NCT07474519

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

An Assessment of Patient Position and Intravesical BCG Dwell Time

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the relationship between bacillus Calmette Guerin (BCG) dwell time and patient position in subjects with intermediate risk (IR) and high risk (HR) non-muscle-invasive bladder cancer (NMIBC). II. To assess the feasibility of a fitness tracker for remote capture of patient vitals and mobility during intravesical BCG treatment. OUTLINE: Patients receive standard of care (SOC) BCG therapy once a week (QW) and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity. FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge. SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours. THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours. Additionally, patients receive and wear a Fitbit activity tracker throughout the study.

Conditions

• Non-Muscle Invasive Bladder Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-26
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study