Condition category
Urological and Genital Diseases
Date applied
12/03/2018
Date assigned
12/04/2018
Last edited
12/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Lower Urinary Tract Symptoms (LUTS) refer to problems with storing urine, such as increased urinary daytime frequency, urgency, having to pass urine overnight, slow stream while passing urine, or dribbling afterwards. Half of men over 40 experience at least one LUTS, which can have a significant impact on their daily lives. The aim of this study is to test whether personalised advice based on a nurse’s assessment of men’s urinary symptoms improves symptom control.

Who can participate?
Men aged 18 and over with current bothersome LUTS

What does the study involve?
Participating GP practices are randomly allocated to provide either usual care or personalised care. Men in the personalised care group are offered non-drug therapy, based on an assessment by a nurse. The nurse educates the patient on LUTS, teaches him the appropriate treatments and provides written information. Ongoing support is offered to help men adhere to the treatments. Treatment advice may include advice on drinks, pelvic muscle exercises, bladder training and techniques to reduce urinary dribbling. The aim is to find out whether personalised standard treatment achieves better symptom relief than usual care by comparing the change in symptoms between the two groups after a year.

What are the possible benefits and risks of participating?
If they are in the personalised booklet group, they will receive a booklet to keep with personalised information and advice on their symptoms. If they are in the usual care group, they will have access to the booklet at the end of the study. Their symptoms may improve and bother them less. Even if they do not feel any improvement, their taking part will help us to understand what advice and information will help improve LUTS in other men, without having surgery or drugs to help their symptoms. We do not anticipate any disadvantages in taking part. However, we do not know how much their symptoms will improve, whichever group they are in. Therefore, their symptoms may not improve as much as they would like. They will need to spend time completing questionnaires, and if they are in the personalised advice group they will be asked to spend time following the advice given.

Where is the study run from?
1. University of Bristol (UK)
2. University of Southampton (UK)
3. At least 24 GP practices from Bristol and Southampton (UK)

When is the study starting and how long is it expected to run for?
November 2017 to October 2020

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

Who is the main contact?
Dr Jo Worthington
triumph-study@bristol.ac.uk

Trial website

https://www.journalslibrary.nihr.ac.uk/programmes/hta/169003/#/

Contact information

Type

Scientific

Primary contact

Dr Jo Worthington

ORCID ID

http://orcid.org/0000-0002-2860-3511

Contact details

Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
-
triumph-study@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37405

Study information

Scientific title

TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions

Acronym

TRIUMPH v1.0

Study hypothesis

Lower Urinary Tract Symptoms (LUTS) refer to problems with storing urine, such as increased urinary day-time frequency, urgency, having to pass urine overnight, slow stream while passing urine, or dribbling afterwards. Half of men over 40 experience at least one LUTS, which can have a significant impact on their daily lives.

The TRIUMPH (TReating Urinary symptoms in Men in Primary Healthcare) study will test whether personalised advice based on a nurse’s assessment of men’s urinary symptoms achieves improved symptom control over usual care.

Ethics approval

North West - Preston Research Ethics Committee, 12/04/2018, ref: 18/NW/0135

Study design

Randomised; Both; Design type: Treatment, Education or Self-Management, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Primary care, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of the genitourinary system

Intervention

GP practices are randomised to deliver either usual care or personalised care. Men in the personalised care group will be offered non-drug therapy, based on an assessment by a nurse. The nurse will educate the patient on LUTS, teach him the appropriate treatment(s) and provide written information. Ongoing support will be offered to help men adhere to the treatments. Treatment advice may include advice on drinks, pelvic muscle exercises, bladder training and techniques to reduce urinary dribbling.

The primary outcome is to find out if personalised standard treatment achieves better symptom relief overall than usual care, by comparing the change in a prostate symptom score (IPSS) between the two groups after a year. The treatment phase is 12 weeks, and follow up is at 6 and 12 months after consent. Each patient will be in the study for 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Lower urinary tract symptoms assessed using the IPSS score; Timepoint(s): 12 months after consent

Secondary outcome measures

1. LUT-specific QoL, assessed using IPSS QoL at 6 and 12 months
2. Symptoms scores at 6 months (IPSS overall score) and 6 and 12 months (ICIQ-UI-SF)
3. Cost-effectiveness analyses from an NHS perspective. The EQ-5D-5L will be used to calculate QALYs at 12 months
4. Number of adverse events (e.g. infection, urinary retention) at 12 months
5. Number of GP consultations at 12 months
6. Number of referrals to secondary care at 12 months
7. Overall quality of life measured by the EQ-5D-5L at 12 months
8. A qualitative element of the research study will evaluate patient experiences of intervention throughout the trial

Overall trial start date

01/11/2017

Overall trial end date

31/10/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Adult men (aged ≥18) with bothersome LUTS

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 840; UK Sample Size: 840

Participant exclusion criteria

1. Lack of capacity to consent
2. Unable to pass urine without a catheter (indwelling or intermittent catheterisation)
3. Relevant neurological disease including referral to neurology
4. Undergoing urological testing for LUTS
5. Currently being treated for prostate or bladder cancer
6. Previous prostate surgery
7. Unable to complete assessments in English
8. Poorly-controlled diabetes mellitus
9. Recently referred or currently under urology review
10. Visible haematuria
11. Hypercalcaemia
Eligibility will be checked by the patient's own GP as part of the screening process

Recruitment start date

01/05/2018

Recruitment end date

30/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
BS8 1TH

Trial participating centre

University of Southampton
SO17 1BJ

Trial participating centre

At least 24 GP practices from Bristol and Southampton
-

Sponsor information

Organisation

University of Bristol

Sponsor details

Research and Enterprise Development
3rd Floor
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom
+44 (0)117 928 8676
abc@email.com

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/90/03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/169003/#/. Planned publication of the results 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

31/10/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes