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

NCT07474519 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: OSU-25063NCI-2026-01296
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bacillus Calmette Guerin (BCG) dwell time

  Will be measured on the same participant under three test positions (ad lib, supine, and seated). A generalize linear mixed model for correlated data will be used to compare the three test conditions. Dwell time will be modeled as a function of test condition and any other covariates (i.e. patient characteristics and/or environmental aspects) thought to be related to dwell time. Interaction effects with test condition will be considered. If a majority of participants (\> 75%; n = 10) have dwell times of 2 hours, the statistical method used to compare the 3 test conditions will be changed. To determine factors that impact the ability to maintain the BCG for two hour, a generalized estimating equation (GEE) model will be used. The outcome of interest will be a binomial indicator of dwell time equal to (coded as 1) or less than (coded as 0) 2 hours. Covariates will include all patient characteristics, and any environmental aspects suspected of influencing dwell time.

  From the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks

Secondary Outcomes (4)

• Probability of maintaining BCG for at least 1 hour

  From the instillation of the drug up to 1 hour, assessed up to 5 weeks

• Compliance with study instructions

  Up to 5 weeks

• Compliance to Fitbit tracking

  From appointment arrival until first void, assessed up to 5 weeks

• Fitbit and clinician obtained vitals

  Up to 5 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Accelerometry; Biological: BCG Solution; Other: Electronic Health Record Review; Behavioral: Patient Discharge; Other: Survey Administration

Interventions

BCG Solution BIOLOGICAL

Given intravesically with no activity restrictions

Also known as: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution

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

Electronic Health Record Review OTHER

Ancillary studies

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

Accelerometry PROCEDURE

Receive and wear Fitbit

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

Patient Discharge BEHAVIORAL

Receive immediate clinic discharge

Also known as: Discharge, Discharge from Healthcare Facility, Release

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

Survey Administration OTHER

Ancillary studies

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Interventions

Accelerometry; Patient Discharge; Drainage

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Continuity of Patient Care; Patient Care; Therapeutics; Hospitalization; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Surgical Procedures, Operative

Study Officials

• Cheryl T Lee, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)