Ten years of phosphodiesterase type 5 inhibitors in spinal cord injured patients.
BACKGROUND
The majority of men with spinal cord injury (SCI) require chronic treatment for erectile dysfunction (ED), but most of them, prior to taking phosphodiesterase type 5 (PDE5) inhibitors, stopped therapy due to side-effects or low compliance rate.


OBJECTIVE
Analysis of literature on oral PDE5 inhibitors in individuals with SCI and ED in order to evaluate how much their release changed the management of ED in SCI subjects and what remains to be seen of their potential or limits.


METHODS
Questionnaires on sexual function.


METHODS
18 internationally published clinical studies that enrolled SCI males treated with at least one of the PDE5 inhibitors were analyzed.


RESULTS
The small numbers of papers with large and diverse outcome measures did not consent a meta-analysis of treatment results. 705 used sildenafil, 305 vardenafil and 224 tadalafil. Median age was less than 40 years. Only 1 study excluded tetraplegic individuals. For measures of ED evaluated, 11 out of 13 studies reported a significant statistical improvement with PDE5 inhibitors versus placebo or erectile baseline (P < 0.01, or p < 0.005). The most frequent predicable factor for the therapeutic success of PDE5 inhibitors was upper motoneuron lesion. Statistical impact on ejaculation success rates was shown in at least one paper for all PDE5 inhibitors (p < 0.05). Overall, 15 patients, (7 using sildenafil), discontinued the therapies due to drawbacks. Only 1 sildenafil study reported a follow-up maximum of 24 months.


CONCLUSIONS
Literature suggests that all oral PDE5 inhibitors represent a safe and effective treatment option for ED caused by SCI. Further research is needed on head-to-head comparative trials and SCI patient preference for these drugs; their impact on ejaculation and orgasm function, their early use after SCI for increasing the recovery rate of a spontaneous erection, and their effectiveness and tolerability in the long-term are still to be investigated.
Lombardi
Giuseppe
G
Spinal Cord Department, Neurourology, Via Largo Palagi 1, 50139 Careggi University Hospital, Florence, Italy. giuseppelombardi@interfree.it
Macchiarella
Angelo
A
Cecconi
Filippo
F
Del Popolo
Giulio
G
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D002243:Carbolines / Q000008:administration & dosage; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage; D011687:Purines / Q000008:administration & dosage; D012098:Reproduction / Q000187:drug effects; D000068677:Sildenafil Citrate; D013119:Spinal Cord Injuries / Q000150:complications*; D013450:Sulfones / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D000068581:Tadalafil; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride; D055815:Young Adult
D002243:Carbolines; D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; D000068581:Tadalafil; D000068677:Sildenafil Citrate