Balanitis Xerotica Obliterans (BXO) Clinical Trial
Official title:
Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial
Traditionally, BXO is managed with circumcision (surgical removal of the foreskin) and this
approach has long been held as the 'gold standard. Whilst this may be curative in many cases,
it has been shown that 20% of boys require a further operative procedure on their penis to
widen the urethral opening (to treat meatal stenosis)
An alternative to circumcision was proposed: a preputioplasty (surgery to widen the opening
of the foreskin) was combined with injection of steroids into the affected foreskin.
Subsequently, the same group compared the outcomes of this technique with circumcision, and
reported circumcision was successfully avoided in 92% of the preputioplasty group. In
addition, the rate of meatal stenosis (narrowing of the urethral opening requiring surgery)
was significantly lower (6% vs 19%, P = .034 ). Preputioplasty may therefore: (i) offer
protection against meatal stenosis and reduce the requirement for further surgery; and (ii)
offer the benefit of retaining the foreskin, the function of which, while debated, likely
includes sexual function. In view of these potential benefits, authors have called for a
randomised trial to compare circumcision to preputioplasty and injection of steroids.
The interventions to be compared are operations to treat BXO called:
(i) circumcision: this will be a standard surgical circumcision whereby the prepuce (foreskin
of the penis) is excised and the cut edge of the outer prepuce sutured to the cut edge of the
inner prepuce. The two study team members performing the surgery in this trial (HC and SK)
will be free to choose the method of circumcision (e.g. guillotine vs. sleeve) as this is not
thought to influence outcome. The foreskin will be sent for histological analysis.
(ii) preputioplasty with intralesional injection of triamcinolone. Briefly, longitudinal
incisions will be placed in the area of phimosis, and these will be sutured transversely to
allow the prepuce to become retractile. A biopsy of an area of affected foreskin will be sent
for histological analysis. The intention will be to perform three incisions (tri-radiate) but
the final decision on how many will be made by the operating surgeon and based on the
appearance of the prepuce and result of initial incision(s). Once the prepuce is felt to be
freely retractile, 1 - 3 mL of triamcinolone (Adcortyl Bristol-Myers Squibb 10 mg/mL) will be
injected intradermally around the circumference of the affected foreskin using a 25-gauge
needle.
These procedures are established treatments for BXO and currently in use by the trial
surgeons in the same setting as the trial.The preputioplasty with injection of triamcinolone
procedure has previously been approved by the Alder Hey Children's Hospital NHS Trust
Clinical Development Evaluation Group (CDEG).
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