Vaginal intraepithelial neoplasia (VAIN) Urological and Genital Diseases Vaginal intraepithelial neoplasia [VAIN], grade I
Conditions
Interventions
Group A: Follow-up with colposcopy, Pap smear, punch biopsy and hrHPV test 0, 4, 8 and 16 weeks.
Group B: Laser treatment and follow-up with colposcopy, punch biopsy and hrHPV test 4, 8 and 16 weeks.
Sponsors
Helsinki University Central Hospital (Finland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. A biopsy-confirmed VAIN1 that has persisted for two years or biopsy-confirmed VAIN2-3 2. Previously laser or surgically treated VAIN, when previous treatment has occurred over 1 month prior 3. Immune compromised patients (i.e. patients with rheumatoid arthritis, scleroderma, etc.) who frequently have VAIN 4. Patients of legal age (18 years old and above)
Exclusion criteria
Exclusion criteria: 1. Vaginal carcinoma 2. Pregnancy or breast-feeding 3. Lack of reliable contraception in premenopausal patients 4. Known allergy to imiquimod 5. Language difficulties (patients who do not speak sufficient Finnish or English) 6. Simultaneous need for Loop Electrosurgical Excision Procedure (LEEP) 7. HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histological regression to VAIN1 or less within 4 weeks of the end of treatment (week 16) will be considered a positive outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete histological regression 2. HPV-negativity (week 24) 3. Good tolerability of the treatment | — |
Countries
Finland
Outcome results
None listed