AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Evaluation of safety of somatic cell based therapy for urinary incontinence in patients after radical prostatectomy, open trial.

This is an early-stage research study, often called a Phase 1 trial. It's designed to see if a new treatment is safe for men who experience urinary incontinence, which is leakage of urine, after having surgery for prostate cancer (a radical prostatectomy). The treatment involves using special body cells (somatic cell-based therapy) that are hoped to improve bladder control. Researchers want to make sure this new treatment doesn't cause serious side effects and how it acts in the human body. This is the very first time this specific cell treatment is being given to people, so understanding its safety is the main goal.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Nicolaus Copernicus University

Enrolment target

Start

31 Oct 2024

urinary incontinence

What is this study about?

Imagine your body has tiny building blocks called cells. Sometimes, after prostate surgery for cancer, the muscles that control when you wee can get weaker, leading to accidental leaks. This is called urinary incontinence.

This study is testing a new idea to help with this. It involves using special cells from the body itself, and putting them where they might help strengthen those muscles again. Because this is the first time this specific cell treatment is being used in people, the main focus is on making sure it's safe and doesn't cause harm. It's like gently testing the waters with a brand new way of helping.

The information gathered from this study will help doctors understand more about how this cell treatment works and if it could be a promising step towards better ways of managing urinary incontinence after prostate surgery in the future. It's an important early step in developing new therapies.

Key takeaways

This is an early-stage study focusing on the safety of a new cell treatment.
It's for men who leak urine after prostate surgery.
The main goal is to see if the cell treatment is safe and what effects it has.
Participation helps future research, but a cure is not guaranteed.
You have the right to leave the study at any time.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older. The study is specifically for men who have had a type of surgery called a radical prostatectomy, which is an operation to remove the prostate gland, and are now experiencing urinary incontinence (leaking urine).

There might be other health conditions or medications that would prevent someone from joining, even if they meet the age and sex requirements. These details would be discussed fully with the study team.

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.

Are you a man?
Are you 18 years old or older?
Have you had a full prostate removal (radical prostatectomy)?
Are you currently experiencing urinary incontinence (leaking urine)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study team will explain everything thoroughly. You would likely have several visits to the clinic for check-ups, to receive the cell treatment, and to see how you are doing afterwards. These visits will probably include physical examinations, blood tests, and special questionnaires or tests to check your bladder control. The total length of your involvement in the study would be explained before you decide to join.

Potential risks and benefits

Because this is a very early study (Phase 1), the main goal is to find out if the treatment is safe. There might not be a direct benefit to your urinary incontinence from taking part, but you would be helping researchers learn valuable information that could help others in the future. As with any new treatment, there could be side effects or risks that no one fully understands yet. These would be explained in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Poland

Common questions

What is 'urinary incontinence'?

It means accidentally leaking urine, which can happen after prostate gland surgery.

What are 'somatic cells'?

These are special cells taken from your own body that could help repair or strengthen tissues.

Why is this called an 'open trial'?

It means both you and the study doctors will know that you are receiving the active cell treatment.

Will this treatment definitely cure my incontinence?

This early study is mainly about safety, not cure. Any benefits to your incontinence are a secondary aim at this stage.

How long will I be in the study?

The exact duration will be explained by the study team, as it varies depending on the trial design and follow-up needed.