Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods

Summary

Participation Requirements

Description

The aim of the UPSTREAM trial ("UPSTREAM - Phase I") was to determine whether a care pathway including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is not included, at 18 months after randomisation. We also aimed to establish whether inclusion of invasive...

The aim of the UPSTREAM trial ("UPSTREAM - Phase I") was to determine whether a care pathway including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is not included, at 18 months after randomisation. We also aimed to establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome. The following men were invited to participate (inclusion criterion); • Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery Men were not invited to participate (exclusion criteria) if they: were unable to pass urine without a catheter (urinary retention) had a relevant neurological disease, such as a stroke were undergoing treatment for prostate or bladder cancer had previously had prostate surgery were not medically fit for surgery, or were unable to complete outcome assessments did not consent to be assigned at random to one of the pathways We compared the two methods of investigation by finding out 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 (primary outcome). We also looked at the following secondary outcomes: Whether the invasive tests changed the decision for surgery in some of the men (how many men had surgery in each of the two groups?) The cost-effectiveness of the two management pathways Adverse effects of (a) the tests and (b) the treatments (e.g. urinary infection, urinary retention) Urinary symptoms at 6, 12 & 18 months, using the International Consultation on Incontinence Questionnaires (ICIQ) and the Male Lower Urinary Tract Symptoms questionnaire (ICIQ-MLUTS) Quality of life, using the IPSS-QoL question Sexual function, using the ICIQ-MLUTS sex questionnaire Satisfaction with urodynamic testing, using the ICIQ-UDS-S questionnaire The maximum urinary flow rate (Qmax) at 18 months Health outcomes, using the EQ-5D-5L questionnaire For "UPSTREAM - Phase II". In this further follow up study ("UPSTREAM - Phase II"), we want to find out the longer term (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 the original study, "UPSTREAM - Phase I"). We will approach existing participants of the UPSTREAM trial ("UPSTREAM - Phase I"). In taking part in "UPSTREAM - Phase II", men do not need to return to hospital for any clinical assessments. Instead we will ask them 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 information relevant to this study from central NHS records (such as information about relevant inpatient stays and outpatient attendances). Outcome measures will include: LUTS will be measured with the widely-used patient reported outcome, the International Prostate Symptom Score (IPSS), at five years post-randomisation. • Measures from the International Consultation on Incontinence Questionnaires (ICIQ) will also be used, giving sensitive and comprehensive assessment of LUTS severity/ bother, sexual function and quality of life (QoL), i.e.: O IPSS QoL O ICIQ Male LUTS (ICIQ-MLUTS) O ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex) The EQ-5D-5L will be used to provide the QoL weights used to calculate Quality Adjusted Life Years (QALYs). Data for: Surgery rates (the relative proportion of men in each group having surgery up to five years post-randomisation); diagnostic testing after the main trial (where possible); and resource use will be obtained via a one-off bespoke data extraction of Health Episode Statistics (HES) and HES-Office of National Statistics (ONS) linked data, via NHS Digital. This will include individual level data about participants' relevant: inpatient stays; outpatient attendances: including procedures; radiology and accident and emergency (A&E) episodes; and cause of death (where applicable).

Tracking Information