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Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis (DATRIV)

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ClinicalTrials.gov Identifier: NCT02732145
Recruitment Status : Completed
First Posted : April 8, 2016
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborators:
Klinički Bolnički Centar Zagreb
University of Zagreb
Information provided by (Responsible Party):
Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni

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.

Condition or disease Intervention/treatment Phase
Lichen Sclerosus Lichen Planus Lichen Simplex Chronicus Vulvodynia Diagnostic Test: "Three Rings Vulvoscopy" (TRIV) Procedure: Histopathology Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
Study Start Date : December 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Arm Intervention/treatment
Placebo Comparator: Normal vulva

The "Normal vulva" group consisted of patients without vulvar discomfort (ISSVD Questionnaire), and without any vulvar lesion (Clinical examination) undergoing planned labioplasty. For each patient with vulvar dermatosis, the first consecutive patient with normal vulva was taken for comparison.

Interventions: Three Rings Vulvoscopy, Vulvar Biopsy, and Histopathology.

Diagnostic Test: "Three Rings Vulvoscopy" (TRIV)
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during "Three Rings Vulvoscopy" technique (TRIV Form Data). Assessing of the data by the "Vulvoscopy Index" and the "N-S-P Scheme".
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the Vulva

Placebo Comparator: Impaired vulvar skin

The group of "Impaired vulvar skin" was formed by the patients without vulvar symptoms (ISSVD Questionnaire), but with some non-specific vulvar lesions (Clinical examination) undergoing planned labioplasty, before surgery. For each patient with vulvar dermatosis, the first consecutive patient with impaired vulvar skin was taken for comparison.

Interventions: Three Rings Vulvoscopy, Vulvar Biopsy, and Histopathology.

Diagnostic Test: "Three Rings Vulvoscopy" (TRIV)
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during "Three Rings Vulvoscopy" technique (TRIV Form Data). Assessing of the data by the "Vulvoscopy Index" and the "N-S-P Scheme".
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the Vulva

Placebo Comparator: Vulvodynia

The "Vulvodynia" group consisted of patients with vulvar discomfort (ISSVD Questionnaire), who fulfilled Friedrich's criteria (Clinical examination). Non-specific lesions found with TRIV were not relevant for the diagnosis of vulvodynia. For each patient with vulvar dermatosis, the first consecutive patient with vulvodynia was taken for comparison.

Interventions: Three Rings Vulvoscopy, Vulvar Biopsy, and Histopathology.

Diagnostic Test: "Three Rings Vulvoscopy" (TRIV)
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during "Three Rings Vulvoscopy" technique (TRIV Form Data). Assessing of the data by the "Vulvoscopy Index" and the "N-S-P Scheme".
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the Vulva

Active Comparator: Vulvar dermatosis

The group of "Vulvar Dermatosis" was formed by the patients with vulvar discomfort (ISSVD Questionnaire) and vulvar lesion specific for dermatosis (Clinical examination).

Interventions: Three Rings Vulvoscopy, Vulvar Biopsy, and Histopathology.

Diagnostic Test: "Three Rings Vulvoscopy" (TRIV)
Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during "Three Rings Vulvoscopy" technique (TRIV Form Data). Assessing of the data by the "Vulvoscopy Index" and the "N-S-P Scheme".
Other Name: Colposcopy of the Vulva

Procedure: Histopathology
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Other Name: Biopsy of the Vulva




Primary Outcome Measures :
  1. Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the distribution of patients with and without vulvar dermatosis diagnosed by "Three Rings Vulvoscopy" (TRIV) using the "Vulvoscopy Index" and histopathology as a reference test.

    The Vulvoscopy Index as an outcome measure of TRIV is designed as a quantitative test based on five characteristics: vulvar complaints, Marinoff index, Cotton-Swab test, vulvar lesions according to the three vulvar rings and specificity of lesions; with following results: "Normal Vulva" (0-2 points), "Impaired Vulvar Skin" (3-11 points), "Vulvodynia" (12-18 points), and "Vulvar Dermatosis" (19-32 points).

    Since histopathology distinguishes only patients with and without vulvar dermatosis, the clinical value the Vulvoscopy Index had been estimated according to these two groups of patients. Patients with vulvoscopy diagnoses: "Normal Vulva," "Impaired Vulvar Skin" and "Vulvodynia" were classified into the group "Absent Vulvar Dermatosis."


