Participants
neurological disease, prostate, haematuria, LUTS, prostate or bladder cancer
POORLY CONTROLLED DIABETES MELLITUS, HAEMATURIA, NEUROLOGICAL DISEASE, PROSTATE
Men aged 18 years or older who had presented to primary care with LUTS within the past five years according to general practice records and were currently experiencing at least one bothersome LUTS were potentially eligible for the study. Men were excluded if they lacked capacity to consent, were unable to pass urine without a catheter (indwelling or intermittent catheterisation), had a relevant neurological disease or referral, were undergoing urological testing for LUTS, were being treated for prostate or bladder cancer, had undergone prostate surgery, had poorly controlled diabetes mellitus, were recently referred or currently under urology review, had visible haematuria, or were unable to complete trial assessments in English.The general practices conducted a single database search designed specifically for the trial to identify potentially eligible patients, and the general practitioners manually verified the findings using electronic medical records. To avoid any bias in patient selection, each site conducted a single mail out to potentially eligible patients before notification of its randomisation status. While masked to the allocation of the practice and to avoid bias, NIHR Clinical Research Network nurses or clinical practitioners trained by the trial team telephoned patients expressing an interest in taking part in the study. Calls were conducted to confirm eligibility, particularly the subjective criterion of whether LUTS were currently bothersome to the patient, as initial screening by the general practices only identified men coded with LUTS within the preceding five years. The telephone calls also ensured that patients understood the study, answered any questions, and confirmed their willingness to participate in the study.Patients deemed willing and eligible completed a postal consent form and questionnaire containing baseline measures. All patients received the same consent form and questionnaires, but those in the intervention arm also received a bladder diary to be completed before their face-to-face visit for assessment of symptoms. Participants remained blinded to their treatment arm while completing baseline measures and were not aware that completion of the bladder diary indicated randomisation to the intervention arm. Participants assigned to receive the intervention did not have sight of the booklet until after consent had been obtained, and participants assigned to receive usual care remained unaware of the content of the booklet throughout the trial.