N/A
N=328
Diagnostic Accuracy of "Three Rings Vulvoscopy" for Detection of Vulvar Dermatosis
Lichen Sclerosus · Lichen Planus · Lichen Simplex Chronicus · Vulvodynia
Bottom Line
View on ClinicalTrials.gov: NCT02732145 ↗Enrolled (actual)
328
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis — 72; 0; 10; 246 Participants — p=0.6108
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- "Three Rings Vulvoscopy" (TRIV) (Diagnostic_test); Histopathology (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Ginekološka Poliklinika Dr. Vesna Harni
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "Vulvoscopy Index" for Detection of Vulvar Dermatosis |
72; 0; 10; 246 | 0.6108 |
| PRIMARY Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index" |
82; 72; 35; 31; 28; 24 | 1.0000 |
| PRIMARY Distribution of Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the "Vulvoscopy Index" |
82; 92; 74; 78; 104; 108 | 0.5399 |
| PRIMARY "Vulvoscopy Index" (Mean ± SD) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology |
4.0; 4.0; 1.28; 1.29; 0.68; 0.67 | 1.0000 |
| PRIMARY "Vulvoscopy Index" (Mean ± SD) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology |
1.33; 1.44; 0.90; 0.91; 0.85; 0.84 | — |
| PRIMARY "Vulvoscopy Index" (Median | Range) in Patients With "Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology |
4; 4; 0; 0; 0; 0 | 1.0000 |
| PRIMARY "Vulvoscopy Index" (Median | Range) in Patients With "Absent Vulvar Dermatosis" Diagnosed by Vulvoscopy (TRIV) and Histopathology |
0; 0; 0; 0; 0; 0 | 0.5403 |
| PRIMARY Diagnostic Accuracy of "Three Rings Vulvoscopy" by the "N-S-P Scheme" for Detection of Vulvar Dermatosis |
72; 0; 10; 246 | 0.6108 |
| PRIMARY Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology |
6; 5; 24; 22; 73; 64 | 0.9286 |
| PRIMARY Distribution of Vulvar Lesions According to the "N-S-P Scheme" in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology |
227; 228; 18; 20; 0; 9 | 0.2530 |
| SECONDARY Baseline Characteristics: Age |
34.2; 34.4; 34.2; 51.1 | 0.0000 sig |
| SECONDARY Baseline Characteristics: Weight |
61.9; 63.3; 61.1; 71.3 | 0.0000 sig |
| SECONDARY Baseline Characteristics: Height |
169.1; 168.7; 166.7; 167.5 | 0.0557 |
| SECONDARY Baseline Characteristics: BMI |
21.6; 22.3; 22.0; 25.4 | 0.0000 sig |
| SECONDARY Demographic Data in Patients With and Without Vulvar Discomfort |
0; 1; 0; 15; 82; 81 | 0.0000 sig |
| SECONDARY Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia |
82; 81; 22; 37; 65; 66 | 0.3158 |
| SECONDARY Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort |
81; 77; 73; 49; 1; 5 | 0.0000 sig |
| SECONDARY Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort |
1; 1; 73; 34; 80; 76 | 0.0000 sig |
| SECONDARY Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia |
49; 73; 0; 27; 16; 39 | 0.0000 sig |
| SECONDARY Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia |
21; 54; 7; 21; 19; 42 | 0.0000 sig |
| SECONDARY Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort |
54; 47; 74; 72; 7; 7 | 0.0000 sig |
| SECONDARY Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort |
52; 58; 79; 75; 13; 17 | 0.0000 sig |
| SECONDARY Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia |
33; 42; 26; 39; 10; 12 | 0.1583 |
| SECONDARY Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort |
10; 11; 73; 28; 2; 4 | 0.0000 sig |
| SECONDARY Distribution of Non-Specific and Specific Vulvar Lesions in Relation to The Three Vulvar Rings (TRIV) |
0; 4; 15; 58; 26; 71 | 0.0000 sig |
| SECONDARY Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the "Three Rings Vulvoscopy" |
0; 1; 2; 18; 0; 1 | 0.0000 sig |
| SECONDARY Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the "Three Rings Vulvoscopy" |
1; 7; 9; 30; 1; 32 | 0.0000 sig |
| SECONDARY Distribution of Non-Specific and Specific Lesions of the Inner Vulvar Ring According to the "Three Rings Vulvoscopy" |
8; 43; 76; 34; 21; 68 | 0.0000 sig |
| SECONDARY Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings |
38; 74; 81; 57; 38; 71 | 0.0000 sig |
| SECONDARY Velocity of the Aceto-Whitening Reaction (Mean ± SD) |
69.2; 54.9; 51.6; 65.9 | 0.0003 sig |
| SECONDARY Velocity of Aceto-Whitening Reaction (Median | Range) |
64.5; 51.5; 49; 58 | 0.0004 sig |
| SECONDARY Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring |
0; 0; 0; 8; 0; 0 | 0.0000 sig |
| SECONDARY Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Middle Vulvar Ring |
1; 2; 4; 15; 1; 16 | 0.0000 sig |
| SECONDARY Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Inner Vulvar Ring |
8; 35; 73; 20; 14; 50 | 0.0000 sig |
| SECONDARY Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort |
0; 6; 3; 62; 3; 5 | 0.0000 sig |
| SECONDARY Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis |
29; 53; 6; 16; 24; 41 | 0.0000 sig |
| SECONDARY Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia |
70; 11; 30; 7; 57; 9 | 0.0000 sig |
| SECONDARY Histopathological Features of Vulvar Dermis in Patients With Vulvar Dermatosis Depending On The Duration of Vulvar Discomfort |
23; 50; 19; 44; 5; 8 | 0.2045 |
| SECONDARY Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort |
18; 47; 16; 45; 1; 2 | 0.0045 sig |
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.
Eligibility Criteria
Inclusion Criteria
"Three Rings Vulvoscopy" performed at Poliklinika Harni, during the period from December 2011 - December 2016.
Ability to provide Informed Consent and complete Questionnaire.
Exclusion Criteria
Incomplete medical records. Lack of histopathology. Vulvo-vaginal infection. Benign tumors of the vulva. Pre-/malignant conditions of the vulva.
Data sourced from ClinicalTrials.gov (NCT02732145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.