Primary care management of lower urinary tract symptoms in men
| ISRCTN | ISRCTN10327305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10327305 |
| ClinicalTrials.gov number | NCT03520673 |
| Secondary identifying numbers | CPMS 36076 |
- Submission date
- 11/09/2017
- Registration date
- 09/10/2017
- Last edited
- 03/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
More than 10% of older men experience the need to pass urine more frequently than usual and often find their sleep interrupted by having to go to the toilet during the night. Some will find that their urine flow rate has become slower, and some will experience loss of bladder control. Such problems are distressing for men, affect their work and social life, and are a common reason why men visit a general practitioner (GP) with over 60,000 attendances yearly across the UK. They firstly need reassurance that they are not suffering from cancer or any other sinister medical condition. GPs follow established procedures when considering signs of cancer or these more serious conditions, but they have no easily available assessment tools to identify other more common causes of lower urinary tract symptoms (LUTS), or to advise men about the best treatment options for symptom relief. Because of this, men have to be referred to hospital based urology specialists for tests and diagnosis. The aim of this study is to investigate the accuracy of a new decision aid for use by GPs to diagnose the cause of LUTS in men and to assist decisions in determining appropriate person centred treatment. The aim of the main PriMUS study is to create a practical and accurate ‘decision aid’ to help GPs find out the most likely cause of patients’ lower urinary tract symptoms (LUTS). The GP will then use the decision aid so that they and the patient can choose the best treatment option together. Follow-up is to be conducted at approximately 3-6 months, collating the treatment and management decisions made as a result of these procedures.
Who can participate?
Men aged 16 and older who have a lower urinary tract symptoms.
What does the study involve?
All participants receive the same procedures; including index tests (standard care according to NICE guidance) and a reference test (completed at secondary care level if patient referred to urology). The results of the simple tests with results of urodynamics and identify which simple tests give best prediction of the urodynamic result.
What are the possible benefits and risks of participating?
Participants may benefit from having a very thorough investigation of their urinary symptoms within a few weeks of seeing their GP. This includes an urodynamics test, which is the gold standard test for determining the cause of urinary symptoms and usually takes place once a patient has been referred to hospital. Symptoms might therefore be suitably managed in a shorter timeframe than usual, as a patient’s GP will have all the information they need to make an accurate diagnosis. Patient’s will receive a high street shopping voucher to a maximum value of £30, to cover any travel expenses incurred whilst taking part in the study. There are potential risks with undergoing the urodynamics test. After the test patient’s may experience a mild stinging sensation when they pass urine for a few hours, or in some cases up to a day or so, but these symptoms usually improve quickly. They may also pass a little blood with the urine the first time they pass water. About 5% (five in a hundred) of patients who have this test get a bladder infection (cystitis) afterwards. If this happens the stinging will get worse and they may feel more unwell. If this occurs they should see their GP as soon as possible, and will probably be treated with a course of antibiotics. There is a small risk, (less than one in a hundred) of urine retention (inability to pass water) following the urodynamics test in men with difficulty emptying their bladders, although this rarely occurs. If patients are at all worried they should see their GP as soon as possible.
Where is the study run from?
This study is being run by Cardiff University (UK) and takes place in GP practices across England and Wales recruited from three main research hubs (Newcastle, Bristol and Wales).
When is the study starting and how long is it expected to run for?
