1. Vardenafil Improves Urodynamic Parameters in Men With Spinal Cord Injury: Results From a Single Dose, Pilot Study.
- Author
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Gacci, Mauro, Del Popolo, Giulio, Macchiarella, Angelo, Celso, Maria, Vittori, Gianni, Lapini, Alberto, Serni, Sergio, Sandner, Peter, Maggi, Mario, and Carini, Marco
- Subjects
SPINAL cord ,CENTRAL nervous system ,IMPOTENCE ,SEXUAL dysfunction - Abstract
Purpose: We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment. Materials and Methods: 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. Results: 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 H2 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). Conclusions: 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. [Copyright &y& Elsevier]- Published
- 2007
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