was used for small values. T-test proportions were used for the evaluation of the differences between the two percentages. Variance analysis (ANOVA) and post hoc Tukey HSD were used to test quantitative variables with normal distribution between multiple groups. Differences between the arithmetic mean of the two groups were tested by t-test.

Variables that did not have normal distribution were tested by nonparametric tests. The differences between several groups were tested by Kruskal-Wallis ANOVA and the differences between the two groups Mann-Whitney U test.

Eligibility criteria: Inclusion Criteria:

"Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December 2016.

Ability to provide Informed Consent and complete Questionnaire.

Exclusion Criteria:

Incomplete medical records. Lack of histopathology. Vulvo-vaginal infection. Benign tumors of the vulva. Pre-/malignant conditions of the vulva.

Primary outcomes:
measure: Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: Distribution of Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: "Vulvoscopy Index" (Mean ± SD) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: "Vulvoscopy Index" (Mean ± SD) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: "Vulvoscopy Index" (Median | Range) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: "Vulvoscopy Index" (Median | Range) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "N-S-P Scheme" for Detection of Vulvar Dermatosis
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
measure: Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
timeFrame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Secondary outcomes:
measure: Baseline Characteristics: Age
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Baseline Characteristics: Weight
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Baseline Characteristics: Height
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Baseline Characteristics: BMI
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Demographic Data in Patients With and Without Vulvar Discomfort
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia
timeFrame: ISSVD Questionnaire, up to 30 minutes for each participant.
measure: Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort
timeFrame: Cotton Swab Test, up to 10 minutes for each participant.
measure: Distribution of Non-Specific and Specific Vulvar Lesions in Relation to The Three Vulvar Rings (TRIV)
timeFrame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
measure: Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the "Three Rings Vulvoscopy"
timeFrame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
measure: Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the "Three Rings Vulvoscopy"
timeFrame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
measure: Distribution of Non-Specific and Specific Lesions of the Inner Vulvar Ring According to the "Three Rings Vulvoscopy"
timeFrame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
measure: Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Velocity of the Aceto-Whitening Reaction (Mean ± SD)
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Velocity of Aceto-Whitening Reaction (Median | Range)
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Middle Vulvar Ring
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Inner Vulvar Ring
timeFrame: Aceto-Whitening Test, up to 10 minutes for each participant.
measure: Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort
timeFrame: Histopathological Examination, up to 30 minutes for each vulvar sample.
measure: Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis
timeFrame: Histopathological Examination, up to 30 minutes for each vulvar sample.
measure: Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia
timeFrame: Histopathological Examination, up to 30 minutes for each vulvar sample.
measure: Histopathological Features of Vulvar Dermis in Patients With Vulvar Dermatosis Depending On The Duration of Vulvar Discomfort
timeFrame: Histopathological Examination, up to 30 minutes for each vulvar sample.
measure: Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort
timeFrame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Poliklinika Harni
Study officials:
affiliation: Poliklinika Harni, Bukovacka 1, HR-10000 Zagreb, Croatia
name: Vesna Harni, MD
role: PRINCIPAL_INVESTIGATOR
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