Preputioplasty Versus Circumcision for BXO in Children
Research type
Research Study
Full title
Preputioplasty versus Circumcision for BXO in Children: a Feasibility Randomised Controlled Trial
IRAS ID
193386
Contact name
Nicholas Lansdale
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Balanitis xerotica obliterans (BXO) is a chronic inflammatory condition affecting the penis. It affects between 0.01-0.07% of pre-pubertal boys. BXO frequently results in the foreskin not being able to be pulled back: this can cause symptoms such as pain and itching, but may also result in difficulty passing urine. If the BXO involves the head of the penis, the opening to pass urine through can become narrowed. When BXO is severe, it may result in an inability to pass urine at all: this requires emergency catheterisation or surgery.
Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this approach has long been considered the best treatment. Whilst this may be curative for many, it has been shown that 20% of boys require a further operation to widen the urethral opening.
An alternative to circumcision has been developed: this involves an operation called preputioplasty (widening of the opening of the foreskin), combined with injection of steroids. When used in boys with BXO, it avoided circumcision in 92%. This approach may offer a further benefit of reducing the risk of narrowing of the urethral opening and hence further surgery.
Ultimately, a clinical trial is needed to robustly compare preputioplasty and circumcision in order to determine which is the best treatment. This study is required first to see whether or not a definitive trial is feasible. Specifically, it will look to see if boys and their families are willing to enrol in a trial and whether they find it acceptable to be randomly allocated to one of the operations. It will also collect data to see how large a future trial should be and find out what this trial should be measuring.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0364
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion