Gacci Mauro, Del Popolo Giulio, Macchiarella Angelo, Celso Maria, Vittori Gianni, Lapini Alberto, Serni Sergio, Sandner Peter, Maggi Mario, Carini Marco
Urology Unit, Department of Critical Care Medicine and Surgery, University of Florence, Florence, Italy.
J Urol. 2007 Nov;178(5):2040-3; discussion 2044. doi: 10.1016/j.juro.2007.07.048. Epub 2007 Sep 17.
We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment.
We performed a single center, randomized, double-blind, placebo controlled trial in 25 patients with spinal cord injury who had erectile dysfunction and micturition disorders. A baseline urodynamic test was performed as well as a second urodynamic test 1 to 3 hours after the administration of 20 mg vardenafil and placebo in 15 and 10 cases, respectively. In all patients standard oral oxybutynin administration was not discontinued. Statistical assessment included the 3 urodynamic parameters maximum detrusor pressure during voiding, maximum cystometric capacity and detrusor overactivity volume.
Placebo administration did not affect urodynamic parameters. After vardenafil administration maximum detrusor pressure was significantly decreased (59.3 vs 52.1 cm H(2)O, p <0.001) and maximum cystometric capacity considerably improved (233.5 vs 272 ml, p <0.001). The most dramatic variations were observed for detrusor overactivity volume (174 vs 218 ml, p <0.0001). In 7 patients with American Spinal Injury Association classification A and spinal cord injury above T6 we observed the most significant improvement in the evaluated urodynamic items, including maximum detrusor pressure 57 vs 52 cm H(2)O (p = 0.039), maximum cystometric capacity 253 vs 296 ml (p = 0.004) and detrusor overactivity volume 177 vs 229 ml (p = 0.003).
This trial demonstrates that in spinal cord injured patients a single 20 mg vardenafil administration achieved a significant decrease in maximum detrusor pressure, an improvement in maximum cystometric capacity and a remarkable increase in detrusor overactivity volume value.
我们评估了伐地那非给药后对接受奥昔布宁治疗的脊髓损伤男性患者尿动力学的影响。
我们在25例患有勃起功能障碍和排尿障碍的脊髓损伤患者中进行了一项单中心、随机、双盲、安慰剂对照试验。分别对15例和10例患者在服用20mg伐地那非和安慰剂后1至3小时进行了第二次尿动力学测试，同时进行了基线尿动力学测试。所有患者均未停止标准口服奥昔布宁给药。统计评估包括排尿时最大逼尿肌压力、最大膀胱测压容量和逼尿肌过度活动量这3项尿动力学参数。
服用安慰剂未影响尿动力学参数。服用伐地那非后，最大逼尿肌压力显著降低（59.3对52.1cm H₂O，p<0.001），最大膀胱测压容量显著改善（233.5对272ml，p<0.001）。逼尿肌过度活动量的变化最为显著（174对218ml，p<0.0001）。在7例美国脊髓损伤协会分级为A且脊髓损伤在T6以上的患者中，我们观察到评估的尿动力学指标改善最为显著，包括最大逼尿肌压力57对52cm H₂O（p = 0.039）、最大膀胱测压容量253对296ml（p = 0.004）和逼尿肌过度活动量177对229ml（p = 0.003）。
该试验表明，在脊髓损伤患者中，单次服用20mg伐地那非可使最大逼尿肌压力显著降低，最大膀胱测压容量得到改善，逼尿肌过度活动量值显著增加。
