Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

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

Treatments: Procedure: CBI

Study type: Interventional

Funder types: Other

Identifiers

NCT03839472

CASE12818

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Continuous Bladder Irrigation (CBI)

Experimental group

Description:

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.

Treatment:

Procedure: CBI