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Circumcision Versus Preputioplasty for BXO in Children (BXO)

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ClinicalTrials.gov Identifier: NCT02854995
Recruitment Status : Completed
First Posted : August 4, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Balanitis Xerotica Obliterans (BXO) Procedure: circumcision Procedure: preputioplasty with intralesional injection of triamcinolone: Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Circumcision Versus Preputioplasty for BXO in Children: A Feasibility Randomised Controlled Trial
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : November 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854995


Locations
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United Kingdom
Alder Hey Children's Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust

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Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02854995     History of Changes
Other Study ID Numbers: BXO
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: October 2017
Additional relevant MeSH terms:
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Balanitis
Balanitis Xerotica Obliterans
Penile Diseases
Genital Diseases, Male
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action