Lower Urinary Tract Symptoms Clinical Trial
— UPSTREAMOfficial title:
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for Diagnosis and Management of Bladder Outlet Obstruction in Men
Verified date | December 2019 |
Source | North Bristol NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background and study aims: The prostate gland sits around the exit of the bladder in men. As
men get older, the prostate grows, and this can narrow the exit from the bladder, so that
there is restriction of flow. As a result, some men develop difficulty passing urine
(voiding) as they age. For these men, prostate surgery can be helpful by removing the part of
the prostate causing the narrowing, so that flow improves. However, for some men, almost
identical symptoms of difficulty passing urine are due to underactive bladder. In other
words, the bladder contraction is too weak, and is not effective at expelling the urine. This
is a smaller group, but important, as these men may have no improvement after prostate
surgery, while being exposed to risk of complications of surgery. Medical assessment of men
with voiding problems typically involves discussing the symptoms, doing a physical
examination of the prostate and measuring the urine flow rate. In many NHS hospitals, these
are the only tests done before deciding whether to proceed to prostate surgery. In effect,
voiding symptoms are presumed to be a result of prostate enlargement for these men, since it
is the more common problem compared with bladder underactivity. However, this approach cannot
identify which men actually have bladder underactivity as the cause of their voiding
symptoms. So, in some hospitals an extra test is used, called urodynamics. Urodynamics is
done to measure how much pressure the bladder generates when passing urine, because a high
pressure shows the problem is obstruction, and a low pressure shows it is bladder weakness.
Urodynamics involves gently putting a small tube into the bladder via the penis to measure
the bladder pressure, and to fill the bladder with a sterile fluid (saline). Another small
tube is gently placed into the rectum, via the anus, to measure abdominal pressures.
Measuring abdominal pressure is necessary because any change in abdominal pressure can affect
bladder pressure, and if the test did not allow for this it could give a misleading result.
Urodynamics is safe, but some men find it uncomfortable or undignified, and a few develop
urine infection afterwards. No studies have been conducted so far to tell us which of these
two approaches to assessing men with voiding urinary problems is better overall.
UPSTREAM consists of two phases: "UPSTREAM - Phase I" was a pragmatic, two-arm, multicentre,
randomised controlled trial (RCT) to determine the clinical and cost-effectiveness of
invasive urodynamics (UDS) for the diagnosis and management of bladder outlet obstruction in
men. Men from 26 urology departments of NHS Hospitals in England who had bothersome lower
urinary tract symptoms (LUTS) and were seeking further treatment, which may have included
surgery, were randomised to one of two study arms; 'Routine Care' (as per the NICE diagnostic
pathway), or routine care plus UDS ('Urodynamics'), which is currently optional. The design
was utilised to establish noninferiority in symptom severity (International Prostate Symptom
Score [IPSS]) 18-months post-randomisation. The primary outcome was IPSS at 18-months
post-randomisation, and a key secondary outcome was the influence of UDS on rates of bladder
outlet surgery. The RCT started 01 April 2014 and ended 30 September 2018.
In 2018, we were awarded an extension to conduct a further (long term) follow up of UPSTREAM
participants, five years post-randomisation; "UPSTREAM - Phase II". We aim to identify: the
symptom outcomes of treatment; definitive surgery rates in the two study arms; and the
long-term impact of LUTS and its therapy. The focus will continue to be on effectiveness and
patient outcomes as per the original commissioning brief. "UPSTREAM - Phase II" started 01
July 2019 and has a planned end date of 30 June 2022.
Status | Active, not recruiting |
Enrollment | 820 |
Est. completion date | June 30, 2022 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
"UPSTREAM - Phase I": Inclusion Criteria: - Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery Exclusion Criteria: - unable to pass urine without a catheter (urinary retention) - relevant neurological disease, such as a stroke - undergoing treatment for prostate or bladder cancer - previously had prostate surgery - not medically fit for surgery, or are unable to complete outcome assessments - do not consent to be assigned at random to one of the pathways "UPSTREAM - Phase II": Inclusion criteria: PROMS (questionnaire) study component: Men randomised (enrolled) to the UPSTREAM trial (Phase I) who were willing to be contacted for long term follow up, as indicated on their original (Phase I) consent form. NHS Digital data extraction study component: Men randomised (enrolled) to the UPSTREAM trial (Phase I). Exclusion criteria: PROMS (questionnaire) study component: 1. Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I) 2. UPSTREAM (Phase I) participants who: 2.1. are not willing to be contacted about long term follow up 2.2. have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3. do not consent and/or are not willing or able to comply with essential study procedures of this further follow up (UPSTREAM - Phase II) NHS Digital data extraction study component: 1. Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I) 2. UPSTREAM (Phase I) participants who have withdrawn permission for the study to continue to access sections of their medical notes and NHS records, ONS and NHS Central registers information, at the time of their 18-month timepoint |
Country | Name | City | State |
