Lower urinary tract symptoms Urological and Genital Diseases
Conditions
Interventions
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 ed
Sponsors
University of Bristol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Adult men (aged =18 years) with bothersome LUTS
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower urinary tract symptoms assessed using the IPSS score; Timepoint(s): 12 months after consent | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom, Uruguay
Outcome results
None listed