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

Official title

An Assessment of Patient Position and Intravesical BCG Dwell Time

Overview

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.

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

Primary outcome measures

• Bacillus Calmette Guerin (BCG) dwell time [Time frame: From the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks]

Secondary outcome measures (4)

• Probability of maintaining BCG for at least 1 hour [Time frame: From the instillation of the drug up to 1 hour, assessed up to 5 weeks]
• Compliance with study instructions [Time frame: Up to 5 weeks]
• Compliance to Fitbit tracking [Time frame: From appointment arrival until first void, assessed up to 5 weeks]
• Fitbit and clinician obtained vitals [Time frame: Up to 5 weeks]

Eligibility criteria

Inclusion criteria

• Patient with intermediate or high risk NMIBC opting for intravesical induction BCG
• Has not initiated induction therapy
• Able to remain in supine position for two hours. (Head may be raised on up to two pillows)
• Able to remain in a sitting position for two hours
• Willingness to utilize a wearable fitness tracker for at least five days during the study
• Able to perform a remote video or telephone encounter
• Able to provide informed consent

Exclusion criteria

• Receipt of intravesical BCG within the past 1 year
• Known inability to retain BCG
• History of urinary incontinence with a score of 3 or more on the Overactive Bladder Survey (OAB) urgency, urgency incontinence, or incontinence questions
• Refusal to wear a fitness tracker during a 24-hour baseline, during treatment, and/or for 2 hours post treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07474519 · OSU-25063 · NCI-2026-01296

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