---|---|---|---|
United Kingdom | North Bristol NHS Trust | Bristol |
Lead Sponsor | Collaborator |
---|---|
North Bristol NHS Trust | Newcastle University, Royal Devon and Exeter NHS Foundation Trust, University of Aberdeen, University of Bristol, University of Sheffield |
United Kingdom,
Bailey K, Abrams P, Blair PS, Chapple C, Glazener C, Horwood J, Lane JA, McGrath J, Noble S, Pickard R, Taylor G, Young GJ, Drake MJ, Lewis AL. Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial. Trials. 2015 Dec 10;16:567. doi: 10.1186/s13063-015-1087-1. — View Citation
Drake MJ, Lewis AL, Lane JA. Urodynamic Testing for Men with Voiding Symptoms Considering Interventional Therapy: The Merits of a Properly Constructed Randomised Trial. Eur Urol. 2016 May;69(5):759-60. doi: 10.1016/j.eururo.2016.01.035. Epub 2016 Feb 1. — View Citation
Lewis AL, Young GJ, Abrams P, Blair PS, Chapple C, Glazener CMA, Horwood J, McGrath JS, Noble S, Taylor GT, Ito H, Belal M, Davies MC, Dickinson AJ, Foley CL, Foley S, Fulford S, Gammal MM, Garthwaite M, Harris MRE, Ilie PC, Jones R, Sabbagh S, Mason RG, — View Citation
Selman LE, Ochieng CA, Lewis AL, Drake MJ, Horwood J. Recommendations for conducting invasive urodynamics for men with lower urinary tract symptoms: Qualitative interview findings from a large randomized controlled trial (UPSTREAM). Neurourol Urodyn. 2019 — View Citation
Young GJ, Lewis AL, Lane JA, Winton HL, Drake MJ, Blair PS. Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Trials. 2017 Oct 3;18(1):455. doi: 10.1186/s13063-017-2206-y. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Prostate Symptom Score | Primary clinical outcome: difference in lower urinary tract symptom (LUTS) between the two arms at 18 months, measured with the International Prostate Symptom Score (IPSS) | 18 months | |
Secondary | Surgery rate | The relative proportion of men in each group having surgery up to 18 months after randomisation | 18 months | |
Secondary | Cost-effectiveness analyses | Cost effectiveness from the perspectives of the Health Service, Personal Social Services and patients | 18 months | |
Secondary | Adverse events | Adverse events of testing and treatment (e.g. infection, urinary retention). | 18 months | |
Secondary | International Consultation on Incontinence Questionnaires | Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding LUTS severity/ bother, sexual function, quality of life and satisfaction with urodynamic testing. The following will be measured at 6, 12 and 18 months; IPSS (including quality of life) ICIQ Male LUTS (ICIQ-MLUTS) ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex) | 18 months | |
Secondary | Maximum urinary flow rate | Maximum urinary flow rate (Qmax) at 18 months. In men undergoing surgery in both arms, an additional Qmax measure at 4 months after operation will be used as a quality measure for surgery. | 18 months | |
Secondary | EQ-5D-5L | EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). In the descriptive system, respondents rate their health 'TODAY' according to 5 dimensions (Mobility; Self-Care; Usual Activities; Pain/Discomfort; and Anxiety/Depression), with 5 levels of severity (No Problems; Slight; Moderate; Severe; and Extreme Problems). This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome reflecting the patient's own judgement. Full details of the scoring system can be found via the EQ-5D website/user guide. | 18 months | |
Secondary | International Prostate Symptom Score (IPSS) | "UPSTREAM - Phase II": difference in lower urinary tract symptom (LUTS) | 5 years post randomisation ("UPSTREAM - Phase II") | |
Secondary | Surgery rate | "UPSTREAM - Phase II": The relative proportion of men in each group having surgery up to 5 years after randomisation | 5 years post randomisation ("UPSTREAM - Phase II") | |
Secondary | Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding male lower urinary tract symptoms (LUTS) severity/ bother | "UPSTREAM - Phase II": ICIQ Male LUTS (ICIQ-MLUTS); questionnaire evaluating MLUTS and impact on quality of life. 13 items, Scoring: 0-20 voiding symptoms subscale 0-24 incontinence symptoms subscale. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. See https://iciq.net for further information. | 5 years post randomisation ("UPSTREAM - Phase II") | |
Secondary | Measures from the International Consultation on Incontinence Questionnaires Measures from the International Consultation on Incontinence Questionnaires (ICIQ) regarding regarding sexual function | "UPSTREAM - Phase II":ICIQ sexual function in Male LUTS (ICIQ-MLUTS-sex). Patient-complete questionnaire for evaluation of male sexual function associated with their MLUTS and impact of quality of life. 4 items, scoring: 0-12 overall score with greater values indicating increasing problems with sexual matters. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. See https://iciq.net for further information. | 5 years post randomisation ("UPSTREAM - Phase II") | |
Secondary | Quality of Life (QoL) | "UPSTREAM - Phase II": International Prostate Symptom Score (IPSS) including QoL question. The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). | 5 years post randomisation ("UPSTREAM - Phase II") | |
Secondary | EQ-5D-5L | "UPSTREAM - Phase II": EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). In the descriptive system, respondents rate their health 'TODAY' according to 5 dimensions (Mobility; Self-Care; Usual Activities; Pain/Discomfort; and Anxiety/Depression), with 5 levels of severity (No Problems; Slight; Moderate; Severe; and Extreme Problems). This results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome reflecting the patient's own judgement. Full details of the scoring system can be found via the EQ-5D website/user guide. | 5 years post randomisation ("UPSTREAM - Phase II") |
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