A prospective randomized controlled multicenter clinical study comparing HOLTUR and TURis in patients with non-muscle invasive bladder cancer

Objective Compare the efficacy and safety of transurethral holmium laser resection of non-muscle invasive bladder tumor(HOLTUR) with transurethral resection in saline(TURis) method. Method From April 2010 to December 2014, in urology department of three different comprehensive medical center 120 cases of non-muscle invasive bladder cancer patients (111 male, 9 female) were admitted; aged from 36 to 75 years old. The patients were randomized divided into two groups: holmium laser resection(HOLTUR) group (60 cases) and bipolar transurethral resection in saline(TURis) group (60 cases). HOLTUR group included 56 male and 4 female patients. In HOLTUR group 45 patients had single tumor in bladder, 15 patients had multiple tumors(2-4) in bladder; Tumor location: left and right wall 40cases(66.7%), anterior wall 5 cases(8.3%), posterior wall 8 cases(13.3%), trigone 4 cases(6.7%), bladder neck 3 cases(5.0%). TURis group included 55 male and 5 female patients. In TURis group 42 patients had single tumor in bladder, 18 patients had multiple tumors(2-4) in bladder(P=0.888). Tumor location: left and right wall 38 cases(63.3%), anterior wall 3 cases(5.0%), posterior wall 10 cases(16.7%), trigone 4 cases(6.7%), Neck 5 cases(8.3%). There is no statistical difference between 2 groups(P>0.05). The surgery method: ①HOLTUR change the holmium laser rate to 16Hz, energy to 1J. The bladder was examined with Olympus cystoscopy to confirm the tumor size and location. The holmium laser was used to resect the tumor 1cm far from the tumor edge and its base to the bladder deep muscle. We also used holmium laser for hemostasis. For little bladder tumor we used holmium laser to vaporize the tumor directly after biopsy.②TURis: We use the olympus bipolar resectoscope to examine the bladder and confirm the location and size of tumor. Then we resected the tumor piece by piece until the deep muscle of bladder. And we used the TURis for hemostasis. The perioperative data of two groups were collected and compared. Perioperative data included the operation time, the obturator reflex incidence, bladder perforation incidence , catheterization time , postoperative hospital stay , tumor recurrence rate 3 months after surgery. Results All of the surgery were successful done. There were statistical difference(P 0.05) of urinary catheter retention time(1.7±0.2)days vs.(1.6±0.2)days, (P=0.666), postoperative hospital stay(3.4±0.3)days vs.(3.9±0.2)days, (P=0.150)and recurrence rate 3 months after surgery(5/60 vs.7/60, P=0.762) between HOLTUR and TURis group. Conclusions Compared with TURis, transurethral holmium laser resection of non-muscle invasive bladder cancer has shorter operation time, no obturator nerve reflex, and less complications. It is a safe and reliable methods for the bladder tumor. Key words: Bladder urothelium carcinoma; Holmium laser; Bipolar transurethral resection in saline; Randomized control research; Multiple center