UPSTREAM Phase II - Further Follow Up Study
Research type
Research Study
Full title
UPSTREAM (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods) Phase II – Further Follow Up Study.
IRAS ID
264738
Contact name
Marcus Drake
Contact email
Sponsor organisation
North Bristol NHS Trust, Research & Innovation
Clinicaltrials.gov Identifier
ISRCTN56164274, ISRCTN; NCT02193451, ClinicalTrials.gov
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Between 2014 and 2018, 820 men enrolled in the UPSTREAM study (“Phase I”) because they had bothersome lower urinary tract symptoms (LUTS) and were seeking further treatment. When referred to hospital, men with bothersome LUTS are assessed with a set of standard assessments (tests). UPSTREAM set out to see whether including an extra assessment called “urodynamics” helps when considering treatment options.
Men were split into two groups to receive either standard assessments (routine care) or routine care plus urodynamics. All men then discussed the test results with their urologist and decided what treatment to have. 18-months after they enrolled, they completed a questionnaire booklet about their urinary symptoms, the effect on their everyday life, and their general state of health, and identified what treatment they had received.
During “UPSTREAM – Phase I”, however, we identified that there is significant variation in the assessment pathway in 26 hospitals across England, including duration, as well as in patient factors. Several patients had not fully completed their LUTS treatment at the 18-month follow up, or had completed it less than 6-months beforehand; clinically, a 12-month timeframe is appropriate to show the immediate impact of surgery.
Additional funding was therefore awarded to conduct a long term (5-year) follow up of UPSTREAM participants. In “UPSTREAM – Phase II” we want to find out the 5-year results of treatment for the men’s LUTS, and see how many men went on to receive surgery after the initial 18-months (i.e. after “UPSTREAM - Phase I”).
During “UPSTREAM – Phase II” (01 July 2019 to 30 June 2022), we will ask existing UPSTREAM participants to complete one questionnaire booklet about their urinary symptoms, the effect on their everyday life, and their general state of health. We will also securely collect relevant information from central NHS records.
Research Summary:
Lower urinary tract symptoms are common in older men and can require treatment. The UPSTREAM study (Phase I) investigated whether assessment of these symptoms with invasive urodynamic testing could help guide treatment options and so improve symptoms as measured by the International Prostate Symptom Score (IPSS). Men were randomly assigned to have urodynamic testing or routine NHS care. We followed up all men in Phase I for 18 months, but found that some were still waiting for treatment at the end of the study.
Phase II of UPSTREAM followed up men from Phase I until they were at five-years from entering the study. We aimed to assess their lower urinary tract symptoms and find out how many men had undergone prostate surgery. We asked men to complete a questionnaire including the IPSS and quality of life measures via post, online or telephone. We also used routinely collected NHS data to gather information on prostate operations and use of hospital services.
Of the 820 participants in Phase I, 416 completed a five year questionnaire and NHS routine data were available for 801. At 18-months, symptoms had reduced from baseline with a similar reduction in both groups (men who did and didn’t have urodynamic testing). We saw a slight increase in symptoms between 18-months and five-years, with no big difference between the two groups. 43% of men had received surgery for their urinary symptoms by five-years. There were no big differences between the groups in use of hospital services or quality of life.
UPSTREAM Phase II showed that, although urodynamics was no worse than routine care in terms of symptoms at 18-months, at five-years there was no difference between the two groups in the proportion of men receiving surgery or their symptoms, quality of life or use of hospital services.REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0578
Date of REC Opinion
1 Nov 2019
REC opinion
Favourable Opinion