Studying Patient Position and BCG Dwell Time for Bladder Cancer
This study is looking at how different body positions affect how long Bacillus Calmette Guerin (BCG) stays in your bladder when treating non-muscle invasive bladder cancer. BCG is a common treatment, and how long it stays in your bladder (called "dwell time") is important. You would receive BCG solution three times, each time with different instructions: once with no activity restrictions, once lying down, and once sitting. Researchers will use a Fitbit to track your activity. The goal is to see if certain positions help the BCG work better. This study plans to enroll 40 participants aged 18 and older who have not yet started BCG treatment for intermediate or high-risk non-muscle invasive bladder cancer.
- Study design
- This interventional study plans to enroll 40 participants. It will compare the effects of different patient positions during BCG treatment.
- What's involved
- You will receive BCG solution three times, each with different positioning instructions. You will also wear a Fitbit activity tracker for at least five days during the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- BCG dwell time will be assessed up to 5 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer
At a glance
Conditions
NCT07474519
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ohio State University Comprehensive Cancer Center
Columbus, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Cheryl T Lee, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Bacillus Calmette Guerin (BCG) dwell timeFrom the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks
Will be measured on the same participant under three test positions (ad lib, supine, and seated). A generalize linear mixed model for correlated data will be used to compare the three test conditions. Dwell time will be modeled as a function of test condition and any other covariates (i.e. patient characteristics and/or environmental aspects) thought to be related to dwell time. Interaction effects with test condition will be considered. If a majority of participants (\> 75%; n = 10) have dwell times of 2 hours, the statistical method used to compare the 3 test conditions will be changed. To determine factors that impact the ability to maintain the BCG for two hour, a generalized estimating equation (GEE) model will be used. The outcome of interest will be a binomial indicator of dwell time equal to (coded as 1) or less than (coded as 0) 2 hours. Covariates will include all patient characteristics, and any environmental aspects suspected of influencing dwell time.