Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07474519

An Assessment of Patient Position and Intravesical BCG Dwell Time

Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-16

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether the position of a patient during intravesical bacillus Calmette Guerin (BCG) treatment affects how long the BCG medication stays in the bladder, called dwell time. This is important for treating intermediate and high risk non-muscle invasive bladder cancer (NMIBC). The study also explores the use of a fitness tracker to monitor patient activity and vital signs during treatment to better understand factors that may influence treatment retention and effectiveness. Participants receive standard BCG therapy once a week for three weeks, with different post-treatment positioning for each session. During the first treatment, patients follow usual instructions to hold the BCG in their bladder for two hours without activity restrictions. In the second treatment, patients lie down as long as possible for up to two hours while holding the BCG. The third treatment requires patients to remain sitting for up to two hours. Throughout the study, participants wear a Fitbit to track activity and vital signs. During the trial, participants will be monitored for how long they retain the BCG medication, compliance with activity instructions, and adherence to wearing the fitness tracker. Researchers will collect data through vital sign monitoring, patient surveys, and electronic health record reviews. The main outcome measured is the BCG dwell time up to two hours, assessed over five weeks. Participants will be discharged immediately after treatment, with no disease progression or unacceptable toxicity expected during the study period.

CONDITIONS

Brief Title

Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with intermediate or high risk non-muscle invasive bladder cancer 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
Not Eligible

You will not qualify if you...

  • 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 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Up to 3 weeks

Participants receive standard of care BCG therapy once a week with different positioning instructions for each of the first three treatments. They also wear a Fitbit activity tracker throughout the study.

3 weekly visits (in-person) for BCG treatments

Follow-up

Duration - Up to 5 weeks

Participants are monitored for compliance with study instructions, Fitbit tracking, and vitals up to 5 weeks after treatment begins.

Visits or remote assessments as needed during follow-up

Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

T

The Ohio State University Comprehensive Cancer Center

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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