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

NCT ID: NCT07279792

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-09-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Continuous Bladder Irrigation with distilled water

Group Type ACTIVE_COMPARATOR

Continuous Bladder Irrigation with distilled water

Intervention Type DRUG

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

Continuous Bladder Irrigation with normal saline

Group Type ACTIVE_COMPARATOR

Continuous Bladder Irrigation with normal saline

Intervention Type DRUG

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

Continuous Bladder Irrigation with hypertonic saline

Group Type ACTIVE_COMPARATOR

Continuous Bladder Irrigation with hypertonic saline

Intervention Type DRUG

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

Interventions

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Continuous Bladder Irrigation with distilled water

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

Intervention Type DRUG

Continuous Bladder Irrigation with normal saline

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

Intervention Type DRUG

Continuous Bladder Irrigation with hypertonic saline

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MS 685/2024

Identifier Type: -

Identifier Source: org_study_id

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