TRIUMPH v1.0
Research type
Research Study
Full title
TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions
IRAS ID
229246
Contact name
Marcus Drake
Contact email
Sponsor organisation
University of Bristol
ISRCTN Number
11669964
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
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.
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.
TRIUMPH is a trial in men who have bothersome LUTS comparing “usual care” to “personalised care”, which men will receive depending on which group their GP practice is given. 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.
Men with current bothersome LUTS will be invited to participate. They will not be invited (exclusion criteria) if they cannot pass urine without a catheter, have a neurological disease, are being tested for LUTS, treated for prostate or bladder cancer, are under urology review, have had prostate surgery previously, or have poorly-controlled diabetes, visible haematuria, hypercalcaemia or cannot provide informed consent.
Our 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. We estimate that we need to recruit 840 men to detect an important difference in symptom score. We aim to recruit at least 24 GP practices from Bristol and Southampton.
REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0135
Date of REC Opinion
12 Apr 2018
REC opinion
Further Information Favourable Opinion