A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

J Spinal Cord Med, 2008 · DOI: · Published: January 1, 2008

Simple Explanation

This study tested if sildenafil (Viagra) helps men with erectile dysfunction (ED) caused by spinal cord injury (SCI). The study compared sildenafil to a placebo to see if it improved their erections, sexual satisfaction, and overall quality of life. The study involved a crossover design where participants received both sildenafil and a placebo at different times. Researchers measured things like the success of sexual stimulation and intercourse, satisfaction with sexual life, and scores on questionnaires. The results showed that sildenafil was better than placebo at improving erectile function and satisfaction, especially in men with incomplete SCI. All patients who expressed a preference chose sildenafil over placebo. The drug was well-tolerated, but it did not have a measurable effect on the patient's overall quality of life.

Study Duration

16 weeks

Participants

50 men with ED attributable to SCI

Evidence Level

Level 1, Randomized, Double-Blind, Placebo-Controlled Crossover Study

Key Findings

1
Sildenafil significantly improved successful sexual stimulation and intercourse rates compared to placebo in men with ED and SCI.
2
Sildenafil was more effective in patients with incomplete SCI compared to those with complete SCI, showing significant improvements in several measures only in the incomplete SCI group.
3
All patients who expressed a preference chose sildenafil over placebo, highlighting its perceived benefit in treating ED related to SCI.

Research Summary

The study evaluated the efficacy and safety of sildenafil in men with erectile dysfunction (ED) associated with spinal cord injury (SCI). Sildenafil was found to be superior to placebo in improving erectile response, intercourse satisfaction, and overall sexual satisfaction, particularly in patients with incomplete SCI. The study concludes that sildenafil is an effective and well-tolerated treatment for ED in patients with SCI, with a strong preference for sildenafil over placebo among participants.

Practical Implications

Clinical Practice

Sildenafil can be considered as a first-line treatment option for men with ED and SCI, particularly those with incomplete injuries.

Patient Education

Patients with SCI should be informed about the potential benefits of sildenafil for improving erectile function and sexual satisfaction.

Future Research

Further research could investigate the long-term effects of sildenafil on sexual function and quality of life in men with SCI.

Study Limitations

1
The study did not record the proportions of patients with complete and incomplete injuries expressing a preference for sildenafil treatment.
2
The study found no significant change in QoL in patients with SCI receiving sildenafil, which contrasts with findings from some previous studies.
3
Analysis of vital signs was limited to the first cross-over phase only due to significant period/carryover effect.

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