Circumcision Versus Preputioplasty for BXO in Children
BXO
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 4, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2018
CompletedNovember 9, 2018
October 1, 2017
1.3 years
July 22, 2016
November 8, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Patient Satisfaction
6 weeks, 3 months and 12 months
Clinical outcomes-Readmissions to hospital
30 days
Clinical outcomes-Surgical complications
72 hours
Clinical outcomes-Return to theatre
30 days
Clinical outcomes-patient satisfaction
3 months & 1 year
- +2 more secondary outcomes
Study Arms (2)
circumcision
OTHER(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.
preputioplasty with intralesional injection of triamcinolone
OTHER(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.
Interventions
(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: 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.
Eligibility Criteria
You may qualify if:
- aged between 2 and 16 years
- diagnosed with BXO
- require surgery to treat BXO
You may not qualify if:
- previous penile surgery
- circumcision or preputioplasty medically contraindicated
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alder Hey Children's Hospital
Liverpool, Merseyside, L12 2AP, United Kingdom
Related Publications (1)
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.
PMID: 34110689DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2016
First Posted
August 4, 2016
Study Start
October 1, 2016
Primary Completion
January 31, 2018
Study Completion
November 7, 2018
Last Updated
November 9, 2018
Record last verified: 2017-10