Non-Muscle Invasive Bladder CarcinomaPhase 4NCT07474519
Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer
A Phase 4 study testing Accelerometry, BCG Solution and Electronic Health Record Review in people with Non-Muscle Invasive Bladder Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Carcinoma
- What is being tested?
- Accelerometry, BCG Solution and Electronic Health Record Review
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Cheryl T. Lee, MD, 614-685-4713, cheryl.lee@osumc.edu
Cheryl T. Lee, MD
About this study
Official title: An Assessment of Patient Position and Intravesical BCG Dwell Time
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the relationship between bacillus Calmette Guerin (BCG) dwell time and patient position in subjects with intermediate risk (IR) and high risk (HR) non-muscle-invasive bladder cancer (NMIBC).
II. To assess the feasibility of a fitness tracker for remote capture of patient vitals and mobility during intravesical BCG treatment.
OUTLINE:
Patients receive standard of care (SOC) BCG therapy once a week (QW) and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity.
FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge.
SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours.
THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours.
Additionally, patients receive and wear a Fitbit activity tracker throughout the study.
- Conditions
- Non-Muscle Invasive Bladder Carcinoma
- Being tested
- Accelerometry, BCG Solution, Electronic Health Record Review, Patient Discharge, Survey Administration
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometryProcedure or surgery
Receive and wear Fitbit
BCG SolutionBiological
Also called Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Given intravesically with no activity restrictions
BCG SolutionBiological
Also called Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Given intravesically in lying down position
BCG SolutionBiological
Also called Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Given intravesically in sitting position
Electronic Health Record ReviewOther
Ancillary studies
Patient DischargeBehavioural
Also called Discharge, Discharge from Healthcare Facility, Release
Receive immediate clinic discharge
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (BCG no restrictions, BCG lying down, BCG sitting) | Experimental | Patients receive SOC BCG therapy QW and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity.
FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge.
SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours.
THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours.
Additionally, patients receive and wear a Fitbit activity tracker throughout the study. Receives: Procedure: Accelerometry; Biological: BCG Solution; Other: Electronic Health Record Review; Behavioral: Patient Discharge; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacillus Calmette Guerin (BCG) dwell time
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.
Measured: From the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks
Secondary outcomes (4)
Probability of maintaining BCG for at least 1 hour
The probability of maintaining the BCG for at least 1 hour for each test position will be compared using a GEE model. Any patient or environmental characteristics felt to impact on dwell time will be included as covariates in the GEE model.
Measured: From the instillation of the drug up to 1 hour, assessed up to 5 weeks
Compliance with study instructions
Compliance with study instructions (supine and seated positions only) will be measured using the Fitbit's count of number of steps taken and nursing staff observation. Compliance will be defined as zero or > zero steps (i.e. a binomial variable) during the test session. A GEE model will be constructed to compare each positions probability of remaining compliant.
Measured: Up to 5 weeks
Compliance to Fitbit tracking
Compliance to Fitbit tracking will be characterized as the time worn from appointment arrival until first void. Distribution of this variable is likely to be correlated with dwell time thus a GEE model will be used. Any patient or environmental characteristics felt to impact Fitbit tracking compliance will be included as covariates in the GEE model.
Measured: From appointment arrival until first void, assessed up to 5 weeks
Fitbit and clinician obtained vitals
The difference between Fitbit and clinician (i.e. the bias) will be computed and compared to zero (i.e. no difference between methods). Additionally, the difference (y-axis) will be plotted as a function of clinician determined vital sign (x-axis). Bland and Altmann suggest using the gold standard (clinician determined values of vital signs) on the horizontal axis when comparing new methods to a commonly used technique. In the absence of any pattern in the plot, the 95% limits of agreement will be calculated. This interval describes the range of expected differences in 95% of patients, thus, describing the potential accuracy of the Fitbit. The mean absolute percent error for both step count and heart rate will be calculated so that the results may be compared to those reported in other medical journals.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start26 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Lee, Ohio State University Comprehensive Cancer Center
- Investigators
- Cheryl T Lee, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474519
- Sponsor's protocol ID
- OSU-25063
- Other IDs
- NCI-2026-01296
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Patient Position and Intravesical BCG Dwell Time
- ClinicalTrials.gov ID
- NCT07474519
- Acronym / sponsor ID
- OSU-25063
- Conditions
- Non-Muscle Invasive Bladder Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To assess the relationship between bacillus Calmette Guerin (BCG) dwell time and patient position in subjects with intermediate risk (IR) and high risk (HR) non-muscle-invasive bladder cancer (NMIBC).
II. To assess the feasibility of a fitness tracker for remote capture of patient vitals and mobility during intravesical BCG treatment.
OUTLINE:
Patients receive standard of care (SOC) BCG therapy once a week (QW) and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity.
FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge.
SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours.
THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours.
Additionally, patients receive and wear a Fitbit activity tracker throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (BCG no restrictions, BCG lying down, BCG sitting) | Experimental | Procedure: Accelerometry, Biological: BCG Solution, Other: Electronic Health Record Review, Behavioral: Patient Discharge, Other: Survey AdministrationPatients receive SOC BCG therapy QW and post-treatment activity guidance for the first three weekly BCG installations in the absence of disease progression or unacceptable toxicity. FIRST TREATMENT: Patients receive SOC BCG intravesically and instructions to avoid urination for two hours with no activity restrictions and immediate clinic discharge. SECOND TREATMENT: Patients receive SOC BCG intravesically and remain in a lying down position for as long as able to hold treatment in for up to 2 hours. THIRD TREATMENT: Patients receive SOC BCG intravesically and remain in a sitting position for as long as able to hold treatment in for up to 2 hours. Additionally, patients receive and wear a Fitbit activity tracker throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometryReceive and wear Fitbit | Procedure or surgery | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| BCG SolutionAlso: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG SolutionGiven intravesically with no activity restrictions | Biological | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| BCG SolutionAlso: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG SolutionGiven intravesically in lying down position | Biological | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| BCG SolutionAlso: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG SolutionGiven intravesically in sitting position | Biological | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| Patient DischargeAlso: Discharge, Discharge from Healthcare Facility, ReleaseReceive immediate clinic discharge | Behavioural | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
| Survey AdministrationAncillary studies | Other | Treatment (BCG no restrictions, BCG lying down, BCG sitting) |
Primary outcome
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.
4 secondary outcomes
Probability of maintaining BCG for at least 1 hour
Time frame: From the instillation of the drug up to 1 hour, assessed up to 5 weeks
Compliance with study instructions
Time frame: Up to 5 weeks
Compliance to Fitbit tracking
Time frame: From appointment arrival until first void, assessed up to 5 weeks
Fitbit and clinician obtained vitals
Time frame: Up to 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Cheryl T Lee, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Accelerometry, BCG Solution and Electronic Health Record Review in people with Non-Muscle Invasive Bladder Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.