Clinical and histological predictors of disease severity in BXO
Research type
Research Study
Full title
Clinical and Histological Predictors of Disease Severity in Balanitis Xerotica Obliterans (Lichen Sclerosus et atrophicus of the male genitalia): a prospective observational study
IRAS ID
294908
Contact name
Harriet J Corbett
Contact email
Sponsor organisation
Alder Hey Children's Hospital
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Balanitis xerotica obliterans (BXO, also known as Lichen sclerosus et atrophicus) is a chronic progressive inflammatory skin disease that affects the male penis. Inflammatory and scarring lesions form on the foreskin, glans and urethra, resulting in foreskin tightness and narrowing of the urethra. Diagnosis is clinical and is confirmed on histology. Treatment comprises surgical removal of the foreskin with topical medical therapies used alongside surgery. Following surgical treatment, up to 30% of patients require a further operation over a period of 0.5 – 2.0 years.
The aims of this project are to: 1) create clinical and histology grading systems for BXO, and to determine whether a relationship exists between the two; 2) to determine whether the clinical course of BXO can be predicted by clinical and histological features, and develop a model for predicting severe or relapsing disease.
Patients ≤16 years of age undergoing circumcision for suspected BXO will be recruited prospectively. Consent will be taken from the parent/guardian and, where appropriate the child, prior to surgery. Photographs of the penis, glans and urethral meatus will be taken during surgery. These will be scored for disease severity. The operating surgeon will also score the severity of the operative findings. Histological foreskin samples are taken routinely following circumcision for BXO. These samples will be scored for disease severity.
Participants will then be followed-up over a period of one year. Subsequent symptoms, medical treatments or repeat interventions will be recorded. The clinical severity scoring will be compared against the histological severity score. Patient demographic information, symptomatology, and clinical and histological features will be analysed to identify predictors of post-operative disease recurrence. These factors will then be used to develop a grading system for BXO. The study will take place at University Hospital Southampton, Alder Hey Children’s Hospital, Liverpool and Royal Manchester Children's Hospital, Manchester.
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0845
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion