Standardising Assessment of Meatal Stenosis
Research type
Research Study
Full title
The SAMPLE Study: Standardisation of Clinical Assessment of Meatal Stenosis Using a Validated Scoring System in Males Having Surgical Treatment of Paediatric Lichen Sclerosus Et Atrophicus
IRAS ID
329901
Contact name
Harriet J Corbett
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Boys who have undergone circumcision have a higher risk of developing a narrow 'wee hole', known as meatal stenosis. Lichen sclerosus (commonly called BXO) is skin condition that affects the end of the penis, most boys have a circumcision and some then develop meatal stenosis. The number of boys who need more surgery for meatal stenosis is unclear, figures given in published studies vary from less than 1 in 20 to as many as 1 in 5. There are likely to be a number of reasons for this variability including different thresholds for intervention between surgeons. At the current time there is no standardised grading system for meatal stenosis in boys treated for BXO.
Mekayten and colleagues have developed a grading system for meatal stenosis which is common in their patient population due high rates of non-therapeutic childhood circumcision (for cultural reasons). Their grading system has not yet been used in boys with BXO but has been validated in boys with meatal stenosis after circumcision for other reasons. The aim of this study is to validate Mekayten's grading system in boys with BXO. Once that has been done, we plan to design a study which will investigate which boys need further surgery for meatal stenosis and which do not, hopefully reducing variation in treatment.
This study will recruit boys who participated in the CHAPS (Clinical and histological predictors of disease severity in BXO) study for whom there are suitable photographs of the meatus. The study will also recruit boys undergoing meatal surgery during which standardised photographs of the meatus will be taken. The photographs will be anonymised and then scored by surgeons across the UK. Inter and intra-grader scores will be analyzed to determine if the meatal stenosis grading system is valid.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
24/SW/0086
Date of REC Opinion
28 Aug 2024
REC opinion
Further Information Favourable Opinion