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RECRUITING
NCT07474519
PHASE4

Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This phase IV trial studies whether there is a relationship between how a patient is positioned while receiving bacillus Calmette Guerin (BCG) within the bladder (intravesical) and how long BCG stays in the bladder (dwell time) to improve the treatment of non-muscle invasive bladder cancer. For the past 40 years, intravesical BCG has been used for the treatment of non-muscle invasive bladder cancer. An important factor for BCG treatment is the dwell time, which is the period of time a patient can hold the BCG medication in the bladder after it has been given. Normally, patients are instructed during intravesical BCG treatment to avoid emptying the bladder for 2 hours after the BCG is given. However, this may be difficult for some patients who may have limited bladder capacity, restricted movement, or severe urinary symptoms. There have been studies outlining the relationship with increased dwell time and how well the treatment works, but studies on the potential impact of patient positioning or activity on the patient's ability to retain the drug are limited. Researchers hope by studying whether there is a relationship between patient positioning during intravesical BCG treatment and dwell time, they may be able to improve how BCG treatment for non-muscle invasive bladder cancer is given, especially for patients with limited bladder capacity, restricted movement, or severe urinary symptoms.

Official title: An Assessment of Patient Position and Intravesical BCG Dwell Time

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-02-26

Completion Date

2027-12-31

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

PROCEDURE

Accelerometry

Receive and wear Fitbit

BIOLOGICAL

BCG Solution

Given intravesically with no activity restrictions

BIOLOGICAL

BCG Solution

Given intravesically in lying down position

BIOLOGICAL

BCG Solution

Given intravesically in sitting position

OTHER

Electronic Health Record Review

Ancillary studies

BEHAVIORAL

Patient Discharge

Receive immediate clinic discharge

OTHER

Survey Administration

Ancillary studies

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States