Outcomes
deaths, LUTS, prostatitis, urinary retention
PROSTATITIS, URINARY TRACT INFECTIONS, INCONTINENCE, ADVERSE EVENTS, SECONDARY
The primary outcome measure was the validated patient reported IPSS at 12 months after consent to participate in the study—a score that is extensively used in LUTS research and widely employed in urology services.Secondary outcomes collected by questionnaire at baseline and six and 12 months after consent comprised the IPSS quality of life (LUTS related quality of life score, six and 12 months), the IPSS (overall score for urinary symptoms, six months), the International Consultation on Incontinence Questionnaire Urinary Incontinence-Short Form symptoms score (six and 12 months,The number of LUTS related adverse events (prespecified as urinary tract infections, catheterisations, urinary retention, prostatitis), deaths, and the number of referrals to secondary care (urology) at 12 months post-consent were extracted from primary care electronic medical records through trial specific automated database searches. These searches were conducted a minimum of one month after the final participant for each site had completed follow-up. The sites provided the central trial team with anonymised data extracts for analysis.Case report forms were specifically designed for this study. Healthcare professionals completed the forms for the intervention arm only—at the intervention visit and during the 12 week treatment phase to collect details on sections of the booklet recommended to participants, and feedback on the booklet.The health economic analysis of this trial will be reported elsewhere.