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An Assessment of Patient Position and Intravesical BCG Dwell Time

Status: Recruiting
Location: See location...
Intervention Type: Biological, Other, Behavioral, Procedure
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov