Balanitis Xerotica Obliterans (BXO)BXONCT02854995
Circumcision Versus Preputioplasty for BXO in Children
A study testing circumcision and preputioplasty with intralesional injection of triamcinolone: in people with Balanitis Xerotica Obliterans (BXO), run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Balanitis Xerotica Obliterans (BXO)
- What is being tested?
- circumcision and preputioplasty with intralesional injection of triamcinolone:
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2016to 7 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged between 2 and 16 years
- diagnosed with BXO
- require surgery to treat BXO
Who cannot join
- previous penile surgery
- circumcision or preputioplasty medically contraindicated
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Alder Hey Children's Hospital
Liverpool, Merseyside, L12 2AP
About this study
Official title: 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.
Read the 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).
- Conditions
- Balanitis Xerotica Obliterans (BXO)
- Being tested
- circumcision, preputioplasty with intralesional injection of triamcinolone:
- Medical subject headings
- Balanitis Xerotica Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circumcisionProcedure or surgery
(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 or surgery
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: circumcision |
| 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. Receives: Procedure: preputioplasty with intralesional injection of triamcinolone: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment Rate including reasons for non-recruitment.
Measured: 12 months
Protocol Adherence
Rate of adherence to protocol-data collected by study team
Measured: 12 months
Drop Out
Rate of drop-out from the study
Measured: 12 months
Secondary outcomes (7)
Patient Satisfaction
Satisfaction with treatment process (at 6 weeks) and overall outcome (3 and 12 months) - data collected by questionnaire
Measured: 6 weeks, 3 months and 12 months
Clinical outcomes-Readmissions to hospital
Readmissions to hospital (number of readmissions within 30 days)
Measured: 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
Measured: 72 hours
Clinical outcomes-Return to theatre
Return to theatre for a complication (within 30 days)
Measured: 30 days
Clinical outcomes-patient satisfaction
Medium term patient satisfaction (questionnaire at 3 months and 1 year)
Measured: 3 months & 1 year
Clinical outcomes-functional outcomes
Functional outcomes: urinary flow rate at 6 weeks, 3 months and 1 year
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 Jan 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Balanitis Xerotica Obliterans (BXO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alder Hey Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854995
- Sponsor's protocol ID
- BXO
- Acronym
- BXO
- Status last verified
- Oct 2017
- First submitted
- 22 Jul 2016
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34110689
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02854995
- Acronym / sponsor ID
- BXO / BXO
- Conditions
- Balanitis Xerotica Obliterans (BXO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alder Hey Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| circumcision | Other | 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. |
| preputioplasty with intralesional injection of triamcinolone | Other | Procedure: 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. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged between 2 and 16 years
- diagnosed with BXO
- require surgery to treat BXO
Key exclusion criteria (2 listed)
- previous penile surgery
- circumcision or preputioplasty medically contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | circumcision |
| 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. | Procedure or surgery | preputioplasty with intralesional injection of triamcinolone |
Primary outcome
Recruitment Rate
Time frame: 12 months
Recruitment Rate including reasons for non-recruitment.
Protocol Adherence
Time frame: 12 months
Rate of adherence to protocol-data collected by study team
Drop Out
Time frame: 12 months
Rate of drop-out from the study
7 secondary outcomes
Patient Satisfaction
Time frame: 6 weeks, 3 months and 12 months
Clinical outcomes-Readmissions to hospital
Time frame: 30 days
Clinical outcomes-Surgical complications
Time frame: 72 hours
Clinical outcomes-Return to theatre
Time frame: 30 days
Clinical outcomes-patient satisfaction
Time frame: 3 months & 1 year
Clinical outcomes-functional outcomes
Time frame: 6 weeks, 3 months & 1 year
Clinical outcomes-Subsequent penile surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 34110689Lansdale 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing circumcision and preputioplasty with intralesional injection of triamcinolone: in people with Balanitis Xerotica Obliterans (BXO), run by Alder Hey Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02854995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.