  2. Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index" [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the distribution of patients with "Vulvar Dermatosis" diagnosed by "Three Rings Vulvoscopy" and histopathology according to single categories of the "Vulvoscopy Index."

    We described five categories within the Vulvoscopy Index:

    1. Vulvar complaints (present vs. absent),
    2. Marinoff index (positive vs. negative),
    3. Cotton-Swab test (positive vs. negative),
    4. Vulvar lesions according to the vulvar rings (Outer, Middle, and Inner Vulvar Ring Lesion) and
    5. Specificity of lesions (Non-specific and Specific Lesions).

  3. Distribution of Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index" [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the distribution of patients with "Absent Vulvar Dermatosis" diagnosed by "Three Rings Vulvoscopy" (patients with vulvoscopical diagnoses "Normal Vulva," Impaired Vulvar Skin "and" Vulvodynia") and histopathology, according to single categories of the "Vulvoscopy Index."

    The five categories within the Vulvoscopy Index are:

    1. Vulvar complaints (present vs. absent),
    2. Marinoff index (positive vs. negative),
    3. Cotton-Swab test (positive vs. negative),
    4. Vulvar lesions according to the vulvar rings (Outer, Middle, and Inner Vulvar Ring Lesion) and
    5. Specificity of lesions (Non-specific and Specific Lesions).

  4. "Vulvoscopy Index" (Mean ± SD) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the results of "Three Rings Vulvoscopy" (TRIV) by single categories of the "Vulvoscopy Index" (mean ± SD) in patients with "Vulvar Dermatosis" diagnosed by TRIV and histopathology.

    The Vulvoscopy Index is based on five characteristics:

    1. Vulvar complaints (negative=0; positive=4 points),
    2. Marinoff index (negative=0; positive=3 points),
    3. Cotton-Swab test (negative=0; positive=2 points),
    4. Vulvar lesions according to the vulvar rings (Outer Vulvar Ring Lesions=4 points; Middle Vulvar Ring Lesions=2 points and Inner Vulvar Ring Lesions=1 point) and
    5. Specificity of lesions (Non-Specific Lesions=2 points; Specific Lesions=14 points).

    According to the Vulvoscopy Index, we have set the diagnoses: "Normal Vulva" (0-2 points), "Impaired Vulvar Skin" (3-11 points), "Vulvodynia" (12-18 points), and "Vulvar Dermatosis" (19-32 points).

    The likelihood of the diagnosis of "Vulvar Dermatosis" was higher as the value of the Vulvoscopy index was higher.


  5. "Vulvoscopy Index" (Mean ± SD) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the results of "Three Rings Vulvoscopy" (TRIV) by single categories of the "Vulvoscopy Index" (mean± SD) in patients with "Absent Vulvar Dermatosis" diagnosed by TRIV and histopathology.

    According to the Vulvoscopy Index, we have set the diagnoses: "Normal Vulva" (0-2 points), "Impaired Vulvar Skin" (3-11 points), "Vulvodynia" (12-18 points), and "Vulvar Dermatosis" (19-32 points).

    Since histopathology can distinguish only patients with and without vulvar dermatosis, the distribution was estimated according to these two groups of patients. Hence, patients with vulvoscopical diagnoses "Normal Vulva," Impaired Vulvar Skin "and" Vulvodynia" were classified into the one group called "Absent Vulvar Dermatosis." The likelihood of the diagnosis of "Absent Vulvar Dermatosis" was higher as the value of the Vulvoscopy index was lower.


  6. "Vulvoscopy Index" (Median | Range) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the results of "Three Rings Vulvoscopy" (TRIV) by single categories of the "Vulvoscopy Index" (median ± SD) in patients with "Vulvar Dermatosis" diagnosed by TRIV and histopathology.

    The Vulvoscopy Index is based on five characteristics:

    1. Vulvar complaints (negative=0; positive=4 points),
    2. Marinoff index (negative=0; positive=3 points),
    3. Cotton-Swab test (negative=0; positive=2 points),
    4. Vulvar lesions according to the vulvar rings (Outer Vulvar Ring Lesions=4 points; Middle Vulvar Ring Lesions=2 points and Inner Vulvar Ring Lesions=1 point) and
    5. Specificity of lesions (Non-specific Lesions=2 points; Specific Lesions=14 points).