May 2017 to April 2021
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Janine Bates, batesmj@cf.ac.uk
Contact information
Public
Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| Phone | +44 (0)2920 687616 |
|---|---|
| batesmj@cf.ac.uk |
Study information
| Study design | Non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Primary care management of lower urinary tract symptoms in men: Development and validation of a diagnostic and decision-making aid |
| Study acronym | PriMUS |
| Study hypothesis | Current study hypothesis as of 12/03/2018: The aim of the PriMUS study is to create a ‘Clinical Decision Support Tool’ to help GPs find out the most likely cause of patients’ urinary symptoms, so that together they can choose the best management. It is believed that this will have many benefits such as getting to the right treatment sooner, avoiding unnecessary hospital visits, and getting those who need to be treated by a specialist there more quickly. Original study hypothesis: The aims of the PriMUS study is to create a ‘decision aid’ to help GPs find out the most likely cause of patients’ urinary symptoms, so that together they can choose the best management. It is believed that this will have many benefits such as getting to the right treatment sooner, avoiding unnecessary hospital visits, and getting those who need to be treated by a specialist there more quickly. |
| Ethics approval(s) | Current ethics approval statement as of 12/03/2018: Wales REC 6, 20/06/2017, ref: 17/WA/0155 Original ethics approval statement: Wales REC 3, 20/06/2017, ref: 17/WA/0155 |
| Condition | Lower urinary tract symptoms |
| Intervention | All patients receive the same treatment. They receive simple index tests, outlining NICE clinical guidance, and all receive the reference test urodynamics. The purpose of the study is to compare the results of all the index tests, with the results of urodynamics, to see whether the index tests can provide an accurate diagnosis and management decision for LUTS. GPs are sent the results of all the index tests and a recommendation for a management decision, to follow up the patient as appropriate. The participants' medical records are reviewed approximately 3-6 months after, to collate the management decision made by the GP. |
| Intervention type | Other |
| Primary outcome measure | Sensitivity and specificity of the diagnoses of detrusor overactivity, bladder outlet obstruction and detrusor underactivity estimated by the decision aid (using invasive urodynamics as the gold standard reference test). |
| Secondary outcome measures | 1. Construction of a patient management algorithm to guide initial treatment for men with LUTS 2. Construction of a prototype online decision aid for use in primary care 3. Qualitative analysis of patients and clinicians views on the use of a LUTS decision aid in the primary care setting 4. Percentage change in referral rates to secondary care for men with LUTS 5. Estimation of costs / savings of implementation of the primary care LUTS decision aid both from a population and individual patient perspective |
| Overall study start date | 01/05/2016 |
| Overall study end date | 30/04/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 880; UK Sample Size: 880 |
| Participant inclusion criteria | 1. Men 2. Aged 16 years and over 3. Present to their GP with a main complaint of one or more lower urinary tract symptoms 4. Able and willing to give informed consent for participation in study 5. Able and willing to undergo all index tests and reference test, and complete study documentation |
| Participant exclusion criteria | Current exclusion criteria as of 12/03/2018 1. Neurological disease or injury affecting lower urinary tract function 2. LUTS considered secondary to current or past invasive treatment or radiotherapy for pelvic disease 3. Contraindications to urodynamics e.g. heart valve or joint replacement surgery within the last 3 months, immunocompromised/immunosuppressed. 4. Indwelling urinary catheter or intermittent self-catheterisation 5. Initial assessment suggests that clinical findings are suggestive of possible: 5.1. prostate or bladder cancer* 5.2. recurrent or persistent symptomatic UTI** 5.3. retention, e.g. palpable bladder after voiding renal impairment 6. Unable to consent in English or Welsh where a suitable translator is not available Original exclusion criteria 1. Neurological disease or injury affecting lower urinary tract function 2. Past or current invasive treatment for LUT malignancy 3. Initial assessment suggests that clinical findings are suggestive of possible: 3.1. Prostate or bladder cancer* 3.2. Recurrent or persistent symptomatic UTI** 4. Unable to consent in English or Welsh where a suitable translator is not available *According to standard NHS cancer pathways. If deemed unlikely, then eligible for study participation. **If UTI successfully treated but LUTS remain, then eligible for study. |
