Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Study Overview
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Brief Summary
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The purpose of this pilot study is to determine if washing out the bladder with large volumes of saline after surgical removal of bladder tumors helps to decrease the number of loose cells floating within the bladder after surgery. Anticipated decrease in tumor recurrence and/or progression rates will be measured.

Detailed Description
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Bladder tumor recurrence after resection of non-muscle invasive bladder cancer (NMIBC) occurs in 50-70% of patients despite the use of adjuvant anticancer therapy after surgery. This is a single-arm, non-randomized pilot study looking to determine whether post-Transurethral Resection of Bladder Tumor (TURBT) cells counts differ significantly between continuous washout of the bladder (CBI) with normal saline compared to pre-CBI wash out. Anticipated decrease in tumor recurrence and/or progression rates will also be measured, and each participant will act as their own internal control.

Official Title
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Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Conditions
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Non-muscle Invasive Bladder Cancer (NMIBC), Bladder Tumor (TURBT)

Intervention / Treatment
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* Procedure: CBI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study Primary bladder tumor occurrence Exclusion Criteria: Patients with unresectable bladder tumors, as determined at the time of diagnosis or TURBT , or imaging concerning of T2 or higher disease Patients with bladder perforation at the time of TURBT, which is a contraindication to CBI Patients from vulnerable populations, including but not limited to impaired subjects, pregnant women, prisoners, family members of the study team Any previous history of bladder tumor resection or intravesical chemotherapy/immunotherapy History of previous pelvic radiation Bladder tumor volume > 5 cm, involvement of prostatic urethra, or any evidence of hydronephrosis on imaging

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
Interventional Model Description: Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Bladder Irrigation (CBI)<br>Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure. Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples. | Procedure: CBI<br>* CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean cells count before versus after liter 1 of CBI | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. | Immediately after CBI procedure. | 
| Change in mean cells count before versus after liter 2 of CBI | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. | Immediately after CBI procedure. | 
| Change in mean cells count before versus after liter 3 of CBI | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. | Immediately after CBI procedure. | 
| Change in mean cells count before versus after liter 4 of CBI | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. | Immediately after CBI procedure. | 
| Change in mean cells count before versus after liter 5 of CBI | The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI. | Immediately after CBI procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate of patients who underwent CBI post TURBT. | Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates. Recurrence is defined as the identification of a recurrent tumor of same grade and or stage or lower | 2 years after end of treatment | 
| Progression rate of patients who underwent CBI post TURBT. | Participants are followed for additional 2 years during which time, they will receive standard of care. Data collected during their 2-year follow up includes monitoring for recurrence and progression rates. Progression is defined as a recurrent tumor of higher grade and or stage | 2 years after end of treatment |