    According to the Vulvoscopy Index, we have set the diagnoses: "Normal Vulva" (0-2 points), "Impaired Vulvar Skin" (3-11 points), "Vulvodynia" (12-18 points), and "Vulvar Dermatosis" (19-32 points).

    The likelihood of the diagnosis of "Vulvar Dermatosis" was higher as the value of the Vulvoscopy index was higher.


  7. "Vulvoscopy Index" (Median | Range) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the results of "Three Rings Vulvoscopy" (TRIV) by single categories of the "Vulvoscopy Index" (median ± SD) in patients with "Absent Vulvar Dermatosis" diagnosed by TRIV (patients with vulvoscopical diagnoses "Normal Vulva," Impaired Vulvar Skin "and" Vulvodynia") and histopathology.

    According to the Vulvoscopy Index, we have set the diagnoses: "Normal Vulva" (0-2 points), "Impaired Vulvar Skin" (3-11 points), "Vulvodynia" (12-18 points), and "Vulvar Dermatosis" (19-32 points).

    The likelihood of the diagnosis of "Absent Vulvar Dermatosis" was higher as the value of the Vulvoscopy index was lower.


  8. Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "N-S-P Scheme" for Detection of Vulvar Dermatosis [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The distribution of patients with and without vulvar dermatosis diagnosed by vulvoscopy ("N-S-P Scheme") and histopathology.

    According to the specificity of lesions, vulvoscopy results were classified as normal "N" (absence of any lesion), suspect "S" (non-specific lesions) and pathologic "P" results (lesion specific to dermatosis); and each of the three vulvar rings is represented by a single result.

    The final vulvoscopy result is presented in the form of a three-letter formula, where the first letter indicates the vulvoscopy result in the Outer Vulvar Ring, the mean initial indicates the vulvoscopy result of the Middle Vulvar Ring and the last letter denotes the vulvoscopy result of the Inner Vulvar Ring.

    "N-S-P Scheme" divides the results of the vulvoscopy into three groups: "Normal Vulvoscopy," "Suspect Vulvoscopy" and "Pathological Vulvoscopy." Diagnosis of vulvar dermatosis was established if one or more vulvar rings showed pathological results ("Pathological Vulvoscopy").


  9. Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the distribution of vulvoscopy lesions in relation to the vulvar rings and their specificity according to the "N-S-P Scheme," in patients with vulvar dermatosis diagnosed by vulvoscopy (TRIV) and histopathology.

    Vulvoscopy findings of each of the three vulvar rings: Outer (first letter in the formula), Middle (second letter), and Inner Vulvar Ring (third letter) were evaluated as normal "N" (absence of any lesions), suspect "S" (non-specific lesions), or pathological "P" (lesions specific for dermatosis).

    "Normal vulvoscopy" indicated the absence of any lesion in all three vulvar rings ("N-N-N").

    "Suspect vulvoscopy" was used to mark findings of non-specific lesions ("S-#*-#"; "S-S-#"; "S-S-S"; "S-N-S" etc.).

    "Pathological vulvoscopy" spelled out the finding of lesions specific for dermatosis in any of the three vulvar rings ("P-#-#"; "P-P-"; "P-P-P"; "P-N-S" etc.).

    • is the label for any of the three possibilities: N or S or P.

  10. Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology [ Time Frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant. ]

    The table shows the distribution of lesions according to their specificity and vulvar rings in patients without vulvar dermatosis diagnosed by vulvoscopy (TRIV) and histopathology, as a reference test.

    According to the "N-S-P scheme," we have set the diagnoses: "Normal result" (no lesion), "Suspect result" (non-specific lesion in any of the vulvar rings), and "Pathological result" (specific for dermatosis in any of the vulvar rings).

    Since histopathology can distinguish only patients with and without dermatosis, the distribution was estimated according to these two groups of patients. Hence, patients with normal and suspect vulvoscopic results were classified into one group called "Absent Vulvar Dermatosis."



Secondary Outcome Measures :
  1. Baseline Characteristics: Age [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the age in four groups of patients with and without vulvar discomfort.

