An interventional study of "Three Rings Vulvoscopy" (TRIV) and Histopathology in Lichen Sclerosus, Lichen Planus and Lichen Simplex Chronicus, sponsored by Ginekološka Poliklinika Dr. Vesna Harni. Completed at 1 site in Croatia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Ginekološka Poliklinika Dr. Vesna Harni · Not applicable, Interventional, and Diagnostic
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.
"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.
30 studies on the registry are indexed under Lichen Sclerosus et Atrophicus; 8 are open to participants now.
This study's enrollment of 328 is above the median of 45 across 20 interventional studies indexed under Lichen Sclerosus et Atrophicus.
Browse Lichen Sclerosus et Atrophicus studies →This is the only study on the registry with Ginekološka Poliklinika Dr. Vesna Harni as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
"Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December 2016.
Ability to provide 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) · Procedure: Histopathology
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) · Procedure: Histopathology
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) · Procedure: Histopathology
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) · Procedure: Histopathology
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".
Also known as: Colposcopy of the Vulva
Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
Also known as: Biopsy of the Vulva
Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis
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."
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
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).
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Distribution of Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
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).
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
"Vulvoscopy Index" (Mean ± SD) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
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.
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
"Vulvoscopy Index" (Mean ± SD) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
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.
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
"Vulvoscopy Index" (Median | Range) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
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.
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
"Vulvoscopy Index" (Median | Range) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
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.
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "N-S-P Scheme" for Detection of Vulvar Dermatosis
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").
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
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.
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
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."
Time frame: ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.
Baseline Characteristics: Age
The table shows the age in four groups of patients with and without vulvar discomfort.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Baseline Characteristics: Weight
The table shows the weight in four groups of patients with and without vulvar discomfort.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Baseline Characteristics: Height
The table shows the height in four groups of patients with and without vulvar discomfort.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Baseline Characteristics: BMI
The table shows the body mass index (Mean ± SD) in four groups of patients with and without vulvar discomfort.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Demographic Data in Patients With and Without Vulvar Discomfort
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.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia
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.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort
The table shows sexual activity and sexual abstinence due to dyspareunia or lack of a sexual partner in four groups of patients.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort
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.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia
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.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia
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.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort
The table shows the incidence of the problems with urination and defecation in four groups of patients with and without vulvar discomfort.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort
The table shows the incidence of the other associated symptoms and diseases in four groups of patients, as recommended in the ISSVD Questionnaire.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia
The table shows the incidence of the previous treatment in patients with vulvar dermatosis and vulvodynia.
Time frame: ISSVD Questionnaire, up to 30 minutes for each participant.
Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort
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.
Time frame: Cotton Swab Test, up to 10 minutes for each participant.
Distribution of Non-Specific and Specific Vulvar Lesions in Relation to The Three Vulvar Rings (TRIV)
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.
Time frame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the "Three Rings Vulvoscopy"
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.
Time frame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the "Three Rings Vulvoscopy"
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.
Time frame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
Distribution of Non-Specific and Specific Lesions of the Inner Vulvar Ring According to the "Three Rings Vulvoscopy"
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.
Time frame: Three Rings Vulvoscopy, up to 45 minutes for each participant.
Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Velocity of the Aceto-Whitening Reaction (Mean ± SD)
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Velocity of Aceto-Whitening Reaction (Median | Range)
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Middle Vulvar Ring
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Inner Vulvar Ring
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.
Time frame: Aceto-Whitening Test, up to 10 minutes for each participant.
Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort
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.
Time frame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis
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.
Time frame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia
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.
Time frame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Histopathological Features of Vulvar Dermis in Patients With Vulvar Dermatosis Depending On The Duration of Vulvar Discomfort
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.
Time frame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort
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.
Time frame: Histopathological Examination, up to 30 minutes for each vulvar sample.
Patients were recruited at "Poliklinika Harni," Zagreb, Croatia, during routine gynecological care, and from esthetic unit to obtain vulvar specimens from patients with the normal vulva. For each patient with vulvar dermatosis, the first consecutive patient with vulvodynia, impaired vulvar skin, and normal vulva was taken for comparison.
| Milestone | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Started | 82 | 82 | 82 | 82 |
| Completed | 82 | 82 | 82 | 82 |
| Not completed | 0 | 0 | 0 | 0 |
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."
| Participants | Vulvoscopy: Vulvar Dermatosis | Vulvoscopy: Absent Vulvar Dermatosis |
|---|---|---|
| Histopathology: Vulvar Dermatosis | 72 | 0 |
| Histopathology: Absent Vulvar Dermatosis | 10 | 246 |
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).
| Participants | Vulvoscopy: Vulvar Dermatosis | Histopathology: Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints | 82 | 72 |
| Positive Marinoff Index | 35 | 31 |
| Positive Cotton-Swab | 28 | 24 |
| Lesions In Any Vulvar Ring | 82 | 72 |
| Outer Vulvar Ring Lesions | 77 | 68 |
| Middle Vulvar Ring Lesions | 82 | 72 |
| Inner Vulvar Ring Lesions | 74 | 68 |
| Non-Specific Lesions | 71 | 63 |
| Specific Lesions | 82 | 72 |
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).
