Circumcision Versus Preputioplasty for BXO in Children

Balanitis Xerotica Obliterans (BXO) Clinical Trial

— BXO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854995
• Other study ID #: BXO
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: November 7, 2018

Study information

• Verified date: October 2017
• Source: Alder Hey Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 7, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Balanitis
• Balanitis Xerotica Obliterans (BXO)
• Lichen Sclerosus et Atrophicus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Alder Hey Children's Hospital	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Alder Hey Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Recruitment Rate including reasons for non-recruitment.	12 months
Primary	Protocol Adherence	Rate of adherence to protocol-data collected by study team	12 months
Primary	Drop Out	Rate of drop-out from the study	12 months
Secondary	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
Secondary	Clinical outcomes-Readmissions to hospital	Readmissions to hospital (number of readmissions within 30 days)	30 days
Secondary	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
Secondary	Clinical outcomes-Return to theatre	Return to theatre for a complication (within 30 days)	30 days
Secondary	Clinical outcomes-patient satisfaction	Medium term patient satisfaction (questionnaire at 3 months and 1 year)	3 months & 1 year
Secondary	Clinical outcomes-functional outcomes	Functional outcomes: urinary flow rate at 6 weeks, 3 months and 1 year	6 weeks, 3 months & 1 year
Secondary	Clinical outcomes-Subsequent penile surgery	Subsequent penile surgery (other than for early complication): e.g. meatal procedure, re-do preputioplasty or circumcision	1 year