Inclusion criteria

Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery.

Exclusion criteria

Patients who:

• are unable to pass urine without a catheter (urinary retention) (excluding CISC after void to empty)
• have a relevant neurological disease such as stroke, multiple sclerosis, Parkinson’s disease, or Spina bifida (diabetes mellitus is not an exclusion criterion unless it is causing diabetic neuropathy)
• undergoing active treatment, or on active surveillance, for prostate or bladder cancer (including AS for low grade/stage and H1Ta TC)
• have previously had prostate surgery
• are not medically fit for surgery, or are unable to complete outcome assessments
• do not consent to be randomised and/or are not willing or able to comply with essential study procedures. 

About the UPSTREAM trial

Ethics and research governance

The UPSTREAM trial has full ethical approval from South Central Oxford B Research Ethics Committee (REC Ref: 14/SC/0237). Necessary approvals from the participating hospitals and lead urology consultant are also gained prior to recruitment start at each centre. For copies of ethics approval please contact the trial manager, Dr Amanda Lewis on 0117 331 3907 or by emailing amanda.lewis@bristol.ac.uk.

Funding / sponsorship

This project was funded by the National Institute for Health Research HTA programme (project number 12/140/01). North Bristol NHS Trust Research and Innovation (NCT R&I) sponsor the UPSTREAM trial (Ref: 3250).

Study registration

ISRCTN56164274

Study steering committee

An independent Steering Committee and a Data Monitoring Committee monitor safety and ensure that the study is conducted in accordance with good research practice.

Recruitment

The UPSTREAM trial aims to recruit 800 men from at least 19 urology departments of NHS hospitals in the UK. These currently include: Birmingham, Bristol, Epsom, Exeter, East Kent and Canterbury, Kettering, King’s Lynn, Kingston-upon-Thames, Liverpool, Middlesbrough, Newcastle, Oxford, Royal Free (London), Salisbury, Sheffield, Southport, Stevenage, Taunton and Torbay. Additional sites will be identified if required.

If you are interested in taking part in the UPSTREAM (either as a patient or a recruitment centre), please contact the trial manager, Dr Amanda Lewis on 0117 331 3907 or by emailing UPSTREAM-trial@bristol.ac.uk.