Fingolimod, an oral medication for RRMS, has vago-mimetic effects on S1P1-receptors of cardiomyocytes and thus affects cardiovascular-autonomic modulation. S1P1-receptors occur ubiquitously and might be present in the bladder wall and smooth muscles. We hypothesize that Fingolimod influences these receptors and changes autonomic bladder-function via its parasympathomimetic or secondary autonomic effects.

24 RRMS-patients (mean age 39±11 years, 17 women), underwent uroflowmetry to measure voided-urine-volume, maximum-flow-rate, average-flow-rate, flow-time, time-to-maximum flow, and bladder ultrasonography (Solar-Uroflow™, Scanmaster™, MMS, Germany) to evaluate pre-voiding urine-volume and post-voiding residual urine-volume. These measurements and EDSS-scores were taken upon Fingolimod-initiation and after 12 months of Fingolimod-therapy (0.5mg/day). Bladder-values were compared to values assessed in 25 age- and sex-matched healthy controls (mean age 32±10 years, 13 women). Values assessed in patients at the two time-points and in controls were compared by ANOVA and post-hoc analysis, using t-tests for normally distributed data and Mann-Whitney-U-tests or Wilcoxon-tests for non-normally distributed data. Significance was set at p<0.05.

EDSS-scores remained unchanged. Voided-urine-volume, maximum-flow-rate, average-flow-rate, flow-time, and time-to-maximum flow, as well as pre-voiding urine-volume did not differ between controls and patients at the two measurement dates. Only post-voiding residual urine-volume was higher in patients than controls, but again did not differ within the patient-group at the two measurement dates.

Apart from slightly elevated post-voiding residual urine-volume in the RRMS-patients, the assessed parameters of bladder-function were similar between controls and patients at Fingolimod-initiation; this finding and the unchanged EDSS-scores suggest that any subsequent changes in bladder-function would more likely not be related to the RRMS but to Fingolimod. However, after 12 months of Fingolimod-therapy, bladder parameters remained unchanged in the RRMS-patients. These results suggest that Fingolimod has no clinically relevant effects on bladder-function.