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

NCT07279792 | Completed Phase 2

• 1 other identifier: FMASU MS 685/2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Risk of Recurrence

  6 months

• Risk of progression of bladder cancer

  6 months

Study Arms (3)

Continuous Bladder Irrigation with distilled water

ACTIVE COMPARATOR

Drug: Continuous Bladder Irrigation with distilled water

Continuous Bladder Irrigation with normal saline

ACTIVE COMPARATOR

Drug: Continuous Bladder Irrigation with normal saline

Continuous Bladder Irrigation with hypertonic saline

ACTIVE COMPARATOR

Drug: Continuous Bladder Irrigation with hypertonic saline

Interventions

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 normal saline

Continuous Bladder Irrigation with hypertonic saline DRUG

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

Continuous Bladder Irrigation with hypertonic saline

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 distilled water

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Saline Solution; Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hypertonic Solutions

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: October 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)