Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Case Comprehensive Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

CBIPROCEDURE

CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.