Clinical trial · Interventional
Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer
An Assessment of Patient Position and Intravesical BCG Dwell Time
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Muscle Invasive Bladder Carcinoma | Non-Muscle Invasive Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerometry | Procedure | — | UNRESOLVED |
| BCG Solution | Biological | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Patient Discharge | Behavioral | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (BCG no restrictions, BCG lying down, BCG sitting)
- description
- 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.
- interventionNames
- Procedure: Accelerometry
- Biological: BCG Solution
- Other: Electronic Health Record Review
- Behavioral: Patient Discharge
- Other: Survey Administration
Primary outcomes (1)
- measure
- Bacillus Calmette Guerin (BCG) dwell time
- timeFrame
- From the instillation of the drug to the void time or 2 hours, whichever is earlier, assessed up to 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available