Clinical trial NCT03839472: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Official title: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)
Bladder Tumor (TURBT)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm where each patient will act as his/her own internal control (cell count before and after CBI).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in mean cells count before versus after liter 1 of CBI
timeFrame: Immediately after CBI procedure.
measure: Change in mean cells count before versus after liter 2 of CBI
timeFrame: Immediately after CBI procedure.
measure: Change in mean cells count before versus after liter 3 of CBI
timeFrame: Immediately after CBI procedure.
measure: Change in mean cells count before versus after liter 4 of CBI
timeFrame: Immediately after CBI procedure.
measure: Change in mean cells count before versus after liter 5 of CBI
timeFrame: Immediately after CBI procedure.
Secondary outcomes:
measure: Recurrence rate of patients who underwent CBI post TURBT.
timeFrame: 2 years after end of treatment
measure: Progression rate of patients who underwent CBI post TURBT.
timeFrame: 2 years after end of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lee Ponsky
role: PRINCIPAL_INVESTIGATOR
References: