Urodynamic assessment methods before Prostate Surgery
Research type
Research Study
Full title
A randomised controlled trial to determine the clinical and cost effectiveness of invasive urodynamic studies for diagnosis and management of bladder outlet obstruction in men in the National Health Service (NHS)
IRAS ID
153330
Contact name
Marcus Drake
Contact email
Sponsor organisation
North Bristol NHS TRust
ISRCTN Number
ISRCTN56164274
Research summary
Some men develop difficulty passing urine (voiding) as they age. This may be because an enlarged prostate gland (which sits round the base of the bladder) narrows the bladder outlet (urethra) or because the bladder becomes less able to contract. Prostate surgery is more likely to help symptoms in the first group, while the second group may have no improvement after surgery. Indeed surgery may be the wrong treatment for them, due to risk of complications. Invasive Urodynamics is a diagnostic assessment that can measure some aspects of bladder function. We think that it could be useful to identify the men who should and should not have surgery.
UPSTREAM is a randomised controlled trial designed to find out if the invasive tests are worthwhile assessment in NHS hospitals. The trial will involve 800 men who have bothersome difficulty passing urine and who are considering having surgery for the symptoms. The men will be assigned at random to either invasive urodynamic tests as well as the standard tests (“Invasive urodynamics”) or to the routine standard tests (“Usual care” control arm) alone.We will compare the two diagnostic test methods by finding out if the invasive tests changed the decision for surgery in some of the men (how many men had surgery in each of the two groups?). Secondly we will look at whether the men had similar relief of their symptoms, by measuring the change in the prostate symptom score (IPSS) in the two groups at 18 months after randomisation. In addition, we will be comparing the cost-effectiveness of the two pathways, and the men’s satisfaction with the procedures they had.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0237
Date of REC Opinion
10 Jul 2014
REC opinion
Further Information Favourable Opinion