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Not yet recruitingNAINTERVENTIONAL

A Reminder App to Optimize Bladder Filling in Patients with Prostate Cancer Receiving HYPO-fractionated Radiotherapy

This study is for men with prostate cancer who are having a specific type of radiotherapy called hypofractionated radiotherapy. The main aim is to see if a special reminder app can help them drink enough water before each treatment session. Having a reasonably full bladder during radiotherapy is important because it can help protect other organs and reduce side effects like bladder irritation. We want to find out if using this app helps patients keep their bladder volume above 200 ml more often. The study will compare how often the bladder is too empty in people using the app versus what we've seen in similar patients in the past who didn't use an app.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
University Hospital Schleswig-Holstein
Enrolment target
27
Start
15 Feb 2025
Estimated completion
31 Jan 2027

What is this study about?

If you have prostate cancer and are receiving a type of radiotherapy called hypofractionated radiotherapy, this study might be of interest to you. Radiotherapy uses high-energy rays to kill cancer cells, but it's important to protect healthy tissue nearby.

For prostate cancer radiotherapy, having a comfortably full bladder is often helpful. This is because a full bladder moves certain organs, like the small bowel, out of the way of the radiation, which can help reduce side effects. We know from previous studies that if your bladder is often too empty (less than 200 ml) during treatment, you might have more bladder-related side effects, such as irritation or discomfort.

This study is testing a simple idea: can a reminder app on your smartphone help you remember to drink enough water before your radiotherapy sessions? The main goal is to see if using this app means you'll have a suitably filled bladder more often during your treatment. This could potentially lead to fewer bladder-related side effects. The study will compare the app's effect to what we typically see in patients who don't use such an app.

Key takeaways

  • This study is for men with prostate cancer having hypofractionated radiotherapy.
  • It aims to see if a smartphone app can help keep your bladder suitably full during treatment.
  • A fuller bladder might reduce radiotherapy side effects.
  • You need a smartphone and good bladder filling to have been an issue previously.

Who may be eligible?

To join this study, you need to have prostate cancer that has been confirmed by a doctor and be planning to have a specific type of radiotherapy called definitive hypofractionated radiotherapy. You must also own a smartphone and be able to use apps on it. Importantly, your bladder volume needs to have been measured as less than 200ml during a previous scan (CT-simulation) before your radiotherapy starts.

You must be a man, aged 18 years or older, and be able to understand and sign a consent form to show you agree to take part. It's also important that you are generally well enough and able to commit to the study.

You won't be able to join if you're having radiotherapy to your pelvic lymph nodes at the same time, or if the research team believes you might not be able to follow the study instructions properly.

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.

  1. Have I been diagnosed with prostate cancer?
  2. Am I having hypofractionated radiotherapy?
  3. Do I own and use a smartphone?
  4. Was my bladder volume less than 200ml at my CT planning scan?
  5. Am I aged 18 or over?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided here. However, it would typically include downloading and regularly using a special reminder app on your smartphone throughout your course of hypofractionated radiotherapy. This app would prompt you to drink water before each radiotherapy session. The research team would then monitor your bladder volume during your radiotherapy treatments. The total duration of your active participation would likely align with the length of your radiotherapy course, which is typically several weeks.

Potential risks and benefits

The potential benefit of taking part is that using the app might help you maintain a fuller bladder during radiotherapy, which could reduce the risk of bladder-related side effects. There are no known direct risks from using the reminder app itself. The main risk would be the inconvenience of remembering to drink water and follow the app's prompts. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (4)

  • Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark
    Verified postcode
    Vejle, Denmark
  • Medical Practice for Radiotherapy and Radiation Oncology
    Verified postcode
    Hanover, Germany
  • Department of Radiation Oncology, University of Lübeck and University Medical Center Schleswig-Holstein
    Verified postcode
    Lübeck, Germany
  • Radiation Oncology Department, Hospital Universitario Cruces/Biobizkaia Health Research Institute University of the Basque Country
    Verified postcode
    Barakaldo, Spain

Common questions

What kind of bladder problems could radiotherapy cause?

Radiotherapy can sometimes irritate the bladder, leading to symptoms like needing to pee more often, feeling urgent about needing to pee, or experiencing discomfort during urination.

Why is keeping my bladder full important during radiotherapy?

A moderately full bladder helps to move other organs, like your small bowel, out of the way of the radiation, which protects them and can reduce potential side effects.

Will I have to pay for the reminder app?

Clinical trial apps are usually provided to you for free as part of your participation in the study.

How often will the app remind me to drink?

The app would be designed to remind you before each of your radiotherapy sessions to help you achieve the right bladder volume.

What if I forget to use the app or drink water sometimes?

The researchers understand that life happens. The aim is to see if the app *helps* improve bladder filling, not to be perfect every time. Just do your best.

How to find out more

Dirk Rades, Prof. Dr.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Reminder App to Optimize Bladder Filling in Patients with …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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