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OpenTrials
Completed

NCT Number: NCT07279792

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Bladder Irrigation with distilled water

Drug

Continuous Bladder Irrigation with distilled water post non muscle invasive bladder cancer urethral resection by endoscopy

Continuous Bladder Irrigation with normal saline

Drug

Continuous Bladder Irrigation with normal saline post non muscle invasive bladder cancer urethral resection by endoscopy

Continuous Bladder Irrigation with hypertonic saline

Drug

Continuous Bladder Irrigation with hypertonic saline post non muscle invasive bladder cancer urethral resection by endoscopy

Primary outcomes

  1. Risk of Recurrence

    Time frame: 6 months

  2. Risk of progression of bladder cancer

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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