NCT07474519 Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer
| NCT ID | NCT07474519 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Non-Muscle Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-26 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-02-26 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
The Ohio State University Comprehensive Cancer Center
✉ OSUCCCClinicaltrials@osumc.edu📞 800-293-5066
Cheryl T Lee, MD
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07474519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Muscle Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07474519 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07474519 currently recruiting?
Yes, NCT07474519 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT07474519 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07474519 clinical trial?
NCT07474519 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Cheryl T Lee, MD at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 40 participants.