  2. Baseline Characteristics: Weight [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the weight in four groups of patients with and without vulvar discomfort.

  3. Baseline Characteristics: Height [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the height in four groups of patients with and without vulvar discomfort.

  4. Baseline Characteristics: BMI [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the body mass index (Mean ± SD) in four groups of patients with and without vulvar discomfort.

  5. Demographic Data in Patients With and Without Vulvar Discomfort [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows demographic data - age: more or less than 65 years, reproductive age, menopause, domicile country as a country of birth, the degree of education (more and less than 12 years), marital status, births, abortions, and using of contraception among four groups of patient.

  6. Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]

    The table shows various characteristics of vulvar pain (complaints) in patients with vulvar dermatosis or vulvodynia.

    Generally, we can differentiate between two categories of pain - the dull pain vs. the sharp pain depending on the nerve fibers in the skin, which are involved in the provocation of the pain.

    The symptoms of the dull pain are burning, stinging, soreness, irritation, itching, feeling of inflammation and aching.

    The symptoms of the sharp pain are a knife-like pain, paper-cuts pain, stabbing and sticking. We do not know, are there some symptoms characteristic for vulvar dermatosis or vulvodynia.


  7. Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows sexual activity and sexual abstinence due to dyspareunia or lack of a sexual partner in four groups of patients.

  8. Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]

    The table shows the degree of dyspareunia in sexually active patients with and without vulvar discomfort. We used Marinoff Index as a measure of the degree of dyspareunia.

    Negative Marinoff Index (0) is a sign of the absence of dyspareunia.

    Four grades of Marionoff Index are:

    Marinoff Index 0 = no dyspareunia; Marinoff Index 1= discomfort/pain with intercourse that doesn't interfere with the frequency of sex; Marinoff Index 2= pain with intercourse which sometimes prevents intercourse and Marinoff Index 3= pain with intercourse preventing any intercourse.


  9. Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The relationship between sexual vulvar discomfort and sexual intercourse (provocation and aggravation) in patients with vulvar dermatosis and vulvodynia, as recommended in the ISSVD Questionnaire.

  10. Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the relationship among worsening of vulvar discomfort by using tampons, cycling, wearing tight clothes, menstruation, and urination in patients with vulvar dermatosis and vulvodynia.

  11. Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the incidence of the problems with urination and defecation in four groups of patients with and without vulvar discomfort.

  12. Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the incidence of the other associated symptoms and diseases in four groups of patients, as recommended in the ISSVD Questionnaire.

  13. Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia [ Time Frame: ISSVD Questionnaire, up to 30 minutes for each participant. ]
    The table shows the incidence of the previous treatment in patients with vulvar dermatosis and vulvodynia.

  14. Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort [ Time Frame: Cotton Swab Test, up to 10 minutes for each participant. ]

    The table shows the results of Cotton-Swab Test in four groups of patients. Cotton-Swab Test or Q-Tip Testing is part of a multidisciplinary approach to the assessment of sexual pain, especially, vulvodynia or vestibulodynia, in women. ISSVD recommended the Cotton-Swab test for the differential diagnosis of vulvodynia.

    The test consists of using a cotton-swab to palpate multiple vulvar and vestibular site while recording the woman's pain.

    We performed Cotton-Swab Test by touching the vulva at 6 points (each vulvar ring), organized into locations based on a clock face and marked like the hours on the clock: 2h, 4h, 6h, 8h, 10h, and 12 h.


  15. Distribution of Non-Specific and Specific Vulvar Lesions in Relation to The Three Vulvar Rings (TRIV) [ Time Frame: Three Rings Vulvoscopy, up to 45 minutes for each participant. ]

    The table shows the distribution of non-specific and specific vulvar lesions in relation to the three vulvar rings (TRIV).

    The "OUTER Vulvar Ring" includes vulvar skin, the "MIDDLE Vulvar Ring" encompasses the modified mucosa, and the "INNER Vulvar Ring" is presented with glicogenized mucosa.

    "Non-Specific Lesions" include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.

    "Specific Lesions" comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques.


