Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
Status: | Not yet recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | March 2019 |
End Date: | December 30, 2021 |
Contact: | Lee Ponsky |
Email: | CTUReferral@UHhospitals.org |
Phone: | 1-800-641-2422 |
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.
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.
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.
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.
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
We found this trial at
1
site
Cleveland, Ohio 44106
Phone: 800-641-2422
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