| Participants | Vulvoscopy: Absent Vulvar Dermatosis | Histopathology: Absent Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints | 82 | 92 |
| Positive Marinoff Index | 74 | 78 |
| Positive Cotton-Swab | 104 | 108 |
| Any Vulvar Ring Lesions | 163 | 173 |
| Outer Vulvar Ring Lesions | 18 | 27 |
| Middle Vulvar Ring Lesions | 115 | 125 |
| Inner Vulvar Ring Lesions | 156 | 162 |
| Non-Specific Lesions | 163 | 171 |
| Specific Lesions | 0 | 10 |
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.
| units on a scale | Vulvoscopy: Vulvar Dermatosis | Histopathology: Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints (0-4 Points) | 4.0 ± 0.0 | 4.0 ± 0.0 |
| Marinoff Index (0-3 Points) | 1.28 ± 1.49 | 1.29 ± 1.50 |
| Cotton-Swab (0-2 Points) | 0.68 ± 0.95 | 0.67 ± 0.95 |
| Any Vulvar Ring Lesions (0-7 Points) | 6.66 ± 1.08 | 6.72 ± 1.00 |
| Outer Vulvar Ring Lesions (0-4 Points) | 3.76 ± 0.96 | 3.78 ± 0.92 |
| Middle Vulvar Ring Lesions (0-2 Points) | 2.0 ± 0.0 | 2.0 ± 0.0 |
| Inner Vulvar Ring Lesions (0-1 Point) | 0.90 ± 0.30 | 0.94 ± 0.23 |
| Specificity of Lesions (0-16) | 15.73 ± 0.69 | 15.75 ± 0.67 |
| Non-Specific Lesions (0-2 Points) | 1.73 ± 0.69 | 1.75 ± 0.67 |
| Specific Lesions (0-14 Points) | 14.0 ± 0.0 | 14.0 ± 0.0 |
| Sum (0-32 Points) | 28.35 ± 2.46 | 28.43 ± 2.47 |
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.
| units on a scale | Vulvoscopy: Absent Vulvar Dermatosis | Histopathology: Absent Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints (0-4 Points) | 1.33 ± 1.89 | 1.44 ± 1.92 |
| Marinoff Index (0-3 Points) | 0.90 ± 1.38 | 0.91 ± 1.38 |
| Cotton-Swab (0-2 Points) | 0.85 ± 0.99 | 0.84 ± 0.99 |
| Any Vulvar Ring Lesions (0-7 Points) | 1.86 ± 1.92 | 2.03 ± 2.09 |
| Outer Vulvar Ring Lesions (0-4 Points) | 0.29 ± 1.04 | 0.49 ± 1.23 |
| Middle Vulvar Ring Lesions (0-2 Points) | 0.93 ± 1.00 | 0.98 ± 1.00 |
| Inner Vulvar Ring Lesions (0-1 Point) | 0.63 ± 0.48 | 0.63 ± 0.48 |
| Specificity of Lesions (0-16 Points) | 1.33 ± 0.95 | 1.88 ± 2.93 |
| Non-Specific Lesions (0-2 Points) | 1.33 ± 0.95 | 1.34 ± 094 |
| Specific Lesions (0-14 Points) | 0.0 ± 0.0 | 0.55 ± 2.72 |
| Sum (0-32 Points) | 6.27 ± 5.89 | 7.11 ± 7.15 |
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.
| units on a scale | Vulvoscopy: Vulvar Dermatosis | Histopathology: Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints (0-4 Points) | 4 (4 to 4) | 4 (4 to 4) |
| Marinoff Index (0-3 Points) | 0 (0 to 3) | 0 (0 to 3) |
| Cotton-Swab (0-2 Points) | 0 (0 to 2) | 0 (0 to 2) |
| Any Vulvar Ring Lesions (0-7 Points) | 7 (2 to 7) | 7 (2 to 7) |
| Outer Vulvar Ring Lesions (0-4 Points) | 4 (0 to 4) | 4 (0 to 4) |
| Middle Vulvar Ring Lesions (0-2 Points) | 2 (2 to 2) | 2 (2 to 2) |
| Inner Vulvar Ring Lesions (0-1 Point) | 1 (0 to 1) | 1 (0 to 1) |
| Specificity of Lesions, in total (0-16 Points) | 16 (14 to 16) | 16 (14 to 16) |
| Non-Specific Lesions (0-2 Points) | 2 (0 to 2) | 2 (0 to 2) |
| Specific Lesions (0-14 Points) | 14 (14 to 14) | 14 (14 to 14) |
| Sum (0-32 Points) | 28.5 (21 to 32) | 28.5 (21 to 32) |
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.
| units on a scale | Vulvoscopy: Absent Vulvar Dermatosis | Histopathology: Absent Vulvar Dermatosis |
|---|---|---|
| Vulvar Complaints (0-4 Points) | 0 (0 to 4) | 0 (0 to 4) |
| Marinoff Index (0-3 Points) | 0 (0 to 3) | 0 (0 to 3) |
| Cotton-Swab (0-2 Points) | 0 (0 to 2) | 0 (0 to 2) |
| Any Vulvar Ring Lesions (0-7 Points) | 1 (0 to 7) | 1 (0 to 7) |
| Outer Vulvar Ring Lesions (0-4 Points) | 0 (0 to 4) | 0 (0 to 4) |
| Middle Vulvar Ring Lesions (0-2 Points) | 0 (0 to 2) | 0 (0 to 2) |
| Inner Vulvar Ring Lesions (0-1 Point) | 1 (0 to 1) | 1 (0 to 1) |
| Specificity of Lesions, in total (0-16 Points) | 2 (0 to 2) | 2 (0 to 16) |
| Non-Specific Lesions (0-2 Points) | 2 (0 to 2) | 2 (0 to 2) |
| Specific Lesions (0-14 Points) | 0 (0 to 0) | 0 (0 to 14) |
| Sum (0-32 Points) | 5 (0 to 18) | 5 (0 to 32) |
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").
| Participants | Vulvoscopy: Vulvar Dermatosis | Vulvoscopy: Absent Vulvar Dermatosis |
|---|---|---|
| Histopathology: Vulvar Dermatosis | 72 | 0 |
| Histopathology: Absent Vulvar Dermatosis | 10 | 246 |
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.
| Participants | Vulvoscopy: Vulvar Dermatosis | Histopathology: Vulvar Dermatosis |
|---|---|---|
| Outer Vulvar Ring: No Lesion | N-#-# | 6 | 5 |
| Outer Vulvar Ring: Non-Specific Lesions | S-#-# | 24 | 22 |
| Outer Vulvar Ring: Specific Lesions | P-#-# | 73 | 64 |
| Middle Vulvar Ring: No Lesion | #-N-# | 0 | 0 |
| Middle Vulvar Ring: Non-Specific Lesions | #-S-# | 41 | 35 |
| Middle Vulvar Ring: Specific Lesions | #-P-# | 73 | 65 |
| Inner Vulvar Ring: No Lesion | #-#-N | 9 | 5 |
| Inner Vulvar Ring: Non-Specific Lesions | #-#-S | 55 | 51 |
| Inner Vulvar Ring: Specific Lesions | #-#-P | 49 | 46 |
| All Three Vulvar Rings: No Lesion N-N-N | 0 | 0 |
| Any Vulvar Ring: Non-Specific Lesions | 67 | 60 |
| Any Vulvar Ring: Specific Lesions | 82 | 72 |
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."
| Participants | Vulvoscopy: Absent Vulvar Dermatosis | Histopathology: Absent Vulvar Dermatosis |
|---|---|---|
| Outer Vulvar Ring: No Lesion | N-#-# | 227 | 228 |
| Outer Vulvar Ring: Non-Specific Lesions | S-#-# | 18 | 20 |
| Outer Vulvar Ring: Specific Lesions | P-#-# | 0 | 9 |
| Middle Vulvar Ring: No Lesion | #-N-# | 131 | 131 |
| Middle Vulvar Ring: Non-Specific Lesions | #-S-# | 115 | 121 |
| Middle Vulvar Ring: Specific Lesions | #-P-# | 0 | 8 |
| Inner Vulvar Ring: No Lesion | #-#-N | 89 | 93 |
| Inner Vulvar Ring: Non-Specific Lesions | #-#-S | 157 | 161 |
| Inner Vulvar Ring: Specific Lesions | #-#-P | 0 | 3 |
| All Three Vulvar Rings: No Lesion N-N-N | 83 | 83 |
| Any Vulvar Ring: Non-Specific Lesions | 163 | 170 |
| Any Vulvar Ring: Specific Lesions | 0 | 10 |
The table shows the age in four groups of patients with and without vulvar discomfort.
| years | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Baseline Characteristics: Age | 34.2 ± 10.0 | 34.4 ± 9.4 | 34.2 ± 10.0 | 51.1 ± 16.2 |
The table shows the weight in four groups of patients with and without vulvar discomfort.
| kg | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Baseline Characteristics: Weight | 61.9 ± 8.3 | 63.3 ± 10.9 | 61.1 ± 9.2 | 71.3 ± 12.0 |
The table shows the height in four groups of patients with and without vulvar discomfort.
| cm | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Baseline Characteristics: Height | 169.1 ± 6.0 | 168.7 ± 6.3 | 166.7 ± 6.7 | 167.5 ± 5.7 |
The table shows the body mass index (Mean ± SD) in four groups of patients with and without vulvar discomfort.
