Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis

NCT02732145 | Completed Results

• 1 other identifier: PH20111201001
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lichen Sclerosus; Lichen Planus; Lichen Simplex Chronicus; Vulvodynia

Keywords

Three-Vulvar-Rings; Three-Rings-Vulvoscopy; N-S-P scheme; Vulvoscopy Index; Vulvar Dermatosis; Vulvar Lichen Sclerosus; Lichen Planus; Lichen Simplex Chronicus; Vulvodynia; Provoked Vestibulodynia; Vulvar Vestibulitis; Vulvar Diseases

Outcome Measures

Primary Outcomes (10)

• 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."

  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).

  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).

  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.

  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.

  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.

  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.

  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").

  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.

  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."

  ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.

Secondary Outcomes (29)

• 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.

• Baseline Characteristics: BMI

  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.

Study Arms (4)

Normal vulva

PLACEBO COMPARATOR

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

Impaired vulvar skin

PLACEBO COMPARATOR

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

Vulvodynia

PLACEBO COMPARATOR

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

Vulvar dermatosis

ACTIVE COMPARATOR

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

Interventions

"Three Rings Vulvoscopy" (TRIV) DIAGNOSTIC_TEST

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

Impaired vulvar skin; Normal vulva; Vulvar dermatosis; Vulvodynia

Histopathology PROCEDURE

Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.

Also known as: Biopsy of the Vulva

Impaired vulvar skin; Normal vulva; Vulvar dermatosis; Vulvodynia

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• "Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December 2016.
• Ability to provide Informed Consent and complete Questionnaire.

You may not qualify if:

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

Sponsors & Collaborators

• Ginekološka Poliklinika Dr. Vesna Harni: lead
• Klinički Bolnički Centar Zagreb: collaborator
• University of Zagreb: collaborator

Study Sites (1)

Poliklinika Harni

Zagreb, HR-10000, Croatia

Location

Related Publications (9)

• Moyal-Barracco M, Wendling J. Vulvar dermatosis. Best Pract Res Clin Obstet Gynaecol. 2014 Oct;28(7):946-58. doi: 10.1016/j.bpobgyn.2014.07.005. Epub 2014 Jul 18.

  PMID: 25132276 BACKGROUND

• Doyen J, Demoulin S, Delbecque K, Goffin F, Kridelka F, Delvenne P. Vulvar skin disorders throughout lifetime: about some representative dermatoses. Biomed Res Int. 2014;2014:595286. doi: 10.1155/2014/595286. Epub 2014 Jan 8.

  PMID: 24511539 BACKGROUND

• Ball SB, Wojnarowska F. Vulvar dermatoses: lichen sclerosus, lichen planus, and vulval dermatitis/lichen simplex chronicus. Semin Cutan Med Surg. 1998 Sep;17(3):182-8. doi: 10.1016/s1085-5629(98)80012-6.

  PMID: 9759675 BACKGROUND

• McKay M. Vulvar dermatoses: common problems in dermatological and gynaecological practice. Br J Clin Pract Suppl. 1990 Sep;71:5-10.

  PMID: 2091734 BACKGROUND

• O'Keefe RJ, Scurry JP, Dennerstein G, Sfameni S, Brenan J. Audit of 114 non-neoplastic vulvar biopsies. Br J Obstet Gynaecol. 1995 Oct;102(10):780-6. doi: 10.1111/j.1471-0528.1995.tb10842.x.

  PMID: 7547733 BACKGROUND

• Cooper SM, Ali I, Baldo M, Wojnarowska F. The association of lichen sclerosus and erosive lichen planus of the vulva with autoimmune disease: a case-control study. Arch Dermatol. 2008 Nov;144(11):1432-5. doi: 10.1001/archderm.144.11.1432.

  PMID: 19015417 BACKGROUND

• Raspollini MR, Asirelli G, Moncini D, Taddei GL. A comparative analysis of lichen sclerosus of the vulva and lichen sclerosus that evolves to vulvar squamous cell carcinoma. Am J Obstet Gynecol. 2007 Dec;197(6):592.e1-5. doi: 10.1016/j.ajog.2007.04.003. Epub 2007 Aug 21.

  PMID: 17714682 BACKGROUND

• Shier M, El-Khatib S. Vulvar lichen sclerosus. J Obstet Gynaecol Can. 2010 Oct;32(10):929-30. doi: 10.1016/s1701-2163(16)34676-x. No abstract available. English, French.

  PMID: 21176300 BACKGROUND

• Petersen CD, Kristensen E, Lundvall L, Giraldi A. A retrospective study of relevant diagnostic procedures in vulvodynia. J Reprod Med. 2009 May;54(5):281-7.

  PMID: 19517691 BACKGROUND

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus; Lichen Planus; Neurodermatitis; Vulvodynia; Vulvar Lichen Sclerosus; Vulvar Vestibulitis; Vulvar Diseases

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis

Results Point of Contact

• Title: Dr. Vesna Harni
• Organization: Ginekološka poliklinika Dr. Vesna Harni

vesnaharni@gmail.com

0038512923648

Study Officials

• Vesna Harni, MD

  Poliklinika Harni, Bukovacka 1, HR-10000 Zagreb, Croatia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Vesna Harni

Model Details: We performed the same interventions: Three Rings Vulvoscopy, Vulvar Biopsy and Histopathologically Evaluation in four groups of patients with and without vulvar discomfort, with the aim to detect vulvar dermatosis.

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: April 8, 2016
• Study Start: December 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 30, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)