“UPSTREAM – Phase II”
We invite you to take part in the 5-year follow up of the UPSTREAM study (“UPSTREAM – Phase II”).
Please note: The “UPSTREAM - Phase II” study is active; it formally started on 01 July 2019 and will run through to 30 June 2022 (may be subject to change).
- You previously took part in the UPSTREAM study (“UPSTREAM – Phase I”) because you had urinary problems such as difficulty passing urine, or frequent and urgent need to pass urine (lower urinary tract symptoms (LUTS)). We monitored your symptoms and the treatment you received for 18-months. You agreed to be contacted about a longer term follow up.
- We now want to establish the longer term (5-year) results of any treatment that you received for your LUTS, and what extra treatment may have been needed after the initial 18-months (“UPSTREAM – Phase II”).
- In taking part in “UPSTREAM - Phase II”, you do not need to return to hospital for any clinical assessments. Instead we will ask you to complete one questionnaire booklet about your urinary symptoms, their effect on your everyday life, and your general state of health. To thank you for your time we will offer you a £20.00 gift voucher upon receipt of your completed questionnaire.
- We will also securely collect information relevant to this study from central NHS records. For example, information about relevant inpatient stays and outpatient attendances, and where applicable, death.
- By taking part in this study, you will be providing evidence for future men with bothersome LUTS who may be faced with similar decisions you and your urologist have had about assessing and treating your condition.
- You can stop taking part in this study at any time.
- Full details about the 5-year follow up of UPSTREAM study (“UPSTREAM – Phase II”) can be found in the Participant Information Sheet, below.
Please contact a member of the UPSTREAM Study Office if there are any parts of this information that you do not understand, or you would like further information on.
Participant Information Sheet (“Phase II”)
Supporting information about accessing information from hospital and/or central NHS records
North Bristol NHS Trust is the Sponsor for this study based in the United Kingdom (UK). The Bristol Randomised Trials Collaboration (BRTC), as part of the Bristol Trials Centre (BTC), University of Bristol (UK), are responsible for managing the study. North Bristol NHS Trust and the University of Bristol act as joint data controllers for this study. This means that we are responsible for looking after your information and using it properly.
When taking part in the original study (“UPSTREAM – Phase I”) you agreed that we can access relevant information from hospital and/or central NHS records (such as NHS Central Registers, or other registries including those managed by NHS Digital (formerly Health and Social Care Information Centre), including Hospital Episode Statistics (HES) and Office for National Statistics (ONS)). NHS Digital handles information from healthcare organisations in England and Wales, including dates and details for hospital admission/ attendance and where applicable, cause of death. This information will be kept secure and confidential. To access this information, we will securely share some identifiable information with NHS Digital, such as your study number, NHS number, date of birth and gender.
The above information, alongside further details about the study and your data are included in the UPSTREAM Phase II Patient Information Sheet (PDF, 421kB) (PART C).
To help your understanding:
- NHS Digital handles information from healthcare organisations in England and Wales. They maintain two databases called HES (Hospital Episode Statistics) and ONS (Office for National Statistics).
- Hospital Episode Statistics (HES). The NHS collects Hospital Episode Statistics information on all hospital admissions/ attendances, including when, why and for how long they happen. By collecting information from HES, we can tell what happens to a participant’s health during the study. For example, if someone is admitted to hospital this will be recorded. By doing this, it means that we can use the information the NHS already collects rather than do extra study follow ups, for example.
- Office for National Statistics (ONS). When someone dies in England, this is recorded in civil registration data. This includes the date and cause of death. The Office for National Statistics can make these data available for research through NHS Digital. As well as providing information about date and cause of death, this reduces the chances of us sending mail, messages or calls to patients who are no longer alive, which might upset relatives or friends.