A follow-up extension study of patients who completed the U-LaserPrint-1 clinical trial to evaluate the long-term safety and efficacy of treatment with InvivoLPrint-U.
This research study is an extension study for people who previously took part in an earlier trial called U-LaserPrint-1. It is for adults who had their bladder removed to treat advanced bladder cancer and received a newly engineered replacement bladder made with a treatment called aUroCell-Tx. Doctors want to follow participants over a longer period to see how safe and effective the replacement bladder remains over time. They will check whether the body accepts the new bladder, track any surgical complications or urinary infections, and see how well patients can control their urine. The team will also monitor general health and blood balance, and ask patients to fill out questionnaires about their day-to-day quality of life. The findings will help doctors learn whether this new technology is a safe, helpful option for future bladder cancer patients.
At a glance
What is this study about?
Bladder cancer can sometimes grow deep into the muscle wall of the bladder. When this happens, doctors often need to remove the whole bladder to stop the cancer from spreading. After this major surgery, patients need a new way to collect and pass urine. In the earlier part of this study, surgeons created a replacement bladder using a new bio-printed tissue approach known as aUroCell-Tx.
This follow-up study is designed to watch over those patients for a longer period. Because this treatment is one of the first of its kind used in humans, it is vital to know what happens months and years after surgery. The research team wants to ensure the new bladder continues to work well and does not cause unexpected health issues down the line.
During the study, doctors will look closely at whether the body accepts the new bladder or shows signs of rejecting it. They will also keep track of common urinary problems, such as infections, kidney stones, leaking, and changes in the body's natural chemical balance. Patients will also share how they feel day to day through simple health surveys.
By taking part, participants help scientists gather vital answers about how modern tissue-engineering works in real life. This knowledge will guide future surgical options, aiming to give people with bladder cancer safer recoveries and a better quality of life.
Key takeaways
- Long-term follow-up study for adults who completed the U-LaserPrint-1 trial.
- Monitors the safety and function of a newly engineered replacement bladder.
- Checks for urinary infections, stone formation, leaks, and rejection signs.
- Includes quality-of-life surveys to understand day-to-day well-being.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is only open to adults aged 18 and older who have already taken part in the earlier U-LaserPrint-1 clinical trial. Patients must have had surgery to remove their bladder because of muscle-invasive bladder cancer and received the experimental replacement bladder.
Both men and women can join. If you did not participate in the first trial, you will not be able to join this follow-up study. Your hospital care team can confirm whether your previous treatment makes you eligible.
You will also need to be able to attend follow-up visits and complete routine tests and health questionnaires so the team can monitor your recovery safely.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have had surgery to remove my bladder due to muscle-invasive bladder cancer.
- I previously took part in and completed the U-LaserPrint-1 clinical trial.
- I received the aUroCell-Tx replacement bladder.
- I am able and willing to attend follow-up hospital visits for tests and surveys.
What does participation involve?
Taking part in this study involves attending regular hospital check-ups with the research team. Because this is a follow-up extension study, you will not need to receive a new surgical treatment. Instead, the focus is on tracking your health and checking how your replacement bladder is doing over time.
During clinic visits, doctors will examine you and run standard medical checks. These usually include urine and blood tests to look for infections, kidney function, and chemical balance. The team may also carry out scans to check for urinary stones or other changes around the bladder area.
You will be asked about your day-to-day bladder control, such as whether you experience any leaks, and you will complete short questionnaires about your physical and emotional well-being. Your doctor will discuss the exact visit schedule and overall duration of follow-up before you agree to continue.
Potential risks and benefits
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Common questions
Will I need to have another major operation to take part?
No, this study is designed to monitor your health following your previous surgery, although corrective treatment will be provided if any problems arise.
Can anyone with bladder cancer join this study?
No, this study is only open to patients who already took part in the earlier U-LaserPrint-1 trial and received the study's replacement bladder.
What kind of tests will I have during the visits?
Visits usually involve routine blood and urine tests, physical check-ups, occasional scans, and filling out forms about how you feel.
Will I have to pay for any study appointments?
No, taking part in a clinical trial does not cost you anything, and your hospital team can advise if travel costs can be reimbursed.
What happens if I decide I no longer want to take part?
You can leave the study at any time. Your normal medical care and relationship with your doctors will stay exactly the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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