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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07474519
Phase
PHASE4
Status
Recruiting
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Conditions

  • Non-Muscle Invasive Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Accelerometry — PROCEDURE
    Receive and wear Fitbit
  • BCG Solution — BIOLOGICAL
    Given intravesically with no activity restrictions
  • BCG Solution — BIOLOGICAL
    Given intravesically in lying down position
  • BCG Solution — BIOLOGICAL
    Given intravesically in sitting position
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Patient Discharge — BEHAVIORAL
    Receive immediate clinic discharge
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Feb 26, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Cheryl T. Lee, MD
[email protected]
614-685-4713
Cheryl T. Lee, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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