VARDENAFIL IMPROVES BLADDER COMPLIANCE IN MEN WITH SPINAL CORD INJURY: RESULTS FROM A SINGLE DOSE, PILOT STUDY

Introduction & Objectives: To evaluate, by urodynamic assessment, bladder compliance changes after a single 20 mg vardenafil administration in male Spinal Cord Injured (SCI) patients under oxybutynin treatment. Material & Methods: We performed a single centre, randomized, double-blind, placebo controlled trial on 25 SCI patients with erectile dysfunction and micturition disorders. A baseline urodynamic test, and, later, a second urodynamic test 1 to 3 hours after administration of vardenafil 20 mg (15 cases) or placebo (10 cases) were performed. In all patients, standard oral oxybutynin administration was not discontinued. Urodynamic assessment included maximum cystometric capacity (MCC) and maximum detrusor pressure during voiding (MDP) to calculate bladder compliance. Results: Placebo administration did not significantly affect either MDP and MCC, with no change in compliance. After vardenafil administration, maximum cystometric capacity was considerably improved (233.5 vs. 272.0 ml, p<0.001), while maximum detrusor pressure during voiding was significantly reduced (59.3 vs. 52.1 cmH2O, p<0.001). These changes generate a remarkable improvement in bladder compliance (4.3 vs.6.2 ml/cmH2O, p=0.003). Only 1 patients retained the same bladder compliance after vardenafil administration (4 ml/cmH2O), while no patients reported a compliance decline. Conclusions: We demonstrated that, in SCI patients, a single 20mg vardenafil administration achieves a remarkable increase of bladder compliance. This trial reveals, for the first time, a urodynamically recordable activity of PDE5I on human bladder. Further studies are necessary to investigate the potential role of PDE5I for neurogenic overactive bladder.