Vardenafil improves urodynamic parameters in men with spinal cord injury: results from a single dose, pilot study.
OBJECTIVE
We assessed urodynamic changes after vardenafil administration in spinal cord injured male patients on oxybutynin treatment.


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 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).


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.
Gacci
Mauro
M
Urology Unit, Department of Critical Care Medicine and Surgery, University of Florence, Florence, Italy.
Del Popolo
Giulio
G
Macchiarella
Angelo
A
Celso
Maria
M
Vittori
Gianni
G
Lapini
Alberto
A
Serni
Sergio
S
Sandner
Peter
P
Maggi
Mario
M
Carini
Marco
M
D000284:Administration, Oral; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology*; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008333:Mandelic Acids / Q000008:administration & dosage; D008875:Middle Aged; D010276:Parasympatholytics / Q000008:administration & dosage; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage*; D012189:Retrospective Studies; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000503:physiopathology; D013450:Sulfones / Q000008:administration & dosage; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D014555:Urination Disorders / Q000188:drug therapy / Q000209:etiology / Q000503:physiopathology*; D014563:Urodynamics / Q000187:drug effects*; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D008333:Mandelic Acids; D010276:Parasympatholytics; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; C005419:oxybutynin