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NCT07474519RecruitingPhase 4

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 · Last updated 16 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
40 (estimated)
First submitted
11 Mar 2026
Start date
26 Feb 2026
Primary completion date
31 Dec 2027
Lead sponsor
Ohio State University Comprehensive Cancer Center
NCT number
NCT07474519

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 40
  • From 26 Feb 2026 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of urinary incontinence with a score of 3 or more on the Overactive Bladder Survey (OAB) urgency, urgency incontinence, or incontinence questions

Other

  • Receipt of intravesical BCG within the past 1 year
  • Known inability to retain BCG
  • Refusal to wear a fitness tracker during a 24-hour baseline, during treatment, and/or for 2 hours post treatment

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohio State University Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.