| kg/m^2 | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Baseline Characteristics: BMI | 21.6 ± 2.5 | 22.3 ± 3.6 | 22.0 ± 2.9 | 25.4 ± 4.1 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Age: ≥ 65 years | 0 | 1 | 0 | 15 |
| Age: < 65 years | 82 | 81 | 82 | 67 |
| Reproductive Age | 77 | 79 | 76 | 36 |
| Menopausal age | 5 | 3 | 6 | 46 |
| Domicile country (Croatia) as a Country of Birth | 68 | 62 | 68 | 61 |
| Education: >12 Years | 52 | 58 | 52 | 42 |
| Education: ≤12 Years | 30 | 24 | 30 | 40 |
| Married | 44 | 39 | 44 | 69 |
| Nuliparious | 49 | 52 | 44 | 17 |
| Multiparous (3 and more births) | 6 | 4 | 6 | 12 |
| Abortion | 8 | 7 | 15 | 29 |
| Contraception | 21 | 16 | 20 | 10 |
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.
| Participants | Vulvar Dermatosis | Vulvodynia |
|---|---|---|
| Dull / Slow Pain | 82 | 81 |
| Burning | 22 | 37 |
| Stinging | 65 | 66 |
| Soreness | 37 | 54 |
| Irritation | 35 | 48 |
| Itching | 79 | 63 |
| Inflammation | 38 | 49 |
| Aching | 21 | 45 |
| Sharp / Fast Pain | 12 | 31 |
| Knife-Like Pain | 5 | 13 |
| Paper-Cuts Pain | 3 | 10 |
| Stabbing | 6 | 17 |
| Sticking | 9 | 18 |
| Association Of Symptoms | 24 | 64 |
| Duration Of Discomfort >24 month | 58 | 53 |
| Duration Of Discomfort >12 monts | 11 | 16 |
| Duration Of Discomfort >6 months | 9 | 8 |
The table shows sexual activity and sexual abstinence due to dyspareunia or lack of a sexual partner in four groups of patients.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Sexually Active Patients | 81 | 77 | 73 | 49 |
| No sexual activity | 1 | 5 | 9 | 33 |
| Sexual Abstinence Due To Dyspareunia | 1 | 1 | 8 | 1 |
| Dyspareunia And Lack Of Partner | 0 | 0 | 9 | 32 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Dyspareunia | 1 | 1 | 73 | 34 |
| Marinoff Index 0 | 80 | 76 | 0 | 0 |
| Marinoff Index 1 | 1 | 0 | 22 | 7 |
| Marinoff Index 2 | 0 | 1 | 40 | 18 |
| Marinoff Index 3 | 0 | 0 | 11 | 9 |
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.
| Participants | Vulvar Dermatosis | Vulvodynia |
|---|---|---|
| Sexually active patients | 49 | 73 |
| Intercourse aggravates vulvar discomfort | 0 | 27 |
| Penetration aggravates vulvar complaints | 16 | 39 |
| Vulvar complaints during intercourse | 15 | 21 |
| Vulvar complaints after intercourse | 14 | 42 |
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.
| Participants | Vulvar Dermatosis | Vulvodynia |
|---|---|---|
| Using of tampons | 21 | 54 |
| Tampon aggravates vulvar complaints | 7 | 21 |
| Cycling | 19 | 42 |
| Cycling aggravates vulvar complaints | 9 | 26 |
| Wearing tight clothes | 44 | 70 |
| Tight clothes aggravates vulvar complaints | 26 | 46 |
| Menstrual cycle | 36 | 76 |
| Influence of menstrual cycle on symptoms | 15 | 44 |
| Worsening before menstrual bleeding | 5 | 27 |
| Worsening during menstrual bleeding | 4 | 6 |
| Worsening after menstrual bleeding | 7 | 18 |
| Worsening between menstrual bleeding | 3 | 4 |
| Worsening during urination | 30 | 39 |
| Worsening during urination after intercourse | 7 | 14 |
The table shows the incidence of the problems with urination and defecation in four groups of patients with and without vulvar discomfort.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Any Problem With Urinating and Defecation | 54 | 47 | 74 | 72 |
| Dysuria | 7 | 7 | 36 | 33 |
| Intermittent Dysuria | 7 | 7 | 26 | 26 |
| Frequent Dysuria | 0 | 0 | 10 | 7 |
| Urinary Incontinence | 16 | 11 | 19 | 32 |
| Intermittent Urinary Incontinence | 16 | 10 | 17 | 21 |
