A new clinical trial published on ClinicalTrials.gov is examining whether body position could influence how well one of the most widely used treatments for non-muscle invasive bladder cancer (NMIBC) works.
For the past four decades, intravesical bacillus Calmette-Guérin (BCG) therapy has been a cornerstone treatment designed to reduce progression and recurrence by stimulating the immune system directly inside the bladder.
A key aspect of BCG treatment is dwell time, or the length of time individuals are able to hold the medication in their bladder after it is administered. Standard guidance typically asks patients to avoid urinating for two hours following treatment, but this can be difficult for many people with NMIBC. Limited bladder capacity, mobility restrictions and severe urinary symptoms can make retaining the drug uncomfortable or impractical.
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While prior research suggests that longer dwell times may improve outcomes, little is known about whether patient positioning or activity can impact how long the medication is retained. The new trial aims to assess whether lying or sitting down could improve BCG dwell time and thereby help optimize the therapy.
Participants will receive standard-of-care BCG once a week for three weeks, with each session using a different set of post-treatment instructions. During the first treatment, patients will be discharged immediately and can move freely while attempting to retain the drug for up to two hours. During the second, they will remain lying down for as long as they can hold the medication and during the third, they will remain seated.
In addition to evaluating positioning, the study will explore the feasibility of using a fitness tracker to remotely capture patient vitals and mobility during treatment.
Eligible participants include adults aged 18 and older diagnosed with intermediate- or high-risk NMIBC who are scheduled to receive standard BCG therapy and have not experienced disease progression or unacceptable toxicity. Patients must be able to undergo intravesical treatment and wear the activity tracker throughout the study period. Those who have progressive disease, a history of urinary incontinence or conditions that would prevent safe participation are not eligible.
If successful, the study could lead to simple, low-cost changes in how BCG therapy is delivered, potentially improving tolerability and outcomes for those who struggle to retain the medication. Researchers expect the study to be completed by the end of next year.
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