Efficacy and Safety of Pseudomonas Aeruginosa for Intermediate and High-risk Non-muscle Invasive Bladder Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

August 1, 2025

Study Completion Date

December 1, 2025

Conditions
Bladder Cancer
Interventions
DRUG

Pseudomonas aeruginosa

A total of 63 subjects with intermediate and high risk NMIBC who were scheduled for transurethral resection of bladder tumor (TURBT) from March 2023 in three centers were enrolled in this study. The enrolled patients received submucosal injection of 1U of Pseudomonas aeruginosa injection and bladder irrigation with chemotherapy drugs (gemcitabine, mitomycin C, epirubicin or pirarubicin) immediately after TURBT. After urine was cleared, a sterile urinary catheter was placed, and 10U of Pseudomonas aeruginosa injection and 40ml of normal saline were injected. The perfusion solution was kept for 1 hour, and the position was changed every 20 minutes. The treatment was given once within 24 hours after operation, then once a week for 12 weeks, and then once a month for 12 months in total. Patients were followed up every 3 months after surgery. The last follow-up was completed in February 2025

Trial Locations (1)

276600

RECRUITING

Qilu hospital, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER