Continuous Bladder Irrigation Following Transurethral Resection of Bladder Tumors

NCT03839472 | Withdrawn DMC

• 1 other identifier: CASE12818
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change in mean cells count before versus after liter 1 of CBI

  The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.

  Immediately after CBI procedure.

• Change in mean cells count before versus after liter 2 of CBI

  The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.

  Immediately after CBI procedure.

• Change in mean cells count before versus after liter 3 of CBI

  The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.

  Immediately after CBI procedure.

• Change in mean cells count before versus after liter 4 of CBI

  The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.

  Immediately after CBI procedure.

• Change in mean cells count before versus after liter 5 of CBI

  The mean cell count obtained before CBI will be compared to the mean cell counts obtained after each liter (5L total) of CBI.

  Immediately after CBI procedure.

Secondary Outcomes (2)

• Recurrence rate of patients who underwent CBI post TURBT.

  2 years after end of treatment

• Progression rate of patients who underwent CBI post TURBT.

  2 years after end of treatment

Study Arms (1)

Continuous Bladder Irrigation (CBI)

EXPERIMENTAL

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.

Procedure: CBI

Interventions

CBI PROCEDURE

CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.

Continuous Bladder Irrigation (CBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years and older diagnosed with a bladder mass on cystoscopy or imaging study
• Primary bladder tumor occurrence

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Lee Ponsky

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm where each patient will act as his/her own internal control (cell count before and after CBI).

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis.

Locations

US (1)