Less to Hold
Research type
Research Study
Full title
A comparison of bladder toxicities (side effects) in patients undergoing prostate radiotherapy between patients treated with empty bladder and those on a drinking protocol.
IRAS ID
215960
Contact name
Alison Birtle
Contact email
Sponsor organisation
Lancashire Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
Prostate radiotherapy at Preston is conventionally delivered to patients when they have a full bladder. We know from the literature having an empty bladder has no detriment to treatment outcomes and that some centres are treating with empty bladders. There is however no published data showing that bladder or bowel toxicities (side effects) are no worse in empty bladder treatment. We are designing a study to look at the bladder and bowel toxicities (side effects) in patients undergoing radiotherapy to the prostate and comparing the severity between patients treated with a full bladder and those treated with an empty bladder. This is a non-inferiority feasibility study. We will randomise patients to either empty bladder or full bladder for the duration of their radiotherapy and monitor their urinary and bowel toxicities (side effects) at baseline and then weekly during treatment. We will be using standardised questionnaires to assess their symptoms and also the impact on their quality of life. We will also check at the radiotherapy planning stage the dose volume histograms (DVHs - radiotherapy dose calculations) for the bladder and bowel, to assess if we are easily meeting the tolerance limits in both groups or if changes to the plans are required. Images will also be checked during treatment as is the case routinely to ensure the area to be treated is being covered adequately in both groups.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0467
Date of REC Opinion
10 Nov 2016
REC opinion
Unfavourable Opinion