Body position and bladder hold time during BCG treatment for non-muscle invasive bladder cancer
An Assessment of Patient Position and Intravesical BCG Dwell Time
PHASE4 · Ohio State University Comprehensive Cancer Center · NCT07474519
This project will test whether lying down or sitting during BCG treatment changes how long the medicine stays in the bladder for people with intermediate- or high-risk non-muscle invasive bladder cancer.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT07474519 on ClinicalTrials.gov |
What this trial studies
This Phase IV study gives participants three weekly standard-of-care intravesical BCG treatments with different post-treatment positions: no activity restriction, lying down, and sitting, each held for up to two hours. Investigators measure BCG dwell time and use a Fitbit accelerometer to capture patient activity and vitals during a 24-hour baseline, treatment, and two hours post-treatment. The study enrolls patients with intermediate- or high-risk NMIBC who have not yet started induction BCG and compares dwell time across the three position conditions. The protocol also tests the feasibility of remote wearable monitoring to document mobility and retention during routine clinic-based BCG.
Who should consider this trial
Good fit: People with intermediate- or high-risk non-muscle invasive bladder cancer who have not started induction BCG, can remain supine and sitting for up to two hours, and are willing to wear a fitness tracker are ideal candidates.
Not a fit: Patients who cannot retain BCG, have significant urinary incontinence, received intravesical BCG within the past year, or are unwilling/unable to wear the fitness tracker or attend the study center are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could lead to simple, low-cost position recommendations that increase BCG dwell time and potentially improve treatment effectiveness without adding medications.
How similar studies have performed: Prior research links longer BCG dwell time to better outcomes, but deliberately changing patient position to alter dwell time and using wearables for monitoring is largely novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Cheryl T Lee, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non-Muscle Invasive Bladder Carcinoma