Purpose: Now that individuals with spina bifida live well into adulthood er
ectile dysfunction has become a recognized associated medical disorder. To
our knowledge no study has dealt specifically with treatment of erectile dy
sfunction in men with spina bifida. Therefore, we conducted a prospective,
blinded, randomized, placebo controlled, dose escalation, crossover study t
o determine the ability to treat erectile dysfunction in men with spina bif
ida with sildenafil citrate.
Materials and Methods: Erectile dysfunction was diagnosed in 15 men 19 to 3
5 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 rug. sild
enafil and 2 identical looking sets of corresponding placebos I hour before
planned sexual activity. Efficacy was assessed by the effect of treatment
compared to baseline, that is before treatment, on rating of erections (sco
red from 0 to 10), duration of erections, frequency of erections based on r
esponse to question 1 (scored from 0 to 5) of the International Index of Er
ectile Function and confidence to obtain an erection based on response to q
uestion 15 (scored from 1 to 5) of the International Index of Erectile Func
tion.
Results: Improved erectile function was reported while on sildenafil by 12
(80%) men compared to baseline and placebos. There was a significant dose d
ependent improvement of erectile function with both 25 and 50 mg. sildenafi
l 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 freque
ncy of erections increased by 61% and 96%, and mean level of confidence inc
reased by 33% and 63%, respectively. Furthermore, 50 mg. sildenafil provide
d greater improvement in all 4 parameters compared to 25 mg. The placebo re
sults were not significantly different compared to baseline for any of the
parameters.
Conclusions: Erectile dysfunction in patients with spina bifida is a medica
lly treatable condition. Sildenafil is effective in this patient population
and improves level of sexual confidence.