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Brief Title: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

INTRODUCTION

  • Org Study ID: CASE12818
  • Secondary ID: N/A
  • NTC ID: NCT03839472
  • Sponsor: Case Comprehensive Cancer Center

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.


  • Overall Status
    Recruiting
  • Start Date
    September 1, 2019
  • Phase
    N/A
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Change in mean cells count before versus after liter 1 of CBI

Primary Outcome 1 - Timeframe: Immediately after CBI procedure.

Primary Outcome 2 - Measure: Change in mean cells count before versus after liter 2 of CBI

Primary Outcome 2 - Timeframe: Immediately after CBI procedure.

Primary Outcome 3 - Measure: Change in mean cells count before versus after liter 3 of CBI

Primary Outcome 3 - Timeframe: Immediately after CBI procedure.

Primary Outcome 4 - Measure: Change in mean cells count before versus after liter 4 of CBI

Primary Outcome 4 - Timeframe: Immediately after CBI procedure.

Primary Outcome 5 - Measure: Change in mean cells count before versus after liter 5 of CBI

Primary Outcome 5 - Timeframe: Immediately after CBI procedure.

CONDITION

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

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Lee Ponsky

Role: Principal Investigator

Affiliation: University Hospitals Cleveland Medical Center

Overall Contact

Name: Lee Ponsky

Phone: 1-800-641-2422

Email: CTUReferral@UHhospitals.org

LOCATION

Facility Status Contact
Facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact:
Lee Ponsky
800-641-2422
CTUReferral@UHhospitals.org