A stent-plus-irrigation protocol after adolescent hypospadias repair: a multicentre randomised controlled trial.
Summary
This multicentre randomized controlled trial included 150 adolescents undergoing hypospadias repair. Compared with catheter drainage alone, the combined stent-plus-irrigation protocol reduced overall complications (risk ratio 0.33), urethral fistula (risk ratio 0.27), and surgical site infection (risk ratio 0.43). The trial provides clinically meaningful postoperative evidence, although the independent effects of stenting and irrigation cannot be separated.
Key Findings
- A total of 150 adolescents were included in the final analysis, with 75 assigned to each group.
- The stent-plus-irrigation protocol reduced overall postoperative complications compared with catheter drainage alone: risk ratio 0.33, 95% confidence interval 0.20-0.56, P<0.001.
- Urethral fistula and surgical site infection were also reduced, with risk ratios of 0.27 and 0.43, respectively.
Clinical Implications
A combined small-calibre urethral stent and twice-daily saline irrigation protocol may be considered after adolescent hypospadias repair in appropriately selected patients. Before routine adoption, clinicians should consider local resources, patient adherence, and confirmation in larger trials with separate intervention components.
Why It Matters
This is a multicentre randomized trial addressing a modifiable postoperative protocol with substantial effects on fistula and infection rates. It may directly inform postoperative care, although a factorial or component-specific design is needed before attributing benefit to either stenting or irrigation alone.
Limitations
- The two-component intervention prevents determination of the independent effects of the stent and irrigation.
- The abstract does not provide detailed information on blinding, allocation concealment, long-term cosmetic outcomes, or the duration of follow-up.
Future Directions
Future trials should use factorial or multi-arm designs to separate the effects of stenting and irrigation, include standardized long-term urinary and cosmetic outcomes, and evaluate patient-reported burden and cost-effectiveness.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Multicentre randomized controlled trial with 150 participants analyzed.
- Study Design
- OTHER