| Recruitment start date | 19/02/2018 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Chepstow
NP16 5PZ
United Kingdom
Newport
NP20 2WQ
United Kingdom
Newbridge
Newport
NP11 4RA
United Kingdom
Cwmbran
NP44 3XQ
United Kingdom
Newport
NP20 5PJ
United Kingdom
Newport
NP20 2LB
United Kingdom
CaerphillyK
CF83 2AX
United Kingdom
Newport
NP20 4EJ
United Kingdom
Cardiff
CF24 1AG
United Kingdom
Barry
CF63 1BA
United Kingdom
Penarth
Vale of Glamorgan
CF64 3XE
United Kingdom
Maelfe
Llanedeyrn
Cardiff
CF28 9PN
United Kingdom
Llandaff
Cardiff
CF5 2DY
United Kingdom
Ely
Cardiff
CF5 4AD
United Kingdom
Cardiff
CF23 5RH
United Kingdom
Cardiff
CF14 2FD
United Kingdom
Park Road
Whitchurch
Cardiff
CF14 7EZ
United Kingdom
Rumney
Cardiff
CF3 3LG
United Kingdom
Whitchurch
Cardiff
CF14 7EZ
United Kingdom
Pontypridd
CF37 2DR
United Kingdom
Mountain Ash
CF45 4EY
United Kingdom
Gilfach Goch
CF39 8TJ
United Kingdom
Penygraig
Tonypandy
CF40 1QN
United Kingdom
Merthyr Tydfil
CF48 1AZ
United Kingdom
Aberdare
CF44 7PA
United Kingdom
Bedlinog
Treharris
CF46 6TE
United Kingdom
High St
Aberdare
CF44 7DD
United Kingdom
Porth
CF39 0LD
United Kingdom
Tonypandy
Rhondda Cynon Taff
CF40 2QZ
United Kingdom
Benton
Newcastle upon Tyne
NE7 7TD
United Kingdom
Percy Main
North Shields
NE29 6HT
United Kingdom
Whitley Bay
NE26 1NA
United Kingdom
Wallsend
NE28 7LP
United Kingdom
Longbenton
Newcastle upon Tyne
NE12 8LS
United Kingdom
Wooler
NE71 6BL
United Kingdom
Infirmary Drive
Alnwick
NE66 2NR
United Kingdom
Berwick-upon-Tweed
TD15 1LL
United Kingdom
Belford
NE70 7ER
United Kingdom
Padgepool Place
Wooler
NE71 6BL
United Kingdom
Berwick-upon-Tweed
TD15 2HB
United Kingdom
Hadston Road
South Broomhill
Morpeth
NE65 9SF
United Kingdom
Corbridge
NE45 5LG
United Kingdom
Corbridge Road
Hexham
NE46 1QJ
United Kingdom
NE43 7LL
United Kingdom
Humshaugh
Hexham
NE46 4BU
United Kingdom
Meadowfield
Ponteland
Newcastle upon Tyne
NE20 9SD
United Kingdom
Hexham
NE48 2HE
United Kingdom
Corbridge Road
Hexham
NE46 1QJ
United Kingdom
Cramlington
NE23 6US
United Kingdom
Seghill
Cramlington
NE23 7SE
United Kingdom
Kingswood
Bristol
BS15 4EJ
United Kingdom
Cadbury Heath
Bristol
BS30 8HS
United Kingdom
Hanham
Bristol
BS15 3HY
United Kingdom
North Common
Bristol
BS30 5JZ
United Kingdom
Westbury On Trym
Bristol
BS9 3AA
United Kingdom
Southmead
Bristol
BS10 6AF
United Kingdom
Henleaze
Bristol
BS9 4HT
United Kingdom
Horfield BS7 0UE
Bristol
BS7 0UE
United Kingdom
8 Brockway
Nailsea
Bristol
BS48 1BZ
United Kingdom
45 Upper Oldfield Park
Bath
BA2 3HT
United Kingdom
Yate
Bristol
BS37 4AX
United Kingdom
Yate
Bristol
BS37 4DQ
United Kingdom
Frampton Cotterell
Winterbourne
Bristol
BS36 2DE
United Kingdom
Sponsor information
University/education
Research and Innovation Services
McKenzie House
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Phone | +44 29 2087 9277 |
|---|---|
| FalconerHE@cardiff.ac.uk | |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/06/2020 | 02/07/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 01/01/2025 | 03/02/2025 | Yes | No |
Editorial Notes
03/02/2025: Publication reference added.
18/10/2021: The public contact was changed. The plain English summary was updated to reflect these changes.
30/09/2020: The recruitment resumed.
02/07/2020: Publication reference added.
05/05/2020: Due to current public health guidance, recruitment for this study has been paused.
10/01/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 31/12/2020.
2. The overall end date was changed from 30/04/2020 to 30/04/2021.
3. The plain English summary was updated to reflect these changes.
19/11/2019: All of the trial participating centres in England have been added to the existing Welsh sites. This information should have been added in March 2018, but was delayed due to an editorial oversight.
21/06/2019: Added ClinicalTrials.gov number.
03/04/2019: The condition has been changed from "Specialty: Primary Care, Primary sub-specialty: Primary care; UKCRC code/ Disease: Renal and Urogenital/ Other diseases of urinary system" to "Lower urinary tract symptoms" following a request from the NIHR.
21/03/2019: The trial participating centres have been added.
14/01/2019: The recruitment end date has been changed from 31/10/2019 to 31/12/2019.
26/03/2018: The following changes have been made:
1. The study hypothesis has had a minor change.
2. The ethics approval statement has been changed.
3. The recruitment start date has been changed from 01/11/2017 to 19/02/2018.
4. The participant exclusion criteria have been changed.
26/10/2017: Internal review.
