Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer
Bladder Cancer
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring bladder cancer, NMIBC, Pseudomonas aeruginosa
Eligibility Criteria
Inclusion criteria: Age ≥18 years old, both male and female; Diagnosed as Intermediate or high risk non-muscle invasive bladder cancer, with previous recurrent pathological diagnosis report and cystoscopy available. Intermediate risk was defined as the presence of one or two of the following: multiple tumors, single tumor larger than 3cm, and/or recurrence (≥1 event in low-risk NMIBC within 1 year after diagnosis). High risk was defined as meeting any one of the following: T1 tumor, G3 tumor, carcinoma in situ (CIS), multiple, recurrent and large (> 3cm) TaG1G2/ low-risk tumor (simultaneous); Not receiving BCG or other immune drug infusion chemotherapy at the same time Informed consent and signed informed consent form by patients and their families; Clear consciousness and able to answer questions independently, Patients were asked to complete the questionnaire by themselves; No history of neurological diseases, severe hematological diseases, and dysfunction of heart, lung, liver, or kidney were observed. Exclusion criteria: Patients with other genitourinary system tumors or other organ tumors; Patients with muscle invasive bladder urothelial carcinoma (≥T2); Patients receiving chemotherapy, radiotherapy or immunotherapy within the past 4 weeks (excluding immediate postoperative intravesical chemotherapy); Pregnant or lactating women, women of childbearing age who did not use effective contraception, and those who planned to become pregnant during the trial (including the partner of male subjects); Known or suspected intraoperative bladder perforation; Gross hematuria was present before enrollment, and the surgical wound was suspected to be unhealed or damaged urinary mucosa; Patients with cystitis, or previous treatment with other intravesical agents, whose bladder irritation significantly affected the evaluation of the study; Patients who had participated in a clinical trial with other drugs within 3 months before enrollment; Patients with known opioid or alcohol dependence; Patients with any condition considered by the investigators to increase the risk of the subject or interfere with the conduct of the trial;
Sites / Locations
- Qilu hospitalRecruiting
Arms of the Study
Arm 1
Experimental
Pseudomonas aeruginosa Group