Implications of Post-Operative Irrigation Fluid's Osmolarity on the Recurrence of Non-Muscle Invasive Bladder Cancer Following Transurethral Resection

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Normal Saline; Hypertonic Saline; Nonmuscle Invasive Bladder Cancer; Irrigation; Bladder (Urothelial, Transitional Cell) Cancer; Distilled Water

Treatments: Drug: Continuous Bladder Irrigation with normal saline; Drug: Continuous Bladder Irrigation with distilled water; Drug: Continuous Bladder Irrigation with hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07279792

FMASU MS 685/2024

Details and patient eligibility

About

This randomized controlled trial will evaluate the efficacy of three bladder irrigation solutions - distilled water (DW), normal saline (NS), and hypertonic saline (HS) - as continuous bladder irrigation (CBI) following transurethral resection of non-muscle invasive bladder cancer (NMIBC). Short term (6 months) recurrence and progression free survival are mainly evaluated.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of non-muscle invasive urinary bladder urothelial carcinoma amenable for complete resection

Exclusion criteria

• Patients with post-operative complications that need prolonged irrigation.
• Patient who underwent incomplete resection during TURBT.
• When large bladder perforation was suspected during TURBT.
• Patients with chronic kidney disease.
• Muscle invasive disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Continuous Bladder Irrigation with distilled water

Active Comparator group

Treatment:

Drug: Continuous Bladder Irrigation with distilled water

Continuous Bladder Irrigation with normal saline

Active Comparator group

Treatment:

Drug: Continuous Bladder Irrigation with normal saline

Continuous Bladder Irrigation with hypertonic saline

Active Comparator group

Treatment:

Drug: Continuous Bladder Irrigation with hypertonic saline