Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Yonessi, M
(2005) 225
Funding
source: research
council of
Mazandaran
University of
Medical
Sciences, Sari,
Iran
N screened = 94
N randomized = 80
IG1, n = 40
CG, n = 40
ITT analysis used for
primary outcome: NR
Inclusion: ED
Exclusion: anatomical
defects of penis or other
sexual disorders; spinal cord
injury; major psychiatric
disorder; poorly controlled
diabetes; stroke; heart
attack within 6 mo; treatment
with organic nitrate; active
peptic ulcer disease;
migraine; vision disorders;
allergic rhinitis
Age, mean (range):
47.2 (26-63) vs. 50.8
(37-65) y
Race (%): NR
Co-morbidities
(unrelated to
disease): NR
Previous ED
treatment: NR
Smoking status: NR
Initial body weight:
NR
Concomitant
medications: NR
Duration of ED, mean
(range):
1.4 (0.6-2.8) vs. 1.5 (0.6­
3.0)
Underlying disease: NR
Psychogenic ED: 23 (57)
vs. 24 (60)
Physiologic ED: 17 (42)
vs. 16 (40)
Mixed ED: 0
IG: 1% sildenafil
topically to glans penis
+ placebo tablet
CG: placebo topically to
glans penis + sildenafil
tablet
IG1:
Dose: 0.5 g 1%
sildenafil gel + placebo
tablet
Duration: NR
Frequency: NR
Compliance (%): 100%
CG:
Dose: 100 mg oral
sildenafil and placebo
gel
Duration: NR
Frequency: NR
Compliance (%): 100%
Run In period: NR
Wash out period: NA
Primary outcome (EF):
Erection (complete, moderate, none)
and onset of erection, n (%):
Full erection: 5 (12.5) vs. 28 (70.0)
Moderate erection: 5 (12.5) vs. 6
(15.0)
None: 6 (15) vs. 30 (75.0)
Onset of erection (full E), mean (sd):
IG1: 7.4 (3.6) vs. 37.8 (14.9) min
Other outcomes assessed: NR
Withdrawals/drop-outs/loss to f/u:
0
WDAE, n (%): 0
TAE, n (%): pts with AE, 4 (10) vs. 4
(8) including headache in IG,
headache, dyspepsia, visual
disturbances in CG
SAE: 0
Ascertainment of outcomes
assessed: NR
F/u duration: up to 2
wk
Other: tablets were
taken 1 hr before sexual
activity
List of abbreviations: %=percent, ▲=increased, ▼=decreased, AE=adverse event, SAE=serious adverse event, BMI=body mass index, CC=controlled clinical trials,
CG=comparator/control group, ctrls=controls, DM=diabetes mellitus, E 1 IC=intracavernosal injection, ECG=electrocardiograms, ED=erectile dysfunction, EDV=end-diastolic velocity,
f/u=follow-up, FMD=flow mediated dilation, GAQ=global assessment question, GEQ=global efficacy question, grp=group/s, HbA1C=haemoglobin, hr=hour(s), hx=history,
IG=intervention group, IIEF= international index of erectile function (EF=erectile function, OF=orgasmic function, OS=overall satisfaction, SD=sexual desire), ITT=intent-to-treat (Y =
yes, N = no, NR = not reported), IU=intraurethral, kg=kilograms, lbs=pounds, LUTS=lower urinary tract symptoms, M=male, max=maximum, mo=month(s), NA=not applicable,
PADAM=partial androgen deficiency of the aging male, PgE 1 =Prostagladin, PRL=prolactin, PSA=prostate-specific antigen, RAU=rigidity activity unit, RCT=randomized control trial,
SBP=systolic blood pressure, sign.=significant; TAE=total adverse events, TAU=tumescence activity unit, vs.=versus, WDAE=withdrawals resulting from adverse events, wk=week(s),
yr=year(s).
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