Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Non-muscle Invasive Bladder Cancer (NMIBC) Clinical Trial

Official title:

Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03839472
• Other study ID #: CASE12818
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Tumor (TURBT)
• Non-muscle Invasive Bladder Cancer (NMIBC)
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	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