Palmer J S, Kaplan W E, Firlit C F
Division of Urology, Children's Memorial Hospital, Northwestern University Medical School, Chicago, Illinois, USA.
J Urol. 2000 Sep;164(3 Pt 2):958-61. doi: 10.1097/00005392-200009020-00009.
Now that individuals with spina bifida live well into adulthood erectile dysfunction has become a recognized associated medical disorder. To our knowledge no study has dealt specifically with treatment of erectile dysfunction in men with spina bifida. Therefore, we conducted a prospective, blinded, randomized, placebo controlled, dose escalation, crossover study to determine the ability to treat erectile dysfunction in men with spina bifida with sildenafil citrate.
Erectile dysfunction was diagnosed in 15 men 19 to 35 years old with spina bifida who were assigned to take 4 sets of tablets, 5 tablets per set, in a random order. All patients took 25 and 50 mg. sildenafil and 2 identical looking sets of corresponding placebos 1 hour before planned sexual activity. Efficacy was assessed by the effect of treatment compared to baseline, that is before treatment, on rating of erections (scored from 0 to 10), duration of erections, frequency of erections based on response to question 1 (scored from 0 to 5) of the International Index of Erectile Function and confidence to obtain an erection based on response to question 15 (scored from 1 to 5) of the International Index of Erectile Function.
Improved erectile function was reported while on sildenafil by 12 (80%) men compared to baseline and placebos. There was a significant dose dependent improvement of erectile function with both 25 and 50 mg. sildenafil compared to baseline (p <0.05), as mean erectile score increased by 50% and 88%, mean duration of erections increased by 192% and 266%, mean frequency of erections increased by 61% and 96%, and mean level of confidence increased by 33% and 63%, respectively. Furthermore, 50 mg. sildenafil provided greater improvement in all 4 parameters compared to 25 mg. The placebo results were not significantly different compared to baseline for any of the parameters.
Erectile dysfunction in patients with spina bifida is a medically treatable condition. Sildenafil is effective in this patient population and improves level of sexual confidence.