Outpatient laser coagulation of intermediate-risk bladder tumor compared with TUR-BT, 12 months and long-term results of a noninferiority RCT

Introduction: Managing recurrent low-grade intermediate-risk bladder
tumors is burdensome for patients and healthcare systems. We
previously found outpatient department (OPD) photo coagulation of
bladder tumors (PC-BT) noninferior to the gold standard transurethral
resection of bladder tumors (TUR-BT) in general anesthesia regarding
4-month recurrence-free survival. PC-BT is associated with fewer
postoperative complications, better quality of life for patients and the
required health care resources per treatment are notably reduced. This
study aimed to compare 12-month recurrence-free survival between
PC-BT and TUR-BT, long-term recurrence-free survival, and tumor stage
progression.
Methods: From 2016 to 2022, a single-center randomized controlled trial
was conducted in Denmark, including 300 patients with histologically
verified Ta low-grade bladder tumor recurrence. Participants were
randomized 1:1 to either PC-BT with a 980 nm laser under local
anesthesia or TUR-BT under general anesthesia. Primary endpoint was
12-month recurrence-free survival with a noninferiority margin of 15%.
Secondary endpoints included long-term recurrence-free survival and
tumor stage progression, with a noninferiority margin for stage
progression set at 5%.
Results: At 12 months, recurrence-free survival was 42.2% for PC-BT and
44.1% for TUR-BT, with a difference of 1.9% (95% CI -9.3 to 13.2),
satisfying the noninferiority criterion. Median follow-up was 47.2 months
for PC-BT and 49.5 months for TUR-BT. Stage progression rates were
similar in the two groups with a difference of 0.16% (CI95%-0.024 to
0.027), satisfying the inferiority criterion. Long-term recurrence-free
survival showed no difference between groups.
Conclusion: PC-BT is a safe and effective alternative to TUR-BT for
treating recurrent Ta low-grade bladder tumors.