Abstract
Objectives
To determine: (i) feasibility for an RCT [randomized controlled trial] comparing circumcision to preputioplasty and intralesional triamcinolone (PIT) to treat Balanitis Xerotica Obliterans (BXO) and (ii) patient outcomes to inform future study design.
Patients and Methods
Approval was obtained from HRA/REC (16/NW/0364) and trial protocol registered (NCT02854995). Twenty boys (2-16 years) with BXO were randomized to either circumcision or PIT (online parallel group 1:1 allocation, non blinded). Exclusion criteria were: (i) previous penile surgery, (ii) contraindication for either treatment. Follow-up (including satisfaction questionnaire) was at 6 weeks, 3 and 12 months. Data are presented as median [IQR], continuous variables are compared by t-test.
Results
54 boys were approached over 18 months: 23 (45%) were recruited and randomised. The commonest reason for non-entry was treatment preference: 12 preferred circumcision, 18 preferred PIT. Four patients withdrew after randomisation, 3 did not want circumcision, 1 did not want PIT. The groups were similar in terms of age (11yrs [6-12] vs. 8yrs [7-10], p=0.53) and duration of symptoms (6m [6-15] vs.6m [2-24], p=0.77). There were no protocol breaches, serious adverse events or post-operative meatal stenosis. There was one self-resolving haematoma after PIT and one stitch granuloma after circumcision. Two boys went on to have a circumcision after PIT. Overall, satisfaction levels were high for both groups.
Conclusion
A definitive RCT of circumcision vs. PIT for BXO appears feasible, with 39% of those approached completing the trial. More families preferred PIT. A robust comparison in the form of a multi-centred RCT is required.