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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
  • NCT 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
    Withdrawn
  • Start Date
    September 1, 2019
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Lee Ponsky

Role: Principal Investigator

Affiliation: University Hospitals Cleveland Medical Center

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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