Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
研究概览
简要总结
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.
详细描述
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •"Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December
- •Ability to provide Informed Consent and complete Questionnaire.
排除标准
- •Incomplete medical records. Lack of histopathology. Vulvo-vaginal infection. Benign tumors of the vulva. Pre-/malignant conditions of the vulva.
研究组 & 干预措施
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.
干预措施: "Three Rings Vulvoscopy" (TRIV) (Diagnostic Test)
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.
干预措施: Histopathology (Procedure)
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.
干预措施: "Three Rings Vulvoscopy" (TRIV) (Diagnostic Test)
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.
干预措施: Histopathology (Procedure)
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.
干预措施: "Three Rings Vulvoscopy" (TRIV) (Diagnostic Test)
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.
干预措施: Histopathology (Procedure)
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.
干预措施: "Three Rings Vulvoscopy" (TRIV) (Diagnostic Test)
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.
干预措施: Histopathology (Procedure)
结局指标
主要结局
Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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.
Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
时间窗: 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).
Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "N-S-P Scheme" for Detection of Vulvar Dermatosis
时间窗: 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").
Distribution of Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index"
时间窗: 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).
"Vulvoscopy Index" (Median | Range) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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.
"Vulvoscopy Index" (Median | Range) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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.
"Vulvoscopy Index" (Mean ± SD) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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.
"Vulvoscopy Index" (Mean ± SD) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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.
Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis
时间窗: 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."
Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology
时间窗: 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."
次要结局
- Baseline Characteristics: Age(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Baseline Characteristics: Weight(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Baseline Characteristics: Height(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the "Three Rings Vulvoscopy"(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"(Three Rings Vulvoscopy, up to 45 minutes for each participant.)
- Baseline Characteristics: BMI(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Demographic Data in Patients With and Without Vulvar Discomfort(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the "Three Rings Vulvoscopy"(Three Rings Vulvoscopy, up to 45 minutes for each participant.)
- Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring(Aceto-Whitening Test, up to 10 minutes for each participant.)
- Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort(Histopathological Examination, up to 30 minutes for each vulvar sample.)
- Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort(ISSVD Questionnaire, up to 30 minutes for each participant.)
- Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort(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)(Three Rings Vulvoscopy, up to 45 minutes for each participant.)
- Velocity of the Aceto-Whitening Reaction (Mean ± SD)(Aceto-Whitening Test, up to 10 minutes for each participant.)
- Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis(Histopathological Examination, up to 30 minutes for each vulvar sample.)
- Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings(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(Aceto-Whitening Test, up to 10 minutes for each participant.)
- Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia(Histopathological Examination, up to 30 minutes for each vulvar sample.)
- Velocity of Aceto-Whitening Reaction (Median | Range)(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(Aceto-Whitening Test, up to 10 minutes for each participant.)
- Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort(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(Histopathological Examination, up to 30 minutes for each vulvar sample.)
研究者
Vesna Harni
Dr. med. Vesna Harni
Ginekološka Poliklinika Dr. Vesna Harni