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BRIEF TITLE: Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors


  • Org Study ID: CASE12818
  • Secondary ID:
  • NCT ID: NCT03839472
  • NCT Alias:
  • Sponsor: Case Comprehensive Cancer Center - Other
  • Source: 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: Immediately after CBI procedure.

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

Primary Outcome 2 - Time Frame: Immediately after CBI procedure.

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

Primary Outcome 3 - Time Frame: Immediately after CBI procedure.

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

Primary Outcome 4 - Time Frame: Immediately after CBI procedure.

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

Primary Outcome 5 - Time Frame: Immediately after CBI procedure.

Condition:

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

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
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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: Lee Ponsky

Phone: 1-800-641-2422

Email: CTUReferral@UHhospitals.org

Location

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