NCT07474519 · Ohio State University Comprehensive Cancer Center
Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer
What this study is about
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.
View original scientific description
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 16, 2026 · Source of record for eligibility and locations