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NCT Number: NCT02854995

Circumcision Versus Preputioplasty for BXO in Children

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.

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Key information

Conditions

Balanitis Xerotica Obliterans (BXO) Balanitis Balanitis Xerotica Obliterans Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Diseases

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alder Hey Children's Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circumcision

Procedure

(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.

preputioplasty with intralesional injection of triamcinolone:

Procedure

(ii) preputioplasty with intralesional injection of triamcinolone: this will be performed as described by Wilkinson et al.[5] 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.

Primary outcomes

  1. Recruitment Rate

    Time frame: 12 months

    Recruitment Rate including reasons for non-recruitment.

  2. Protocol Adherence

    Time frame: 12 months

    Rate of adherence to protocol-data collected by study team

  3. Drop Out

    Time frame: 12 months

    Rate of drop-out from the study

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 6 weeks, 3 months and 12 months

    Satisfaction with treatment process (at 6 weeks) and overall outcome (3 and 12 months) - data collected by questionnaire

  2. Clinical outcomes-Readmissions to hospital

    Time frame: 30 days

    Readmissions to hospital (number of readmissions within 30 days)

  3. Clinical outcomes-Surgical complications

    Time frame: 72 hours

    Surgical complications: specifically, wound infection (defined by intention to treat with antibiotics); urinary retention requiring intervention; post-operative bleeding requiring return to theatre

  4. Clinical outcomes-Return to theatre

    Time frame: 30 days

    Return to theatre for a complication (within 30 days)

  5. Clinical outcomes-patient satisfaction

    Time frame: 3 months & 1 year

    Medium term patient satisfaction (questionnaire at 3 months and 1 year)

  6. Clinical outcomes-functional outcomes

    Time frame: 6 weeks, 3 months & 1 year

    Functional outcomes: urinary flow rate at 6 weeks, 3 months and 1 year

  7. Clinical outcomes-Subsequent penile surgery

    Time frame: 1 year

    Subsequent penile surgery (other than for early complication): e.g. meatal procedure, re-do preputioplasty or circumcision

Sponsors and collaborators

Lead sponsor

Alder Hey Children's NHS Foundation Trust

Other

Registry information

Official study title

Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial

Acronym: BXO

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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