OBJECTIVES: Tolterodine ER (TER) was granted reimbursement in neurogenic overactive bladder (OAB) patients by the Belgian Health Authorities in 2003 under the condition that an observational study be performed that confirms clinically significant improvements in health-related quality of life (HRQoL) in these patients. The results of the study are presented here. METHODS: A multicentre prospective non-interventional study was initiated in neurogenic OAB patients who discontinued oxybutinin treatment and were switched to TER. HRQoL data were collected through the symptom bother subscale of the OAB-q questionnaire which was administered at three different time points: before (M0) and after 3 (M3) and 12 Months or more (M12) of TER treatment. Efficacy and tolerability of TER treatment were also investigated. RESULTS: A total of 168 patient questionnaires of M3 and 93 of M12 were compared to baseline questionnaires (M0). The average age (±SD) was 59 (±16.9), patients were mainly female (70%). The mean total score (±SD) of the OAB-q subscale decreased from 29.13 (±9.12) to 18.16 (±7.53) at M3 and to 17.14 (±7.01) at M12 (p<0.001) compared to baseline oxybutinin treatment, exceeding the “Minimally Important Difference” of 10 points. All individual OAB-q symptom bother items showed an improvement with the highest impact on micturition frequency (27% at M3, 30% at M12) and uncomfortable/sudden urge to urinate (28% at M3, 30% at M12) (p<0.001). The % of patients reporting improvement in the treatment related adverse events such as memory, vertigo, constipation and dry mouth further increased from M3 to M12 compared to baseline oxybutinin treatment, with the most pronounced improvement for dry mouth: 58% at M3, 61% at M12. (p<0.001) CONCLUSION: The data presented in this real life study show that TER improved the Health Related Quality of Life of patients with a neurogenic OAB. Based upon these results the reimbursement of TER was maintained in Belgium.