| Frequent Urinary Incontinence | 0 | 1 | 2 | 11 |
| Difficulties At Starting Urination | 2 | 1 | 12 | 9 |
| Intermittent Diff. At Starting Urination | 2 | 0 | 11 | 7 |
| Frequent Diff. At Starting Urination | 0 | 1 | 1 | 2 |
| Urgency | 11 | 11 | 24 | 24 |
| Intermittent Urgency | 11 | 11 | 22 | 15 |
| Frequent Urgency | 0 | 0 | 2 | 9 |
| Nocturia | 30 | 22 | 40 | 56 |
| Intermittent Nocturia | 25 | 20 | 31 | 30 |
| Frequent Nocturia | 5 | 2 | 9 | 26 |
| Recurrent Cystitis | 8 | 4 | 15 | 10 |
| Constipation | 12 | 16 | 27 | 20 |
| Intermittent Constipation | 9 | 13 | 20 | 14 |
| Frequent Constipation | 3 | 3 | 7 | 6 |
| Diarrhea | 3 | 2 | 9 | 12 |
| Intermittent Diarrhea | 3 | 1 | 7 | 10 |
| Frequent Diarrhea | 0 | 1 | 2 | 2 |
| Irritable Colon | 0 | 2 | 7 | 9 |
The table shows the incidence of the other associated symptoms and diseases in four groups of patients, as recommended in the ISSVD Questionnaire.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Other Symptoms and Diseases | 52 | 58 | 79 | 75 |
| Recurrent Headache | 13 | 17 | 21 | 14 |
| Chronic Fatigue | 4 | 10 | 28 | 25 |
| Lumbar Pain | 14 | 24 | 40 | 34 |
| Fibromyalgia | 3 | 13 | 31 | 23 |
| Energy Loss | 11 | 22 | 50 | 43 |
| Sleep Disorders | 9 | 14 | 23 | 35 |
| Pelvic Pain | 2 | 7 | 28 | 17 |
| Unintended Weight Loss | 7 | 1 | 6 | 4 |
| Endometriosis | 1 | 4 | 6 | 4 |
| "D-D-D Triad" | 0 | 1 | 7 | 1 |
| Hypertension | 2 | 0 | 2 | 22 |
| Angina pectoris | 0 | 0 | 0 | 2 |
| Diabetes mellitus | 0 | 0 | 0 | 2 |
| Genital Herpes | 2 | 1 | 2 | 2 |
| Thyroid Disease | 11 | 8 | 24 | 24 |
| Drug Allergy | 9 | 8 | 15 | 8 |
| Recurrent Attacs of Sinusitis | 10 | 26 | 23 | 15 |
| HPV Testing | 29 | 36 | 45 | 19 |
| Positive Human Papillomavirus (HPV) test | 9 | 20 | 19 | 10 |
| Abnormal Papanicolaou (PAP) Smear | 8 | 19 | 25 | 10 |
| Genital Warts | 1 | 3 | 6 | 3 |
| Conization | LETZ (Loop Excis. of the Trans. Zone) | 4 | 11 | 10 | 7 |
The table shows the incidence of the previous treatment in patients with vulvar dermatosis and vulvodynia.
| Participants | Vulvar Dermatosis | Vulvodynia |
|---|---|---|
| Any prior treatment | 33 | 42 |
| Antifungals Local | 26 | 39 |
| Antifungals Systemic | 10 | 12 |
| Antibiotics Local | 18 | 22 |
| Antibiotics Systemic | 11 | 17 |
| Corticosteroids Local | 25 | 5 |
| Corticosteroids Systemic | 1 | 0 |
| Antidepressants | 1 | 5 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Positive Cotton Swab Test, generally (any point) | 10 | 11 | 73 | 28 |
| Positive Cotton Swab at the point of 2h | 2 | 4 | 34 | 9 |
| Positive Cotton Swab at the point of 4h | 6 | 9 | 58 | 17 |
| Positive Cotton Swab at the point of 6h | 7 | 11 | 62 | 21 |
| Positive Cotton Swab at the point of 8h | 6 | 11 | 59 | 18 |
| Positive Cotton Swab at the point of 10h | 4 | 9 | 42 | 11 |
| Positive Cotton Swab at the point of 12h | 3 | 8 | 38 | 9 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Non-specific Findings of the Outer Vulvar Ring | 0 | 4 | 15 | 58 |
| Non-specific Findings of the Middle Vulvar Ring | 26 | 71 | 79 | 68 |
| Non-specific Findings of the Inner Vulvar Ring | 32 | 79 | 81 | 70 |
| Erythema of the Outer Vulvar Ring | 0 | 3 | 12 | 27 |
| Erythema of the Middle Vulvar Ring | 2 | 41 | 62 | 45 |
| Erythema of the Inner Vulvar Ring | 11 | 61 | 76 | 59 |
| Excoriations of the Outer Vulvar Ring | 0 | 0 | 2 | 23 |
| Fissures of the Middle Vulvar Ring | 0 | 0 | 2 | 29 |
| Fissures of the Inner Vulvar Ring | 0 | 0 | 0 | 3 |
| Rhagades of the Outer Vulvar Ring | 0 | 1 | 0 | 32 |
