Lower Urinary Tract SymptomsUPSTREAMNCT02193451
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods
A study testing Urodynamics in people with Lower Urinary Tract Symptoms and Voiding Dysfunction, run by North Bristol NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Voiding Dysfunction, Benign Prostate Obstruction
- What is being tested?
- Urodynamics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery
- 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).
Who cannot join
- 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
Show all 14Show fewer
- "UPSTREAM - Phase II":
- PROMS (questionnaire) study component:
- Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
- 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 have withdrawn trial participation, or at least withdrawn permission to be contacted in the future for long term follow up, at the time of their 18-month timepoint 2.3.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:
- Patients who are not already randomised (enrolled) to the UPSTREAM trial (Phase I)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for Diagnosis and Management of Bladder Outlet Obstruction in Men
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.
Read the detailed 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 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).
- Conditions
- Lower Urinary Tract Symptoms, Voiding Dysfunction, Benign Prostate Obstruction, Detrusor Underactivity
- Being tested
- Urodynamics, Usual care
- Keywords
- Lower urinary tract symptoms, Male LUTS, Voiding dysfunction, Benign prostate obstruction, Detrusor underactivity
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Bladder, Underactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrodynamicsProcedure or surgery
Also called Cystometry, Pressure flow study
Diagnostic test for urinary storage and voiding function
Usual careProcedure or surgery
Also called Flow rate, Symptom scores, Bladder diary
| Study group | Role | What they receive |
|---|---|---|
| Urodynamics | Experimental | Invasive urodynamic cystometry including pressure flow studies, along with usual diagnostics in male LUTS Receives: Procedure: Urodynamics; Procedure: Usual care |
| Usual care | Active comparator | Usual diagnostics in male LUTS; flow rate test, symptom score and bladder diary Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18 months
Secondary outcomes (12)
Surgery rate
The relative proportion of men in each group having surgery up to 18 months after randomisation
Measured: 18 months
Cost-effectiveness analyses
Cost effectiveness from the perspectives of the Health Service, Personal Social Services and patients
Measured: 18 months
Adverse events
Adverse events of testing and treatment (e.g. infection, urinary retention).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 18 months
International Prostate Symptom Score (IPSS)
"UPSTREAM - Phase II": difference in lower urinary tract symptom (LUTS)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 5 years post randomisation ("UPSTREAM - Phase II")
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2018
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol, University of Aberdeen, Newcastle University, Royal Devon and Exeter NHS Foundation Trust, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Marcus Drake, DM, MA, FRCS(Urol), Principal investigator, University of BristolAthene Lane, PhD, Study director, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193451
- Sponsor's protocol ID
- UPSTREAM 3250
- Other IDs
- 12/140/01
- Acronym
- UPSTREAM
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2014
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 28974250Bailey 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.
PubMed 26651344Drake 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.
PubMed 26847139Selman 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 Jan;38(1):320-329. doi: 10.1002/nau.23855. Epub 2018 Oct 12.
PubMed 30311686Lewis 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, McLarty E, Mishra V, Mom J, Morley R, Natale S, Nitkunan T, Page T, Payne D, Rashid TG, Saeb-Parsy K, Sandhu SS, Simoes A, Singh G, Sullivan M, Tempest HV, Viswanath S, Walker RMH, Lane JA, Drake MJ. Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Eur Urol Focus. 2019 May;5(3):340-350. doi: 10.1016/j.euf.2019.04.006. Epub 2019 Apr 30.
PubMed 31047905Wei DY, Drake MJ. Undiagnosed neurological disease as a potential cause of male lower urinary tract symptoms. Curr Opin Urol. 2016 Jan;26(1):11-6. doi: 10.1097/MOU.0000000000000243.
PubMed 26555692
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for Diagnosis and Management of Bladder Outlet Obstruction in Men
- ClinicalTrials.gov ID
- NCT02193451
- Acronym / sponsor ID
- UPSTREAM / UPSTREAM 3250
- Conditions
- Lower Urinary Tract Symptoms, Voiding Dysfunction, Benign Prostate Obstruction, Detrusor Underactivity
- Keywords
- Lower urinary tract symptoms, Male LUTS, Voiding dysfunction, Benign prostate obstruction, Detrusor underactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 820 participants (actual)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Collaborators
- University of Bristol, University of Aberdeen, Newcastle University, Royal Devon and Exeter NHS Foundation Trust, University of Sheffield
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urodynamics | Experimental | Procedure: Urodynamics, Procedure: Usual careInvasive urodynamic cystometry including pressure flow studies, along with usual diagnostics in male LUTS |
| Usual care | Active comparator | Procedure: Usual careUsual diagnostics in male LUTS; flow rate test, symptom score and bladder diary |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men seeking further treatment for their bothersome lower urinary tract symptoms (LUTS) which may include surgery
- 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.
- Men randomised (enrolled) to the UPSTREAM trial (Phase I).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UrodynamicsAlso: Cystometry, Pressure flow studyDiagnostic test for urinary storage and voiding function | Procedure or surgery | Urodynamics |
| Usual careAlso: Flow rate, Symptom scores, Bladder diary | Procedure or surgery | Urodynamics, Usual care |
Primary outcome
International Prostate Symptom Score
Time frame: 18 months
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)
12 secondary outcomes
Surgery rate
Time frame: 18 months
Cost-effectiveness analyses
Time frame: 18 months
Adverse events
Time frame: 18 months
International Consultation on Incontinence Questionnaires
Time frame: 18 months
Maximum urinary flow rate
Time frame: 18 months
EQ-5D-5L
Time frame: 18 months
International Prostate Symptom Score (IPSS)
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
Surgery rate
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
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
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
Quality of Life (QoL)
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
EQ-5D-5L
Time frame: 5 years post randomisation ("UPSTREAM - Phase II")
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 28974250Young 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.
- Background: PubMed 26651344Bailey 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.
- Background: PubMed 26847139Drake 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.
- Results publication: PubMed 30311686Selman 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 Jan;38(1):320-329. doi: 10.1002/nau.23855. Epub 2018 Oct 12.
- Results publication: PubMed 31047905Lewis 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, McLarty E, Mishra V, Mom J, Morley R, Natale S, Nitkunan T, Page T, Payne D, Rashid TG, Saeb-Parsy K, Sandhu SS, Simoes A, Singh G, Sullivan M, Tempest HV, Viswanath S, Walker RMH, Lane JA, Drake MJ. Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). Eur Urol Focus. 2019 May;5(3):340-350. doi: 10.1016/j.euf.2019.04.006. Epub 2019 Apr 30.
- Derived from this study: PubMed 26555692Wei DY, Drake MJ. Undiagnosed neurological disease as a potential cause of male lower urinary tract symptoms. Curr Opin Urol. 2016 Jan;26(1):11-6. doi: 10.1097/MOU.0000000000000243.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Drake, DM, MA, FRCS(Urol) principal investigator
University of Bristol
Athene Lane, PhD study director
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamics in people with Lower Urinary Tract Symptoms and Voiding Dysfunction, run by North Bristol NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193451, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.