Preputioplasty Versus Circumcision For BXO In Children

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Accept all cookies See cookie policy Glossary Search glossary 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

  [email protected]

• 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

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