Beste apotheek van Nederland

C-153
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Colli (1996)
162
Funding source:
N screened = NR
N randomized = 45
(cross over)
IG1-3/ CG, n= 45
ITT analysis used for
primary outcome? No
Inclusion: Men aged 18­
65 yrs with ED of probable
vascular, neurological
and/or psychological
origin of => 6 mo duration
Exclusion: penile
anatomical deformation,
priapism or corporeal
fibrosis, endocrine ED
(serum testosterone < 120
ng/dl and PRL > 20
ng/ml), sickle cell anemia,
hematologic diseases,
systematic or psychiatric
dx of recent onset,
uncontrolled DM (fasting
blood sugar > 300 mg/dl),
uncontrolled hypertension
(systolic > 150 and
diastolic > 100 mmHg),
hypotension (systolic <
100 mmHg), smokers (>
40 cigarettes/d), present
use of PgE1
Age, mean (sd):
NR (NR);
20% (< 40 yrs),
33.3% (40-49 yrs),
37.7% (50-59 yrs),
8.8% (=> 60 yrs)
Race (%): NR
Co-morbidities:
NR
Previous ED
treatment: NR
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED (yr):
<= 1 yr (22.2%)
1-2 yrs (31.1%)
2-5 yrs (22.2%)
5-10 yrs (20%)
> 10 yrs (4.4%)
Underlying disease
(diagnosis) (N or %
of diseased/ grp):
diabetes 2 (4.4%)
Psychogenic ED:
24 (53.3%)
Physiologic ED:
vascular 12 (26.6%),
neurologic 2 (4.4%)
Mixed ED: Mixed 5
(11.1%)
IG1-3: PgE1
(alprostadil)
CG: placebo
IG1: PgE1
Dose: 5 μg (IG1), 10 μg
(IG2), 20 μg (IG3)
Duration: NA
Frequency: one/wk
Compliance (%): NR
CG: placebo
Dose: NR
Duration: NA
Frequency: one/wk
Compliance (%): NR
Run In period: NR
Wash out period: 1 wk
F/u duration: NR
(assessments done 5­
120 min after injection)
Primary outcome results:
IG1 vs. IG2 vs. IG3 vs. CG
‘Full’ erection as assessed by clinical
manual palpation (n): 12 vs. 23 vs. 4 vs.
0, p < 0.001 (likelihood ratio test for the
treatment effect)
‘No’ erection as assessed by clinical
manual palpation (n): 11 vs. 5 vs. 2 vs.
41, p < 0.001 (likelihood ratio test for
the treatment effect)
‘Excellent’ erection- pts assessment (n):
5 vs. 9 vs. NR, vs. 0, p < 0.001
(likelihood ratio test for the treatment
effect)
‘Full’ erection (70% or more rigidity at
tip or base for 10 min), n: 17 vs. 25 vs.
7 vs. 0, p < 0.001 (likelihood ratio test
for rigidity)
Other outcomes assessed: latency of
erection
Withdrawals/drop-outs/loss to f/u NR
WDAE: NR
TAE: NR; AE reported as treatmentrelated
n=3 (IG2) vs. n=1 (IG1)
SAE: NR
Ascertainment of outcomes
assessed: manual palpation; RigiScan,
questionnaires