Treatment of vulval fibrosis in vulval lichen sclerosus Urological and Genital Diseases
Conditions
Interventions
This is a single-blind (blinded assessors) randomised controlled feasibility trial.
Trained members of the research team and clinical collaborators on the Delegation of responsibility log at Royal F
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Adults (>18 years) 2. Female sex 3. Patients who live in the UK 4. Patients with expert-diagnosed clinical and/or histological diagnosis of VLS 5. Able to give informed consent 6. Able to communicate in English 7. Structural changes secondary to VLS
Exclusion criteria
Exclusion criteria: 1. Active malignancy or previous diagnosis of intraepithelial neoplasia/carcinoma of the vulva 2. Previous vulval AFG or PRP 3. Body mass index 35.0 4. Contraindications to general anaesthetic 5. Active infection that precludes fat harvest, AFG or PRP injection 6. Pregnancy, breastfeeding or planning for pregnancy during the study period 7. Connective tissue and autoimmune diseases and diseases which affect the vulva
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment rate recorded as the proportion of eligible patients willing to be randomised measured using study records at one time point | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The average number of patients recruited per month and the total number of recruited patients at the end of the study measured using study records at one time point 2. The rate of withdrawal from the study, data collection completeness, and the impact of the distance travelled to the treatment centre on the patient retention rate are measured using study records at one time point 3. The acceptability of the proposed treatments to patients and clinicians is assessed throughout the study through qualitative interviews 4. Adherence to the trial protocol measured using patients’ steroid cream diaries and follow-up visit attendance and adequate timing of outcome assessments evaluated at the end of the study via qualitative questionnaires completed by clinicians and patients. 5. The feasibility of setting up a second treatment centre in Nottingham evaluated via qualitative questionnaires on cost, available expertise and facilities, and training needs and the evaluation of the number of centres required nationally to run a multicentre trial measured at the end of the study measured using the number of patients required to run an adequately powered randomised controlled trial, recruitment rate and proportion of patients willing to be randomised in this feasibility trial, expertise available nationally and patient availability (qualitative questionnaires disseminated in collaboration with national vulval lichen sclerosus organisations, dermatology and gynaecology associations). 6. The appropriate outcome assessments and their timing. Investigated measures will be assessed at baseline, 3 and 6 months and will include: 6.1. Patient-reported signs and symptoms – Vulvovaginal Symptom Questionnaire (VSQ), Visual assessment score (VAS) for soreness, itching, burning, dyspareunia, The Female Genital Self-Image Scale (FGSIS), Clinical Lichen Sclerosus Score (CLISSCO) subjective part, The Vulvar Pain Assessment Questionnaire (VPAQ), Pain Anxiety Symptom Scale Short Form 20 (PASS- | — |
Countries
England, United Kingdom
Contacts
Public ContactSara Jasionowska
Outcome results
None listed