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

RecruitingPhase 4Ages 18 Years - anyAllOhio State University Comprehensive Cancer Center
NCT07474519 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 increas

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📋 Eligibility rules (as published)
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
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What it tests

  • Accelerometry
  • BCG Solution
  • BCG Solution
  • BCG Solution
  • Electronic Health Record Review
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Where

1 site
Ohio State University Comprehensive Cancer Center
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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