Table 1. Randomised trials of oral phosphodiesterase type 5 inhibitors.
Authors | Year | Subjects | Treatment | Measure | Duration | Comment |
---|---|---|---|---|---|---|
Brock et al. 40 | 2003 | 440 | Placebo versus
vardenafil 10 mg, 20 mg |
IIEF-EF Diary
questions Global Assessment Question |
3 months | Benefit in severe erectile
dysfunction |
Montorsi et al. 35 | 2008 | 628 | Placebo versus
vardenafil (5 mg to 20 mg); nightly versus on-demand |
IIEF | 9 months,
2-month washout |
On-demand better than nightly,
better than placebo |
Padma-Nathan
et al. 41 |
2008 | 76 | Placebo versus
nightly sildenafil 50 mg, 100 mg |
IIEF | 36 weeks,
8-week washout |
Premature closing due to lack of
treatment effect. Results after 12 months of follow-up; 4% of placebo patients regained spontaneous erection compared with 27% in treatment arm |
Mulhall et al. 42 | 2013 | 298 | Avanafil on-demand
versus placebo |
Sexual encounter
profile (question 2) Sexual intercourse IIEF-EF |
3 months | |
Pavlovich et al. 36 | 2013 | 100 | Sildenafil; on-demand
with nightly placebo versus nightly with on-demand placebo |
Quality-of-life
assessments |
12 months,
1-month washout |
No significant differences found.
No sole placebo group |
Montorsi et al. 37 | 2014 | 423 | Placebo versus
tadalafil; daily versus on-demand |
IIEF-EF
Sexual encounter profile Penile length |
9 months,
6-week washout, 3-month open- label |
Penile length loss reduced by
4.1 mm Unassisted erectile function not improved after treatment cessation. No benefit to tadalafil versus placebo |
Moncada et al. 38 | 2015 | 423 | Placebo versus
tadalafil; daily versus on-demand |
IIEF-EF | 9 months,
6-week washout |
IIEF-EF improved most with daily
(29.5%, 23.9%,18.4% with IIEF ≥22) |
Kim et al. 39 | 2016 | 74 | On-demand sildenafil
with addition of either nightly sildenafil or placebo |
Rigiscan/IIEF | 12 months,
1-month washout |
No benefit of additional nightly
dosing to on-demand. No pure placebo group |
IIEF, International Index of Erectile Function; IIEF-EF, International Index of Erectile Function–erectile function domain.