TreatIng urinary symptoms in men in primary healthcare using non-pharmacological and non-surgical interventions
| ISRCTN | ISRCTN11669964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11669964 |
| Secondary identifying numbers | 37405 |
- Submission date
- 12/03/2018
- Registration date
- 12/04/2018
- Last edited
- 09/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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 January 2021
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
Contact information
Scientific
Population Health Sciences
Bristol Medical School
University of Bristol
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-2860-3511 |
|---|---|
| triumph-study@bristol.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Education or Self-Management, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions |
| Study 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(s) | North West - Preston Research Ethics Committee, 12/04/2018, ref: 18/NW/0135 |
| Condition | Lower urinary tract symptoms |
| 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 |
| Primary outcome measure | 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 study start date | 01/11/2017 |
| Overall study end date | 31/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 840; UK Sample Size: 840 |
| Total final enrolment | 1076 |
| Participant inclusion criteria | Adult men (aged ≥18 years) with bothersome LUTS |
| 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 | 01/08/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
- Uruguay
Study participating centres
United Kingdom
United Kingdom
Uruguay
Sponsor information
University/education
Research and Enterprise Development
3rd Floor, Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
| Phone | +44 (0)117 928 8676 |
|---|---|
| abc@email.com | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/01/2022 |
|---|---|
| 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 | 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 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 | 02/09/2019 | 08/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 15/11/2023 | 16/11/2023 | Yes | No | |
| Results article | Costs and QALYs results | 30/01/2024 | 09/02/2024 | Yes | No |
Editorial Notes
09/02/2024: Publication reference added.
16/11/2023: Publication reference added.
08/06/2023: Publication reference added.
30/08/2019: The following changes were made to the trial record.
1. The recruitment end date was changed from 31/07/2019 to 01/08/2019.
2. The overall trial end date was changed from 31/10/2020 to 31/01/2021.
3. The intention to publish date was changed from 31/10/2021 to 31/01/2022.
4. The total final enrolment number was added.
17/05/2019: The recruitment end date was changed from 30/04/2019 to 31/07/2019.
17/04/2019: The condition has been changed from "Malignant neoplasm of bladder or prostate" to “Lower urinary tract symptoms”.
27/03/2019: The condition has been changed from "Specialty: Primary care, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of the genitourinary system" to "Malignant neoplasm of bladder or prostate" following a request from the NIHR.
