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Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBI
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-muscle Invasive Bladder Cancer (NMIBC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous Bladder Irrigation (CBI)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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
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

Full Information

First Posted
February 8, 2019
Last Updated
May 10, 2022
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03839472
Brief Title
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Official Title
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Revision to improve cell recovery
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-muscle Invasive Bladder Cancer (NMIBC), Bladder Tumor (TURBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Bladder Irrigation (CBI)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
CBI
Intervention Description
CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.
Primary Outcome Measure Information:
Title
Change in mean cells count before versus after liter 1 of CBI
Description
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Time Frame
Immediately after CBI procedure.
Title
Change in mean cells count before versus after liter 2 of CBI
Description
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Time Frame
Immediately after CBI procedure.
Title
Change in mean cells count before versus after liter 3 of CBI
Description
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Time Frame
Immediately after CBI procedure.
Title
Change in mean cells count before versus after liter 4 of CBI
Description
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Time Frame
Immediately after CBI procedure.
Title
Change in mean cells count before versus after liter 5 of CBI
Description
The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
Time Frame
Immediately after CBI procedure.
Secondary Outcome Measure Information:
Title
Recurrence rate of patients who underwent CBI post TURBT.
Description
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
Time Frame
2 years after end of treatment
Title
Progression rate of patients who underwent CBI post TURBT.
Description
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
Time Frame
2 years after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Ponsky
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

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