Study design: Systemic reviewObjective:We carried out a systematic review and meta-analysis to assess the efficacy and safety of phosphodieterase-5 (PDE5) inhibitors on erectile dysfunction (ED) secondary to spinal cord injury (SCI).
Methods: A literature review was performed to identify all published randomized, double-blind, placebo-controlled trials of PDE5 inhibitors for treatment of ED secondary to SCI. The search included the following database: MEDLINE, EMBASE and the Cochrane Library. The outcomes and complications analyzed involved the Global Efficacy Question (GEQ), sexual encounter profile diary question 2 and 3 (SEP2 and SEP3) and adverse events. All statistical analysis was performed using Stata 12.0 software (Stata Corp., College Station, TX, USA).
Results: Six publications were used in analysis, including six randomized controlled trials that compared PDE5 inhibitors with placebo. Compared with placebo, PDE5 inhibitors were associated with significant improvements in GEQ (OR 11.997, 95% CI 8.073-17.830, P<0.0001), SEP2 (RR 1.847, 95% CI 1.561-2.185, P<0.0001) and SEP3 (RR 2.738, 95% CI 2.084-3.598, P<0.0001). Despite significant greater incidences of some adverse events observed (headache: RR 3.717, 95% CI 2.309-5.982, P<0.0001; flushing: RR 9.281, 95% CI 2.858-30.147, P<0.0001; gastrointestinal discomfort: RR 9.064, 95% CI 2.116-38.827, P=0.003), most adverse events were mild to moderate and transient.
Conclusions: This systematic review and meta-analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo, as measured by response to GEQ, SEP2, SEP3 and incidence of adverse events. PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI.