Vardenafil improves urodynamic parameters in men with spinal cord injury: results from a single dose, pilot study.

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 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.

• Authors: Mauro Gacci, Giulio Del Popolo, Angelo Macchiarella, Maria Celso, Gianni Vittori, Alberto Lapini, Sergio Serni, Peter Sandner, Mario Maggi, Marco Carini
• Journal: The Journal of urology (J Urol) Vol. 178 Issue 5 Pg. 2040-3; discussion 2044 (Nov 2007) ISSN: 0022-5347 [Print] United States
• PMID: 17869296 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Imidazoles
• Mandelic Acids
• Parasympatholytics
• Phosphodiesterase Inhibitors
• Piperazines
• Sulfones
• Triazines
• Vardenafil Dihydrochloride
• oxybutynin

Topics

• Administration, Oral
• Adult
• Dose-Response Relationship, Drug
• Double-Blind Method
• Erectile Dysfunction (drug therapy, etiology, physiopathology)
• Follow-Up Studies
• Humans
• Imidazoles (administration & dosage)
• Male
• Mandelic Acids (administration & dosage)
• Middle Aged
• Parasympatholytics (administration & dosage)
• Phosphodiesterase Inhibitors (administration & dosage)
• Pilot Projects
• Piperazines (administration & dosage)
• Retrospective Studies
• Spinal Cord Injuries (drug therapy, physiopathology)
• Sulfones (administration & dosage)
• Treatment Outcome
• Triazines (administration & dosage)
• Urination Disorders (drug therapy, etiology, physiopathology)
• Urodynamics (drug effects)
• Vardenafil Dihydrochloride