What are the possible benefits of taking part?

Participation in the study may help you access treatments that are not normally offered in your local hospital. We cannot promise the study will help you directly. We hope the information we get from this study will help to improve the treatment for patients with symptoms from benign enlarged prostate who require a procedure in the future, as well as the wider NHS by looking at long term cost effectiveness. You will continue to receive NHS care throughout the study, but by taking part, you will have contact with a member of the local research team, which some patients appreciate.  As a thank you for your time, you will receive £25 gift vouchers on completion of the study questionnaires at the 2 years and 3 years after-procedure timepoints.

What are the possible risks of taking part?

For details of the possible side effects for each intervention arm, please refer to the approved patient leaflets that your consultant/health care team will have given you:

• TURP for benign disease
• Rezūm steam ablation of the prostate
• Prostatic Urethral Lift procedure
• Temporary implantable nitinol device (iTIND)

We do not have as much long-term data about the 3 newer procedures compared to TURP, although having a newer procedure does still allow further treatments in the future if required.

What if new information becomes available?

Sometimes during the course of a study, new information becomes available about the procedures being tested. If this happens, your study doctor will tell you about it and discuss with you whether you want to continue in the study.

What will happen if I do not want to carry on with the study / or I later become ineligible for the study treatment?

You are free to withdraw from the study at any time. If you later decide not to have your allocated procedure you can still complete the study follow up and questionnaires if you wish and this would be beneficial to the study. 

You may also choose to only complete the questionnaires if you do not want to attend the study follow up assessments. If you withdraw completely, your care will revert to standard NHS care under your local urology team. We will also continue to collect data on your ongoing urological care (including treatments received and any episodes of urinary retention experienced) up to the 3-year time-point, unless you request us not to. 

An eligibility check will be performed before your allocated procedure to ensure that you still meet the eligibility criteria for the study. If you are found to no longer meet the eligibility criteria you will be withdrawn from the study procedure and will receive treatment according to standard NHS care. You may however still continue with the study follow up and questionnaires if you are willing.

What if something goes wrong?

In the unlikely event something goes wrong and you are harmed during this research due to someone's negligence, then you may have grounds for a legal action for compensation, but you may have to pay your legal costs. NHS Indemnity does not offer no-fault compensation (i.e. for harm that is not anyone’s fault). Newcastle University also has insurance arrangements in place to cover Newcastle University staff involved in designing and managing the study.

Who is organising and funding the study?

This study is funded by the National Institute for Health Research, the national research funder linked to the NHS and the Dept of Health and Social Care.  The doctor in charge of the study (also known as the ‘Chief Investigator’) is Mr Toby Page, Consultant Urological Surgeon based in Newcastle upon Tyne.  This study is sponsored by The Newcastle upon Tyne Hospitals NHS Foundation Trust. The study sponsor has overall responsibility for the study. The study is managed by the Newcastle Clinical Trials Unit, Newcastle University, on behalf of the Sponsor.

How will my information be used?

We will use information from you and your medical records for this research project. This information will include your name, contact details, date of birth, post-code and NHS number. We will ask your surgeon for some information about your procedure to use for the study.  People will use this information to do the research or to check your records to make sure that the research is being done properly. This will include a copy of your consent form being sent to Newcastle University for review and will be deleted as soon as the review is completed. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure.  If you agree to complete the study questionnaires electronically then your email address and mobile number will be stored encrypted within the electronic study database in order to send you links and reminders for your questionnaires. If you choose to complete questionnaires on paper your postal address will be collected in the study database.  Your contact details will be used to send your thank you vouchers.

This information will only be available to authorised members of the study team at your hospital and authorised members of the PREMISE management team at Newcastle University. The contact details will be removed from the database as soon as the study is
completed.  Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study. We may also share the data from this study with other researchers in the UK and abroad. It will not be possible to identify you from this data. We must archive all study information for at least 5 years after the study ends. Your name and contact details will be stored by your hospital. Any study data held by the study team at Newcastle University will have a code number instead of your name. If you provide an email address and mobile number for completion of the study questionnaires this information will remain encrypted in the database downloads during the archiving period.

Will my taking part be kept confidential?

Your participation in the study will be confidential, however we will let your GP know that you are taking part so that they are aware in case you contact them about any medical problem, as well as the doctor/care team who referred you for the study. They will also be given a copy of this information.

All the information you provide during the course of this study will be securely stored Only authorised members of the study team at your hospital and Newcastle University will be granted access to the information collected during the study.

The study team at your hospital will have access to your medical records during the study to organise your procedure and appointments, as well as for ongoing safety.

Some parts of your medical records and the data collected for the study may also be looked at by authorised persons from the Newcastle upon Tyne Hospitals NHS Foundation Trust and/or the Newcastle Clinical Trials Unit to check that the study is being conducted to the correct standards. All will have a duty of confidentiality to you as a research participant.

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have

If you choose to stop taking part in the study, we would like to continue collecting information about your health from your hospital. If you do not want this to happen, tell us and we will stop.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

Where can I find out more about how my information is used?

• our leaflet available from www.hra.nhs.uk/patientdataandresearch
• by asking one of the research team
• by sending an email to the Sponsor Data Protection Officer at nuth.dpo@nhs.net

Who has reviewed the study?

The funder reviewed the study plan as part of the application for funding. All research in the NHS is also looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed by Preston Research Ethics Committee and a favourable opinion given as well as being approved by the Health Research Authority (HRA). The Newcastle Upon Tyne Hospitals NHS Foundation Trust has reviewed all the study documentation and assessed the risks of this study as part of our responsibility as study Sponsor.