Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations.
The study will include patients from Denmark, Iceland, Norway and Sweden.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥18 years of age at the time of signing the Informed Consent Form
* Signed Informed Consent Form
* Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
* Ta high grade without CIS
* CIS with or without previous or concomitant Ta tumors
* T1 with or without CIS
* Is, according to the Investigator's judgement, able to comply with the trial protocol
* Ability to understand the Patient Information Sheet orally and in writing
Exclusion Criteria:
* Previous BCG instillations within the last 2 years, because of the risk of not having cleared potential previos side effects.
* T1 tumors where re-resection had not been performed
* TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
* Previous or current MIBC
* Progression defined as progrssion to T1-tumour, T2+\_tumour or cystectomy irrespectievely of indication or development of metastatic urothelial cancer irrespectively of tumour stage
* Contraindications to BCG
* Incontinence
* Bilateral nephrostomy catheters; unilateral nephrostomy catheter is allowed if permanent for the duration of all inistallations with BCG and a normally functioning kidney.
* Need for catheter a demeure at the time of instillation
* Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
* Reduced immune response (leukaemia, lymphoma)
* Kno…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.