Recruiting

BCG

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07474519

Conditions

Non-Muscle Invasive Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Accelerometry

BCG Solution

BCG Solution

BCG Solution

Electronic Health Record Review

Study Details

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.

Conditions

Non-Muscle Invasive Bladder Carcinoma

Study ID

NCT07474519

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (BCG no restrictions, BCG lying down, BCG sitting)

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.

Interventions

Accelerometry

Receive and wear Fitbit

BCG Solution

Given intravesically with no activity restrictions

BCG Solution

Given intravesically in lying down position

BCG Solution

Given intravesically in sitting position

Electronic Health Record Review

Ancillary studies

Patient Discharge

Receive immediate clinic discharge

Survey Administration

Ancillary studies

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 ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Cheryl T. Lee, MD

614-685-4713cheryl.lee@osumc.edu

Principal Investigator:

Cheryl T. Lee, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-03-16.