Condition category
Urological and Genital Diseases
Date applied
11/09/2017
Date assigned
09/10/2017
Last edited
26/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 May 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Bethan Pell
pellb@cardiff.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Bethan Pell

ORCID ID

Contact details

Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
7th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 29 2251 0475
PellB@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36076

Study information

Scientific title

Primary care management of lower urinary tract symptoms in men: Development and validation of a diagnostic and decision-making aid

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

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

Study design

Non-randomised

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Primary care; UKCRC code/ Disease: Renal and Urogenital/ Other diseases of urinary system

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/05/2016

Overall trial end date

30/04/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 880; UK Sample Size: 880

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

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care West of England CRN
-
United Kingdom

Trial participating centre

North East and North Cumbria Clinical Research Network
-
United Kingdom

Trial participating centre

Wales Health Boards
Aneurin Bevan UHB, Cwm Taf UHB, Cardiff and Vale UHB, Abertawe Bro Morgannwg
-
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

Research and Innovation Services
McKenzie House
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 29 2087 9277
FalconerHE@cardiff.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.