Clinical trial NCT02854995: Circumcision Versus Preputioplasty for BXO in Children
Official title: Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balanitis Xerotica Obliterans (BXO)
Lead sponsor: Alder Hey Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* aged between 2 and 16 years
* diagnosed with BXO
* require surgery to treat BXO

Exclusion Criteria:

* previous penile surgery
* circumcision or preputioplasty medically contraindicated

Primary outcomes:
measure: Recruitment Rate
timeFrame: 12 months
measure: Protocol Adherence
timeFrame: 12 months
measure: Drop Out
timeFrame: 12 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 weeks, 3 months and 12 months
measure: Clinical outcomes-Readmissions to hospital
timeFrame: 30 days
measure: Clinical outcomes-Surgical complications
timeFrame: 72 hours
measure: Clinical outcomes-Return to theatre
timeFrame: 30 days
measure: Clinical outcomes-patient satisfaction
timeFrame: 3 months & 1 year
measure: Clinical outcomes-functional outcomes
timeFrame: 6 weeks, 3 months & 1 year
measure: Clinical outcomes-Subsequent penile surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: Merseyside
Study officials:
References:
citation: Lansdale N, Arthur F, Corbett HJ. Circumcision versus preputioplasty for balanitis xerotica obliterans: a randomised controlled feasibility trial. BJU Int. 2021 Dec;128(6):759-765. doi: 10.1111/bju.15508. Epub 2021 Jul 11.