  16. Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the "Three Rings Vulvoscopy" [ Time Frame: Three Rings Vulvoscopy, up to 45 minutes for each participant. ]

    The table shows the distribution of the non-specific and specific lesions of the vulva according to individual structures of the Outer Vulvar Ring according to the TRIV.

    The "OUTER Vulvar Ring" includes vulvar skin with the following structures: mons pubis, labia majora, and the perineum.

    "Non-Specific Lesions" include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.

    "Specific Lesions" (lesions specific for vulvar dermatosis) comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques.


  17. Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the "Three Rings Vulvoscopy" [ Time Frame: Three Rings Vulvoscopy, up to 45 minutes for each participant. ]

    The table shows the distribution of non-specific and specific lesions of the vulva in relation to the individual structures of the Middle vulvar ring according to the "Three Rings Vulvoscopy." The "MIDDLE vulvar ring" includes the anterior commissure with the prepuce of the clitoris, interlabial sulci, labia minora, and the posterior commissure.

    "Non-Specific Lesions" include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.

    "Specific Lesions" comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques.


  18. Distribution of Non-Specific and Specific Lesions of the Inner Vulvar Ring According to the "Three Rings Vulvoscopy" [ Time Frame: Three Rings Vulvoscopy, up to 45 minutes for each participant. ]

    The table shows the distribution of non-specific and specific lesions of the vulva in relation to the individual structures of the Inner vulvar ring according to the "Three Rings Vulvoscopy." The "INNER vulvar ring" includes clitoris, Hart's line, urethral sulcus, urethral meatus, hymenal remnants, Bartholin's gland opening, and the vestibule.

    "Non-Specific Lesions" include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.

    "Specific Lesions" comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques.


  19. Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The table shows the presence, the quality, and the distribution of the aceto-whitening reaction after 5% acetic acid application (Aceto-Whitening Test), in relation to the three vulvar rings.

    The "OUTER Vulvar Ring" includes vulvar skin, the "MIDDLE Vulvar Ring" encompasses the modified mucosa, and the "INNER Vulvar Ring" is presented with glicogenized mucosa.

    Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.

    Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.

    The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients.


  20. Velocity of the Aceto-Whitening Reaction (Mean ± SD) [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The table shows the velocity (Mean ± SD) of the aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in patients with positive AWR classified into four groups based on anamnestic data and clinical examination.

    Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.

    Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to their higher concentration of abnormal nuclear protein and the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.

    The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein like immature squamous metaplasia, regeneration, inflammation, HPV-infection, hyperkeratosis, etc. The acetowhite reaction varies in intensity, within and between patients.


  21. Velocity of Aceto-Whitening Reaction (Median | Range) [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The table shows the velocity (Median | Range) of the aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in patients with positive AWR classified into four groups based on anamnestic data and clinical examination.

    Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.

    Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to their higher concentration of abnormal nuclear protein and the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.

    The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein like immature squamous metaplasia, regeneration, inflammation, HPV-infection, hyperkeratosis, etc. The acetowhite reaction varies in intensity, within and between patients.


  22. Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The table shows the distribution of aceto-whitening occurrence (AWR) after 5% acetic acid application in relation to the structures of the Outer Vulvar Ring.

    The "OUTER Vulvar Ring" is presented with the following structures: Mons Pubis, Labia Majora, and the Perineum.

    Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.

    Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.

    The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients.


  23. Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Middle Vulvar Ring [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The distribution of aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in relation to the structures of the Middle Vulvar Ring.

    The "MIDDLE vulvar ring" encompasses the following structures: the anterior commissure with the prepuce of the clitoris, interlabial sulci, labia minora, and the posterior commissure.


  24. Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Inner Vulvar Ring [ Time Frame: Aceto-Whitening Test, up to 10 minutes for each participant. ]

    The table shows the distribution of aceto-whitening reaction (AWR) after 5% acetic acid application (AWR - aceto-whitening reaction) in relation to the structures of the Inner Vulvar Ring.

    The "INNER Vulvar Ring" is presented with the following structures: the clitoris, Hart's line, the urethral sulcus, the urethral meatus, hymenal remnants, Bartholin's gland opening, and the vestibule.

    Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.

    Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.

    The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients.


  25. Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort [ Time Frame: Histopathological Examination, up to 30 minutes for each vulvar sample. ]
    The table shows the distribution of histopathological findings of vulvar epidermis among patients with and without vulvar discomfort, classified into four groups based on anamnestic data, clinical examination and "Three Rings Vulvoscopy." Histopathological characteristics of vulvar epidermis included hyperkeratosis, parakeratosis, acanthosis, and epidermal atrophy. In the vulvar dermis, there were evaluated presence of inflammatory infiltrates (monocytes, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers.

  26. Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis [ Time Frame: Histopathological Examination, up to 30 minutes for each vulvar sample. ]

    The table shows the relationship between histopathological features of the vulvar epidermis (normal versus abnormal) and single vulvar symptoms from the categories of the dull ("slow") and sharp ("fast") pain of the vulva in 82 patients with vulvar dermatosis.

    The dull pain comprises sensations of burning, stinging, soreness, irritation,itching, inflammation and aching.

    The fast pain includes sensations like sticking and stabbing, paper-cut or knife-like pain.


  27. Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia [ Time Frame: Histopathological Examination, up to 30 minutes for each vulvar sample. ]

    The table shows the relationship between histopathological features of the vulvar epidermis (normal versus abnormal), and single vulvar symptoms from the categories of the dull ("slow") and sharp ("fast") pain of the vulva in 82 patients with vulvodynia diagnosed anamnestically and clinically following Friedrich's criteria.

    The "dull" pain comprises sensations of burning, stinging, soreness, irritation, itching, inflammation and aching. The "fast" pain includes sensations like sticking and stabbing, paper-cut or knife-like pain.


  28. Histopathological Features of Vulvar Dermis in Patients With Vulvar Dermatosis Depending On The Duration of Vulvar Discomfort [ Time Frame: Histopathological Examination, up to 30 minutes for each vulvar sample. ]

    The table shows the relationship between histopathological features of the vulvar dermis depending on the duration of vulvar discomfort (less or more than 24 months) in 82 consecutive patients with vulvar dermatosis.

    Histopathological characteristics of vulvar dermis included inflammatory infiltrates (mononuclear, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers.


  29. Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort [ Time Frame: Histopathological Examination, up to 30 minutes for each vulvar sample. ]

    The table shows the relationship between histopathological features of the vulvar dermis depending on the duration of vulvar discomfort (less or more than 24 months) in 82 patients with vulvodynia, diagnosed anamnestically and clinically following Friedrich's criteria.

    Histopathological characteristics of vulvar dermis included inflammatory infiltrates (mononuclear, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers.




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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.


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 ClinicalTrials.gov identifier (NCT number): NCT02732145


Locations
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Croatia
Poliklinika Harni
Zagreb, Croatia, HR-10000
Sponsors and Collaborators
Ginekološka Poliklinika Dr. Vesna Harni
Klinički Bolnički Centar Zagreb
University of Zagreb
Investigators
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Principal Investigator: Vesna Harni, MD Poliklinika Harni, Bukovacka 1, HR-10000 Zagreb, Croatia

Study Data/Documents: Observational study  This link exits the ClinicalTrials.gov site
Harni V, Babic D, Barisic D. "Three Rings Vulvoscopy" - A New Approach to the Vulva. Gynaecol Perinatol 2015; 24 (1):37-45
Chapter/Commentary  This link exits the ClinicalTrials.gov site
Identifier: ISBN:978-1-63484-507-6
Harni V, Babic D, Barisic D. "Three Rings Vulvoscopy" - A New Approach to the Vulva. In: Cryosurgery and Colposcopy: Practices, Outcomes and Potential Complications, Editor: Lillian Watson. Publisher: Nova Science Publishers Inc, NewYork, USA, 2016.

Publications:

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Responsible Party: Vesna Harni, Dr. med. Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni
ClinicalTrials.gov Identifier: NCT02732145     History of Changes
Other Study ID Numbers: PH20111201001
First Posted: April 8, 2016    Key Record Dates
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vesna Harni, Ginekološka Poliklinika Dr. Vesna Harni:
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
Additional relevant MeSH terms:
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Vulvodynia
Lichen Planus
Skin Diseases
Lichen Sclerosus et Atrophicus
Neurodermatitis
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Vulvar Diseases
Genital Diseases, Female
Dermatitis
Skin Diseases, Eczematous