The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT.

Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects.

Patients A total of 150 patients will be enrolled in this trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaplan Medical Center

Criteria

Inclusion Criteria:

• 1. Age ≥18 years, men and women who are scheduled for TURBT at our center 2. Newly diagnosed papillary bladder tumors < 3cm in largest diameter at cystoscopy 3. Normal upper tracts as determined by CTU/MRU either during the 1 year before TURBT of done within one month after TURBT 4. Serum creatinine level ≤ 2.5 mg / dl before inclusion

5. Serum sodium level <145 meq/ dl before inclusion

Exclusion Criteria:

• 1. Previous diagnosis of urothelial carcinoma 2. Solid tumors or larger than 3 cm in diameter 3. Any patient with concurrent upper tract TCC by either imaging or endoscopy

4. Patients with preoperative hypernatremia >145 meq/dl 5. Patients with preoperative renal failure serum creatinine level >2.5 mg / dl 6. Patients with indwelling double J stents or when such a stent is inserted during the TURBT

Abortion Criteria:

1. Resections that mandate CBI (continuous bladder irrigation)

2. Incomplete resections / endoscopic appearance of MIBC

3. Suspected bladder perforation