A Systematic Review of Outcomes Measures Evaluating Treatment Efficacy in Vulval Lichen Sclerosus

Abstract Aim Vulval lichen sclerosus (VLS) is an inflammatory skin disease characterised by pain, itching, burning, apareunia, loss of vulval architecture and scarring. Despite its detrimental effect on patients’ quality of life, the evidence on currently available treatments remains scarce. Significant heterogeneity in outcome reporting precludes evaluation and meaningful comparison of different treatment options. This study aims to systematically review the different outcome measures used to evaluate efficacy of all VLS treatments. Method This review followed PRISMA guidelines using a registered protocol (PROSPERO: CRD42022356738). Multiple databases were searched, along with grey literature on Clinicaltrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial registries. All randomised controlled studies (RCTs) assessing the outcomes of patients undergoing any treatment for VLS were eligible for inclusion. Results A total of 775 patients were assessed across 21 RCTs. The identified assessment tools reported outcomes in the following domains: patient-reported symptoms assessed with one validated scale in 12 studies and seven non-validated scales in nine studies; sexual function with validated FSFI and FSDS in two studies and two non-validated scales in two studies; quality of life with three validated scales in three studies; clinician-reported objective outcomes with two validated scales in three studies and six non-validated scales in fourteen studies. Histological changes were assessed in 10 studies and tissue biomechanics in one. Conclusions There is high heterogeneity in assessing treatment outcomes for LS. To appropriately evaluate and compare the effectiveness of VLS treatments it is crucial to adopt a core set of outcome measures in future studies.