Non-operative management of early onset small urethrocutaneous fistula post hypospadias repair: a systematic review

Clinical Snapshot

Key Findings

• P Value: Not reported at review level

• Effect Size: Individual study closure rates: 53.8% to 62.5% in primary case series; 100% in one anecdotal single-case report. No pooled effect size calculable.

• Primary Outcome: Fistula closure rate with non-operative management of small (≤2 mm) early-onset urethrocutaneous fistulas post-hypospadias repair

• Nnt Or Sensitivity: NNT not calculable. Cost signal: non-operative adhesive application estimated at approximately 9.3% of total operative repair costs (single RCT data point only — not generalisable without uncertainty quantification)

• Confidence Interval: Not reported; no meta-analytic pooling performed due to clinical heterogeneity

Clinical Application

Non-operative interventions (tissue adhesives, fibrin glue, recatheterisation) are technically accessible in paediatric urology and general surgical settings. However, standardised protocols for patient selection, application technique, monitoring, and criteria for escalation to surgery are not yet established. Specialist paediatric urology oversight is essential. In Australia, hypospadias repair is performed by paediatric urologists and paediatric surgeons, predominantly in tertiary children's hospitals. Urethrocutaneous fistula repair is a recognised complication managed under MBS item numbers for urethral reconstruction. Tissue adhesives such as cyanoacrylate and fibrin sealants (e.g., Tisseel, TGA-registered) are available in Australian hospitals. The RACGP and relevant specialist colleges have not issued specific guidelines on non-operative UCF management. Given the current evidence quality, non-operative approaches should not replace surgical referral as standard care but may be considered in selected cases under specialist guidance, particularly where repeated general anaesthesia poses elevated risk (e.g., children with comorbidities). PBS listing is not applicable to tissue adhesive application in this context. Families should be counselled that evidence remains preliminary. Male children under 18 years with small (≤2 mm diameter), early-onset urethrocutaneous fistulas diagnosed within 14 days of catheter removal following hypospadias repair, in whom surgical risk (particularly repeated anaesthesia) is a clinical concern

Abstract

BACKGROUND: Urethrocutaneous fistulas (UCF) after hypospadias repair are typically managed surgically, but conservative approaches may offer a less invasive, cost-effective alternative. While surgical repair remains the standard, non-operative strategies may eliminate anesthesia exposure, shorten recovery time, and lower healthcare costs. However, systematic evidence regarding these approaches remains limited. METHODS: This narrative systematic review evaluates non-operative management for small (typically ≤ 2 mm) UCFs. A comprehensive search was conducted across PubMed, Cochrane, ScienceDirect, Wiley, and Google Scholar up to April 2025. The study followed PRISMA guidelines and is registered in PROSPERO (CRD420251069870). We included randomized controlled trials (RCTs), comparative trials, case series, and anecdotal reports involving children (< 18 years). Risk of bias was assessed using Cochrane RoB-2, ROBINS-I, and JBI Critical Appraisal tools. RESULTS: Five studies involving 73 patients were included for analysis. Due to significant clinical heterogeneity in fistula characteristics and interventions, a pooled closure rate was not calculated. Reported individual study closure rates ranged from 53.8% to 62.5% in the primary series, with one anecdotal report (n = 1) showing 100% success. Success was more frequently observed in early-onset UCFs (diagnosed within 14 days post-catheter removal) and those with a diameter ≤ 2 mm. Minor adverse events included localized heat (42.8%) and transient dysuria (4.7%). Cost-analysis from one RCT indicated that non-operative adhesive application cost approximately 9.3% compared to total operative costs. Most included studies were classified as having a high risk of bias. CONCLUSION: Non-operative approaches using tissue adhesives, fibrin glue, or recatheterization may be viable for small (≤ 2 mm), early-onset UCFs. However, the current evidence is limited, heterogeneous, and carries a high risk of bias. These findings should be considered hypothesis-generating, and further high-quality comparative studies are required to establish definitive clinical protocols. TRIAL REGISTRATION: PROSPERO CRD420251069870.

References

1. 1.Simanjuntak, B. C., Raharja, P. A. R., Situmorang, G. R., Wahyudi, I., Rodjani, A., Aljarallah, O. S. A. J. H., Al-Salihi, M., Vallasciani, S. A., & Abbas, T. O. (2026). Non-operative management of early onset small urethrocutaneous fistula post hypospadias repair: a systematic review. World Journal of Urology. https://doi.org/10.1007/s00383-022-05109-y