Clinical trial · Interventional
Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors
NCT03839472CI-TRIAL-00058434withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Revision to improve cell recovery
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Tumor (TURBT) | Bladder Neoplasm | ALIAS | 0.85 |
| Non-muscle Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Continuous Bladder Irrigation (CBI)
- description
- Each subject will have a TURBT procedure performed per standard of care procedure, which will be followed by the study intervention - Continuous Bladder Irrigation (CBI) for up to two hours after procedure. Six samples of discarded bladder irrigation will be collected from each participant (N=20) immediately after TURBT and after the completion of each liter of normal saline 0.9% irrigation (1 to 5 L) for a total of 120 samples.
- interventionNames
- Procedure: CBI
Primary outcomes (5)
- measure
- Change in mean cells count before versus after liter 1 of CBI
- timeFrame
- Immediately after CBI procedure.
- description
- The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.
- measure
- Change in mean cells count before versus after liter 2 of CBI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.