Evaluation of thulium laser endoscopic en bloc resection versus conventional trans-urethral en bloc resection of primary non-muscle invasive bladder cancer: a randomized controlled trial.

PURPOSE: To compare thulium laser endoscopic en bloc resection (TmLRBT) with bipolar transurethral en bloc resection (bERBT) for primary non-muscle-invasive bladder cancer.

METHODS

In this multicenter, parallel-group randomized controlled trial, adults with primary urothelial tumors <3 cm and no clinical muscle invasion or metastasis were allocated 1:1 to TmLRBT or bERBT. The primary outcome was 12-month recurrence-free survival, assessed as recurrence-free status at 12 months and supported by time from index surgery to first documented bladder tumor recurrence or censoring within 12 months.

RESULTS

Of the 69 patients assessed, 56 were randomized; 50 completed 12-month follow-up and were included in the complete case analysis. TmLRBT improved mean recurrence-free survival (11.6 ± 1.3 vs 10.0 ± 3.1 months; MD +1.60; 95% CI +0.23 to +2.97; p=0.023). Twelve-month recurrence was significantly lower after TmLRBT than bERBT (4/25 [16.0%] vs 12/25 [48.0%]; RR 0.33, 95% CI 0.12-0.89; p=0.032). TmLRBT prolonged surgery but reduced catheterization, hospitalization, irrigation, and obturator reflex, with no intraoperative bleeding, moderate postoperative bleeding, perforation, postoperative complications, or procedure-related deaths.

CONCLUSION

TmLRBT was associated with improved 12-month recurrence outcomes, longer mean recurrence-free survival, and favorable perioperative safety compared with bERBT.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT06818799, retrospectively registered February 10, 2025.