| Smoothness of the Middle Vulvar Ring | 0 | 3 | 0 | 13 |
| Smoothness of the Inner Vulvar Ring | 12 | 23 | 41 | 28 |
| Ischemia of the Middle Vulvar Ring | 0 | 5 | 6 | 2 |
| Ischemia of the Inner Vulvar Ring | 6 | 36 | 40 | 27 |
| Punctuation of the Middle Vulvar Ring | 0 | 1 | 8 | 3 |
| Punctuation of the Inner Vulvar Ring | 0 | 36 | 45 | 20 |
| Papillae of the Inner Vulvar Ring | 9 | 21 | 21 | 2 |
| Specific Lesions of the Outer Vulvar Ring | 0 | 0 | 0 | 73 |
| Specific Lesions of the Middle Vulvar Ring | 0 | 0 | 0 | 66 |
| Specific Lesions of the Inner Vulvar Ring | 0 | 0 | 0 | 49 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Non-specific Lesions of Mons Pubis | 0 | 1 | 2 | 18 |
| Non-specific Lesions of Labia Majora | 0 | 1 | 7 | 38 |
| Non-specific Lesions of the Perineum | 0 | 4 | 15 | 51 |
| Erythema of Mons Pubis | 0 | 1 | 2 | 12 |
| Erythema of Labia Majora | 0 | 1 | 6 | 24 |
| Erythema of the Perineum | 0 | 3 | 11 | 20 |
| Excoriations of Mons Pubis | 0 | 0 | 0 | 9 |
| Excoriations of Labia Majora | 0 | 0 | 0 | 18 |
| Excoriations of the Perineum | 0 | 0 | 2 | 16 |
| Rhagades of Mons Pubis | 0 | 0 | 0 | 5 |
| Rhagades of Labia Majora | 0 | 0 | 0 | 12 |
| Rhagades of the Perineum | 0 | 1 | 0 | 28 |
| Specific Lesions of Mons Pubis | 0 | 0 | 0 | 30 |
| Specific Lesions of Labia Majora | 0 | 0 | 0 | 55 |
| Specific Lesions of the Perineum | 0 | 0 | 0 | 65 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Non-specific Lesions of the Anterior Commissure | 1 | 7 | 9 | 30 |
| Non-specific Lesions of Interlabial Sulci | 1 | 32 | 41 | 46 |
| Non-specific Lesions of Labia Minora | 10 | 25 | 48 | 42 |
| Non-specific Lesions of the Posterior Commissure | 23 | 56 | 76 | 56 |
| Erythema of the Anterior Commissure | 0 | 3 | 3 | 8 |
| Erythema of Interlabial Sulci | 0 | 28 | 35 | 25 |
| Erythema of Labia Minora | 10 | 9 | 25 | 21 |
| Erythema of the Posterior Commissure | 23 | 23 | 48 | 33 |
| Fissures of the Anterior Commissure | 0 | 0 | 0 | 6 |
| Fissures of Interlabial Sulci | 0 | 0 | 0 | 12 |
| Fissures of Labia Minora | 0 | 0 | 0 | 5 |
| Fissures of the Posterior Commissure | 0 | 0 | 2 | 20 |
| Smoothness of the Anterior Commissure | 0 | 0 | 0 | 9 |
| Smoothness of Interlabial Sulci | 0 | 1 | 0 | 11 |
| Smoothness of Labia Minora | 0 | 1 | 0 | 6 |
| Smoothness of the Posterior Commissure | 0 | 2 | 0 | 5 |
| Specific Lesions of the Anterior Commissure | 0 | 0 | 0 | 58 |
| Specific Lesions of Interlabial Sulci | 0 | 0 | 0 | 64 |
| Specific Lesions of Labia Minora | 0 | 0 | 0 | 60 |
| Specific Lesions of the Posterior Commissure | 0 | 0 | 0 | 61 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Non-specific Lesions of the clitoris | 8 | 43 | 76 | 34 |
| Non-specific Lesions of Hart's line | 21 | 68 | 81 | 55 |
| Non-specific Lesions of the Urethral Sulcus | 16 | 69 | 81 | 55 |
| Non-specific Lesions of the Urethral Meatus | 7 | 45 | 72 | 43 |
| Non-specific Lesions of Hymenal remnants | 6 | 37 | 69 | 30 |
| Non-specific Lesions of Bartholin's gland opening | 8 | 49 | 77 | 33 |
| Non-specific Lesions of the Vestibule | 22 | 59 | 80 | 61 |
| Erythema of the clitoris | 0 | 11 | 29 | 5 |
| Erythema of Hart's line | 11 | 52 | 69 | 43 |
| Erythema of the Urethral Sulcus | 0 | 26 | 43 | 16 |
| Erythema of the Urethral Meatus | 1 | 6 | 18 | 20 |
| Erythema of Hymenal remnants | 5 | 7 | 17 | 16 |
| Erythema of Bartholin's gland opening | 7 | 30 | 49 | 24 |
| Erythema of the Vestibule | 9 | 29 | 45 | 41 |
