Intervention
LUTS, sleep disturbance
LEAKAGE, INCONTINENCE
The TRIUMPH intervention employed a standardised information booklet. Participants were directed to information within the booklet that was applicable to them via healthcare professional assessment and discussion, providing the manualised element of the intervention. In collaboration with patients, healthcare professionals, and health psychologists, the booklet was developed for the study from patient information sheets produced by the British Association of Urological Surgeons (see supplementary file). The booklet provides targeted guidance on conservative and lifestyle interventions for LUTS in men and is water resistant and able to lie flat for ease of use when opened. Sections are tabbed and colour coded for specific LUTS symptoms and advice.Depending on site preference, participants received the booklet from a general practice clinical nurse, research nurse, healthcare assistant, or trial research nurse. The trial research nurses provided training and ongoing support to the healthcare professionals delivering the intervention. Before the participants attended for an intervention visit, the healthcare professional reviewed the participants’ baseline urinary symptoms, utilising their completed IPSS, International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form, and International Consultation on Incontinence Questionnaire bladder diary. During this visit the healthcare professional discussed the participants’ individual symptoms and how bothersome they were to the participant. The healthcare professionals were provided with decision tools (see supplementary file) enabling them to direct participants to relevant sections of the booklet on the basis of reported symptoms. A maximum of three sections were recommended to each participant and tabbed with discreet stickers. The sections provided advice on drinks and liquid intake, controlling an urgent need to urinate, exercises for the pelvic floor muscles to help stop bladder leakage, emptying the bladder as completely as possible, getting rid of the last drops of urine, and reducing sleep disturbance caused by the need to urinate at nighttime.To encourage and gauge adherence to the intervention, healthcare professionals followed-up the participants by telephone at one week and then by telephone, email, or text at four and 12 weeks, according to the participants’ preference. Participants retained the intervention booklet thereafter. Participants in the intervention arm continued to receive usual care for LUTS from their doctor.The usual care practices were requested to continue standard local management for LUTS. At the end of the study, participants in the usual care arm were provided with the booklet along with a summary of the trial’s results.Participants in both randomised groups were provided with progress updates of the study at three and nine months via a newsletter to maintain engagement with the trial and encourage completion of follow-up questionnaires.