Bladder cancer is the most common malignant tumor of the urinary system in China, and its incidence has been increasing year by year. It is classified into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). NMIBC accounts for 75% of newly diagnosed bladder cancer cases, and transurethral resection of bladder tumor (TURBT) followed by postoperative intravesical therapy is the standard treatment for NMIBC. However, the 5-year recurrence rate of NMIBC remains as high as 50%, with 20-30% of patients progressing to MIBC. MIBC is characterized by rapid progression and a high tendency for metastasis. The 5-year survival rate for patients with metastatic bladder cancer is only 5.4%. This study aims to investigate the efficacy of submucosal injection of the chemotherapeutic agent gemcitabine in preventing recurrence of intermediate- and high-risk NMIBC. Additionally, it seeks to develop software and devices related to submucosal injection to promote the clinical application of this new approach in the chemotherapeutic management of NMIBC. This research is expected to bring a revolutionary breakthrough in the standardisation of whole-process diagnosis and treatment of NMIBC, holding significant scientific value and major clinical translational importance for improving therapeutic outcomes and prognosis of bladder cancer.
Patients aged 18 to 80 years (inclusive) with radiologically confirmed bladder tumor and scheduled to undergo transurethral resection of bladder tumor (TURBT).
Postoperative pathological confirmation of intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC).
Voluntarily participate in the study and sign the informed consent form, ensuring the patient fully understands the trial purpose, risks, and right to withdraw.
Preoperative comorbidities including detrusor overactivity, urethral stricture, urge incontinence, stress incontinence, or overflow incontinence.
Concurrent urogenital infectious diseases (e.g., acute urethritis, acute cystitis).
History of pelvic radiotherapy.
Receiving systemic anti-tumor therapy for any malignant tumor.
Parallel
Gemcitabine Submucosal Injection
DrugA chemotherapeutic agent. Administered via submucosal injection into the bladder wall using a specialized injection gun. Dosage: 1000mg per injection. Regimen: One injection immediately post-TURBT, followed by one injection every three months for a total of four injections.
Gemcitabine Intravesical Instillation
DrugStandard therapy. Administered by instilling a solution into the bladder via a catheter. Dosage: 2000mg dissolved in 50mL normal saline per instillation. Regimen: One instillation immediately post-TURBT, followed by an induction phase (once weekly for 8 weeks) and a maintenance phase (once monthly for 10 months). The solution is retained for 30-60 minutes.
24-month Bladder Tumor Recurrence Rate
The proportion of patients with bladder tumor recurrence confirmed by cystoscopy and tissue biopsy within 24 months after transurethral resection of bladder tumor (TURBT). The recurrence rate is calculated as: (Number of patients with confirmed recurrence in the group / Total number of analyzed patients in that group) × 100%.
Proportion of Pathological Grade Upgrading upon Recurrence
The proportion of patients with recurrent tumor whose pathological grade (e.g., from low-grade to high-grade) is worse than at initial diagnosis among all patients with recurrence.
Tumor Complete Response (CR) Rate
The proportion of patients with no evidence of tumor recurrence, metastasis, or progression as confirmed by regular cystoscopy, biopsy, urinary cytology, and imaging.
Incidence of Bladder Irritation Symptoms and Gross Hematuria
Record and compare the proportion of patients in both groups experiencing bladder irritation symptoms (e.g., frequency, urgency, dysuria) and gross hematuria post-operation.
Change in Quality of Life Core Questionnaire (QLQ-C30) Score
Assessed using the EORTC QLQ-C30 questionnaire. It includes 5 functional scales, 3 symptom scales, and a global health status item. The change from baseline in scores will be used to evaluate the change in quality of life.
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