| Smoothness of the clitoris | 0 | 5 | 3 | 11 |
| Smootness of Hart's line | 1 | 1 | 1 | 5 |
| Smoothness of the Urethral Sulcus | 12 | 22 | 37 | 26 |
| Smoothness of the Urethral Meatus | 2 | 2 | 1 | 6 |
| Smoothness of Hymenal remnants | 1 | 1 | 0 | 5 |
| Smoothness of Bartholin's gland opening | 1 | 1 | 0 | 5 |
| Smoothness of the Vestibule | 3 | 3 | 4 | 6 |
| Ischemia of the clitoris | 0 | 11 | 14 | 8 |
| Ischemia of Hart's line | 1 | 1 | 4 | 1 |
| Ischemia of the Urethral Sulcus | 4 | 31 | 24 | 21 |
| Ischemia of the Urethral Meatus | 2 | 3 | 9 | 2 |
| Ischemia of Hymenal remnants | 0 | 0 | 4 | 2 |
| Ischemia of Bartholin's gland opening | 0 | 0 | 3 | 2 |
| Ischemia of the Vestibule | 6 | 7 | 14 | 8 |
| Punctuation of the clitoris | 0 | 0 | 0 | 0 |
| Punctuation of Hart's line | 0 | 36 | 43 | 12 |
| Punctuation of the Urethral Sulcus | 0 | 3 | 2 | 0 |
| Punctuation of the Urethral Meatus | 0 | 1 | 4 | 4 |
| Punctuation of Hymenal remnants | 0 | 2 | 5 | 3 |
| Punctuation of Bartholin's gland opening | 0 | 1 | 4 | 4 |
| Punctuation of the Vestibule | 0 | 8 | 10 | 8 |
| Papillae of Hart's line | 8 | 17 | 18 | 2 |
| Papillae of the Urethral Sulcus | 0 | 0 | 2 | 0 |
| Papillae of the Vestibule | 4 | 12 | 10 | 1 |
| Specific Lesions of the clitoris | 0 | 0 | 0 | 43 |
| Specific Lesions of Hart's line | 0 | 0 | 0 | 28 |
| Specific Lesions of the Urethral Sulcus | 0 | 0 | 0 | 36 |
| Specific Lesions of the Urethral Meatus | 0 | 0 | 0 | 29 |
| Specific Lesions of Hymenal remnants | 0 | 0 | 0 | 27 |
| Specific Lesions of Bartholin's gland opening | 0 | 0 | 0 | 25 |
| Specific Lesions of the Vestibule | 0 | 0 | 0 | 29 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Aceto-Whitening Presence | Positive AWR | 38 | 74 | 81 | 57 |
| Semitransparent AWR: Presence | 38 | 71 | 68 | 53 |
| Coarse AWR: Presence | 0 | 3 | 13 | 4 |
| Fast AWR (<30 sec) | 1 | 7 | 12 | 9 |
| Slow AWR (>60 sec) | 24 | 24 | 21 | 23 |
| Provoked Erythema | 0 | 2 | 9 | 0 |
| Sharply bordered AWR | 6 | 23 | 40 | 21 |
| AWR of Outer Vulvar Ring | 0 | 4 | 12 | 37 |
| AWR of Middle Vulvar Ring | 23 | 61 | 75 | 48 |
| AWR of Inner Vulvar Ring | 27 | 64 | 79 | 32 |
| Ring Sign | 6 | 31 | 67 | 9 |
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.
| second | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Velocity of the Aceto-Whitening Reaction (Mean ± SD) | 69.2 ± 24.3 | 54.9 ± 21.5 | 51.6 ± 21.2 | 65.9 ± 34.7 |
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.
| second | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Velocity of Aceto-Whitening Reaction (Median | Range) | 64.5 (30 to 120) | 51.5 (21 to 131) | 49 (16 to 120) | 58 (18 to 184) |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| AWR of Mons Pubis | 0 | 0 | 0 | 8 |
| AWR of Labia Majora | 0 | 0 | 4 | 20 |
| AWR of the Perineum | 0 | 4 | 10 | 31 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| AWR of the Anterior Commissure | 1 | 2 | 4 | 15 |
| AWR of Interlabial Sulci | 1 | 16 | 22 | 27 |
| AWR of Labia Minora | 6 | 20 | 43 | 27 |
| AWR of the Posterior Commissure | 23 | 53 | 72 | 40 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| AWR of the Clitoris | 8 | 35 | 73 | 20 |
| AWR of Hart's Line | 14 | 50 | 79 | 19 |
| AWR of the Urethral Sulcus | 16 | 49 | 73 | 21 |
| AWR of the Urethral Meatus | 6 | 38 | 70 | 14 |
| AWR of Hymenal Remnants | 6 | 33 | 69 | 14 |
| AWR of Bartholin's Gland Opening | 8 | 42 | 75 | 12 |
| AWR of the Vestibule | 21 | 49 | 76 | 23 |
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.
| Participants | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis |
|---|---|---|---|---|
| Hyperkeratosis | 0 | 6 | 3 | 62 |
| Parakeratosis | 3 | 5 | 7 | 30 |
| Acanthosis | 3 | 1 | 1 | 16 |
| Epidermal Atrophy | 0 | 0 | 0 | 25 |
| Inflammatory Infiltrates | 42 | 52 | 65 | 73 |
| Mononuclear Infiltrates | 33 | 46 | 61 | 63 |
| Lymphocytes | 9 | 3 | 3 | 13 |
| Mastocytes | 2 | 0 | 6 | 0 |
| Collagen Fibers | 7 | 1 | 9 | 44 |
| Hyalinization | 2 | 0 | 0 | 25 |
| Hyperpigmentation | 7 | 2 | 5 | 0 |
| Elongated Dermal Papillae | 5 | 7 | 0 | 1 |
| Blood Vessels | 31 | 30 | 53 | 5 |
| Sebaceous Glands | 39 | 48 | 61 | 1 |
| Nerve Fibers | 28 | 27 | 68 | 0 |
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.
| Participants | Vulvar Dermatosis With Normal Epidermis | Vulvar Dermatosis With Abnormal Epidermis |
|---|---|---|
| Dull / Slow Pain | 29 | 53 |
| Burning | 6 | 16 |
| Stinging | 24 | 41 |
| Soreness | 13 | 24 |
| Irritation | 12 | 23 |
| Itching | 28 | 51 |
| Inflammation | 13 | 25 |
| Aching | 8 | 13 |
| Sharp / Fast Pain | 3 | 9 |
| Knife-Like Pain | 0 | 5 |
| Paper-Cuts Pain | 1 | 2 |
| Stabbing | 2 | 4 |
| Sticking | 3 | 6 |
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.
| Participants | Vulvodynia With Normal Epidermis | Vulvodynia With Abnormal Epidermis |
|---|---|---|
| Dull / Slow Pain | 70 | 11 |
| Burning | 30 | 7 |
| Stinging | 57 | 9 |
| Soreness | 48 | 6 |
| Irritation | 39 | 9 |
| Itching | 54 | 9 |
| Inflammation | 41 | 8 |
| Aching | 38 | 7 |
| Sharp / Fast Pain | 22 | 9 |
| Knife-Like Pain | 7 | 6 |
| Paper-Cuts Pain | 6 | 4 |
| Stabbing | 12 | 5 |
| Sticking | 15 | 3 |
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.
| Participants | Vulvar Dermatosis 1 | Vulvar Dermatosis 2 |
|---|---|---|
| Inflammatory Infiltrates | 23 | 50 |
| Mononuclear Inflammatory Infiltrates | 19 | 44 |
| Lymphocytes | 5 | 8 |
| Mastocytes | 0 | 0 |
| Collagen Fibers | 11 | 33 |
| Hyalinization | 7 | 18 |
| Hyperpigmentation | 0 | 0 |
| Elongated Dermal Papillae | 0 | 1 |
| Blood Vessels | 1 | 4 |
| Sebaceous Glands | 0 | 1 |
| Nerve Fibers | 0 | 0 |
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.
| Participants | Vulvodynia 1 | Vulvodynia 2 |
|---|---|---|
| Inflammatory Infiltrates | 18 | 47 |
| Mononuclear Inflammatory Infiltrates | 16 | 45 |
| Lymphocytes | 1 | 2 |
| Mastocytes | 4 | 2 |
| Collagen Fibers | 1 | 8 |
| Hyalinization | 0 | 0 |
| Hyperpigmentation | 1 | 4 |
| Elongated Dermal Papillae | 0 | 0 |
| Blood Vessels | 14 | 39 |
| Sebaceous Glands | 22 | 39 |
| Nerve Fibers | 21 | 47 |
Collected over We collected the adverse event data from hospital admission up to 2 years after TRIV for each participant.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Vulva | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Impaired Vulvar Skin | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Vulvodynia | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Vulvar Dermatosis | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Age, Categorical(Participants) | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis | Total |
|---|---|---|---|---|---|
| <=18 years | 1 | 2 | 0 | 1 | 4 |
| Between 18 and 65 years | 81 | 79 | 82 | 66 | 308 |
| >=65 years | 0 | 1 | 0 | 15 | 16 |
| Age, Continuous(years) | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis | Total |
|---|---|---|---|---|---|
| Mean | 34.21 ± 10.01 | 34.44 ± 9.37 | 35.71 ± 7.97 | 51.11 ± 16.21 | 38.87 ± 10.89 |
| Sex: Female, Male(Participants) | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis | Total |
|---|---|---|---|---|---|
| Female | 82 | 82 | 82 | 82 | 328 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 82 | 82 | 82 | 82 | 328 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Normal Vulva | Impaired Vulvar Skin | Vulvodynia | Vulvar Dermatosis | Total |
|---|---|---|---|---|---|
| Croatia | 82 | 82 | 82 | 82 | 328 |
Plan to share: No
The record gives a start of Dec 2011, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2019, 2 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Lichen Sclerosus et Atrophicus →