Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07474519

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

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

40

Participants Needed

1

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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 started induction therapy
  • Able to remain in a lying down (supine) position for two hours with head supported on up to two pillows
  • Able to remain in a sitting position for two hours
  • Willing to wear a fitness tracker for at least five days during the study
  • Able to participate in remote video or telephone visits
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Received intravesical BCG within the past 1 year
  • Known inability to retain BCG medication in the bladder
  • History of urinary incontinence with a score of 3 or higher on the Overactive Bladder Survey for urgency, urgency incontinence, or incontinence
  • Refusal to wear a fitness tracker during a 24-hour baseline, during treatment, or for 2 hours after treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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