Circumcision Versus Preputioplasty for BXO in Children (BXO)

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.

Study Overview

• Status: Completed
• Conditions: Balanitis Xerotica Obliterans (BXO)
• Intervention / Treatment: Procedure: circumcision; Procedure: preputioplasty with intralesional injection of triamcinolone:

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).

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L12 2AP
      • Alder Hey Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: circumcision; (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.	Procedure: circumcision; (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.
Other: preputioplasty with intralesional injection of triamcinolone; (ii) preputioplasty with intralesional injection of triamcinolone: longitudinal incisions will be placed in the area of phimosis, and these will be sutured transversely to allow the prepuce to become retractile.	Procedure: preputioplasty with intralesional injection of triamcinolone: (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Recruitment Rate including reasons for non-recruitment.	12 months
Protocol Adherence	Rate of adherence to protocol-data collected by study team	12 months
Drop Out	Rate of drop-out from the study	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Satisfaction with treatment process (at 6 weeks) and overall outcome (3 and 12 months) - data collected by questionnaire	6 weeks, 3 months and 12 months
Clinical outcomes-Readmissions to hospital	Readmissions to hospital (number of readmissions within 30 days)	30 days
Clinical outcomes-Surgical complications	Surgical complications: specifically, wound infection (defined by intention to treat with antibiotics); urinary retention requiring intervention; post-operative bleeding requiring return to theatre	72 hours
Clinical outcomes-Return to theatre	Return to theatre for a complication (within 30 days)	30 days
Clinical outcomes-patient satisfaction	Medium term patient satisfaction (questionnaire at 3 months and 1 year)	3 months & 1 year
Clinical outcomes-functional outcomes	Functional outcomes: urinary flow rate at 6 weeks, 3 months and 1 year	6 weeks, 3 months & 1 year
Clinical outcomes-Subsequent penile surgery	Subsequent penile surgery (other than for early complication): e.g. meatal procedure, re-do preputioplasty or circumcision	1 year

Collaborators and Investigators

• Sponsor: Alder Hey Children's NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): November 7, 2018

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Penile Diseases; Balanitis; Balanitis Xerotica Obliterans; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: BXO