Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder Tumor Resection

Study Overview
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Brief Summary
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Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.

Official Title
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Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder

Conditions
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TCC

Intervention / Treatment
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* Drug: Hypertonic Saline 3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of 18 years or older able to sign informed consent A previous diagnosis of low grade bladder cancer A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion Serum creatinine levels ≤ 2.0 mg/dl Serum sodium levels <146 mg/ml Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months Patient is candidate for TURBT Exclusion Criteria: Previous history of high grade bladder cancer including carcinoma in situ Presence of upper urinary tract tumor on imaging Renal failure with serum creatinine >2.0 mg/dl prior to inclusion Hypernatremia >146 mg/dl prior to inclusion Contra-indication to undergo TURBT

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with low grade TCC<br>Patients of 18 years or older able to sign informed consent A previous diagnosis of low grade bladder cancer A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion Serum creatinine levels ≤ 2.0 mg/dl Serum sodium levels <146 mg/ml Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months Patient is candidate for TURBT | Drug: Hypertonic Saline 3%<br>* 3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo. | The investigators monitored the Sodium levels in the blood after the administration of the Hypertonic Saline and documented and measure side effects by Clavien-Dindo scale | 12 month |