Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

NCT ID: NCT03839472

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continuous Bladder Irrigation (CBI)

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.

Group Type: EXPERIMENTAL

CBI

Intervention Type: PROCEDURE

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

Interventions

CBI

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Ponsky

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE12818

Identifier Type: -

Identifier Source: org_study_id