An interventional study of Urodynamics and Usual care in Lower Urinary Tract Symptoms, Voiding Dysfunction and Benign Prostate Obstruction, sponsored by North Bristol NHS Trust. Status unknown at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-10.
Sponsored by North Bristol NHS Trust · Not applicable, Interventional, and Diagnostic
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.
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:
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:
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.
31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.
This study's enrollment of 820 is above the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.
Browse Urinary Bladder, Underactive studies →North Bristol NHS Trust is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Compared within Urinary Bladder, Underactive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lower Urinary Tract Symptoms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
"UPSTREAM - Phase I":
Inclusion Criteria:
Exclusion Criteria:
"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:
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:
Invasive urodynamic cystometry including pressure flow studies, along with usual diagnostics in male LUTS
Procedure: Urodynamics · Procedure: Usual care
Usual diagnostics in male LUTS; flow rate test, symptom score and bladder diary
Procedure: Usual care
Diagnostic test for urinary storage and voiding function
Also known as: Cystometry, Pressure flow study
Also known as: Flow rate, Symptom scores, Bladder diary
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)
Time frame: 18 months
Surgery rate
The relative proportion of men in each group having surgery up to 18 months after randomisation
Time frame: 18 months
Cost-effectiveness analyses
Cost effectiveness from the perspectives of the Health Service, Personal Social Services and patients
Time frame: 18 months
Adverse events
Adverse events of testing and treatment (e.g. infection, urinary retention).
Time frame: 18 months
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)
Time frame: 18 months
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.
Time frame: 18 months
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.
Time frame: 18 months
International Prostate Symptom Score (IPSS)
"UPSTREAM - Phase II": difference in lower urinary tract symptom (LUTS)
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
Surgery rate
"UPSTREAM - Phase II": The relative proportion of men in each group having surgery up to 5 years after randomisation
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
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.
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
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.
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
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).
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
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.
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
Plan to share: Yes
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Urinary Bladder, Underactive →
North Bristol NHS Trust