Long-term intermittent catheterization: Safety and outcomes from a prospective observational study.

Objectives: The aim of this study was to evaluate long-term safety, urological complication rates and quality of life (QoL) associated with urethral intermittent catheterization (IC) over a 5-year follow-up in adult, established, experienced subjects with longstanding IC use. Patients and Methods: Prospective, noninterventional, observational cohort study at three European sites. Adults (≥18 years) performing urethral IC with LoFric™ catheters for ≥6 years prior to enrolment were followed for 5 years. Outcomes included symptomatic urinary tract infections (UTIs), urethral strictures, bladder stones, prostatitis, epididymitis, patient-reported outcomes (PROs) and perception of catheters and IC. QoL, including pain and discomfort, anxiousness and depression, self-care and performing usual activities, was evaluated through the EQ 5DL questionnaire. Results: Ninety-eight participants were enrolled (April 2015-August 2018); 49 completed 5-year follow-up (PP). Median age at inclusion was 61 years; 69% were male. Median follow-up was 5 years; mean prior LoFric use was 13 years (range 6-30). Neurological conditions comprised 51% of underlying aetiologies. Across 5 years, there were no significant changes in UTI frequency, other urological complications, EQ-5D tariff, or PRO ratings. At baseline, 59% (PP) reported ≥1 UTI in the prior 12 months versus 55% at Year 5 ( Conclusions: In adults with more than a decade of prior IC experience, continued use of hydrophilic LoFric catheters over an additional 5 years was associated with unchanged complication rates and stable QoL and PROs, supporting the long-term safety of IC as a bladder management strategy.