Objectives: The aim of this study was to assess efficacy and safety of association of duloxetine and rehabilitation compared with rehabilitation alone in men with SUI after radical retropubic prostatectomy (RRP), and to compare continence rate even after planned duloxetine suspension.
Methods: After catheter removal, 112 patients were randomized to receive rehabilitation and duloxetine (group A) or rehabilitation alone (group B), for 16 wk.
Inclusion criteria: postprostatectomy SUI with daily incontinent episodes frequency (IEF) of four or greater. After 16 wk both groups suspended duloxetine/placebo and continued rehabilitation. All patients completed incontinence quality of life (I-QoL) questionnaire and bladder diary. Wilcoxon test was used to analyse changes in IEF and in I-QoL score; Fisher exact test was used to compare continent patients between the groups.
Results: Adverse events for duloxetine was 15.2%. 102 men completed the study. There was a significant decrease in pad use in group A. After 16 wk, 39 patients versus 27 were dry (p=0.007). At 20 wk, 4 wk after planned interruption of duloxetine, we observed a U-turn, 23 patients were completely dry in group A versus 38 in group B (p=0.008). Whereas, after 24 wk, 31 in group A versus 41 in group B were dry (p=0.08). The decrease in IEF and improvements in I-QoL scores were significantly greater in group A for the first 16 wk.
Conclusions: The data suggest that combination therapy might provide another treatment option for SUI in men that might increase the percentage of early postsurgery continence.