Body position and bladder hold time during BCG treatment for non-muscle invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase IV study gives participants three weekly standard-of-care intravesical BCG treatments with different post-treatment positions: no activity restriction, lying down, and sitting, each held for up to two hours. Investigators measure BCG dwell time and use a Fitbit accelerometer to capture patient activity and vitals during a 24-hour baseline, treatment, and two hours post-treatment. The study enrolls patients with intermediate- or high-risk NMIBC who have not yet started induction BCG and compares dwell time across the three position conditions. The protocol also tests the feasibility of remote wearable monitoring to document mobility and retention during routine clinic-based BCG.

Why it matters

Who can join: the full rules

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

Where it's running

• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Cheryl T Lee, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 800-293-5066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)

  This study tests whether UGN-501 can be safely given into the bladder to treat adults with recurrent non-muscle invasive bladder cancer.

  Recruiting at 6 sites Phase 1 UroGen Pharma Ltd. · Queen Creek, Arizona and 14 other locations · NCT07725796

• TARA-002 vs chemotherapy for high-grade non-muscle invasive bladder cancer in adults not previously treated with BCG

  A phase 3 study tests whether TARA-002 can help adults with high-grade non-muscle invasive bladder cancer who haven’t had BCG, comparing it to standard intravesical chemotherapy.

  Recruiting at 11 sites Phase 3 Protara Therapeutics · Queen Creek, Arizona and 10 other locations · NCT07480356

• Cruciferous vegetable eating program to reduce recurrence and progression in early-stage bladder cancer

  This trial will test whether a behavioral program that increases cruciferous vegetable intake (like broccoli, cabbage, kale) and a maintenance component can lower recurrence or progression in adults with early-stage non-muscle invasive bladder cancer.

  Recruiting Phase 2 Roswell Park Cancer Institute · Buffalo, New York · NCT06733363

• In-home chemotherapy for bladder cancer treatment

  This study tests whether giving chemotherapy for bladder cancer at home is safe and more convenient for patients compared to getting it in a clinic.

  Recruiting Phase 1/2 Mayo Clinic · Jacksonville, Florida · NCT06704191

• Combining pembrolizumab with radiation therapy for bladder cancer treatment

  This study is testing if combining the immunotherapy drug pembrolizumab with radiation therapy can help people with non-muscle invasive bladder cancer do better than standard chemotherapy during treatment.

  Recruiting at 135 sites Phase 2 National Cancer Institute (NCI) · Tucson, Arizona and 146 other locations · NCT06770582

• Combining irinotecan liposomes and epirubicin for bladder cancer treatment after anthracyclines failure

  This study is testing a new treatment that combines two drugs, irinotecan liposomes and epirubicin, to see if it can help people with bladder cancer who didn't get better with previous therapy.

  Recruiting Phase 1 First Affiliated Hospital of Chongqing Medical University · Chongqing · NCT06766266

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.