ChiCTR1900026643.

Study name	The randomized controlled study for intravesical instillation of Pseudomonas aeruginosa and gemcitabine in the prevention of postoperative recurrence of non‐muscle invasive bladder cancer
Methods	Open‐label parallel randomized study
Participants	Estimated enrollment: 80 participants Eligible ages: ages > 18 and < 75 years Eligible sexes: both Eligibility criteria Inclusion criteria Person informed and has given written informed consent Ages 18 years to < 75 years, both men and women People undergoing TURBT Preoperative diagnosis is NMIBC (Ta‐T1N0M0), pathologic diagnosis of urothelial carcinoma No previous history of other malignant tumors Exclusion criteria Tumor invading the ureter, prostate, and urethra Incapable or behavioral capacity limited Preoperative routine chest X‐ray and pelvic enhancement CT examination revealed that distant metastasis or intraoperative findings of tumor invasive muscle layer Have other serious diseases, including cardiovascular, respiratory, kidney, or liver diseases, and uncontrolled hypertension and diabetes Pregnant and lactating women History of pelvic surgery or lower urinary tract surgery Preoperative history of chemotherapy Severe coagulation function, abnormal electrolyte balance disorder, hypoproteinemia corrected without obvious improvement Narcotic contraindications for the anaphylaxis of narcotic drugs Researcher considers that there are any other circumstances that are not suitable for participating in the study
Interventions	Intervention Gemcitabine: dose and schedule not specified Comparator Pseudomonas aeruginosa: dose and schedule not specified
Outcomes	Postoperative recurrence rate
Starting date	20 November 2019 Expected date of completion: 20 November 2021
Contact information	Applicant: Li Jiashuo; tel: +8615779750929; email: 505684933@qq.com Study leader: Shang Panfeng; tel: +8613919785295; email: shangpf@lzu.edu.cn
Notes	Funding source: subproject of the key research and development project in Gansu Province. Quote: "Regularization and diagnosis of cystatin cancer and promotion and application of different urinary diversion procedures." Sponsors and collaborators: Lanzhou University Second Hospital