Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

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.

Study Overview

• Status: Withdrawn
• Conditions: Non-muscle Invasive Bladder Cancer (NMIBC); Bladder Tumor (TURBT)
• Intervention / Treatment: Procedure: CBI

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Lee Ponsky, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: CASE12818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No