Beste apotheek van Nederland

C-190
Author
Funding
N; study design;
eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Wegner (1995) 198
Funding source:
NR
N screened = 60
N randomized = 40
(cross over)
IG1-3, n= 40
ITT analysis used for
primary outcome? NR
Inclusion: Pts with ED =>
6 mo duration
Exclusion: NR
Age, mean
(range):
53 (34-71) yr
Co-morbidities:
NR (see ‘Other’)
Previous ED
treatment: NR
Smoking status:
n=12
Body weight: NR
Other: alcohol
abuse (n=3), DM
(n=8)
Concomitant
medications: NR
Duration of ED: 3.2
y (6 mo – 7 y)
Underlying
disease: pelvic
surgery (n=3),
neurological causes
(n=2)
Psychogenic ED:
NR
Physiologic ED:
NR
Mixed ED: NR
Other: Diagnosis of
ED included testing
with PGE1, cause of
ED, sexual hx,
physical examination
IG1: Pg-E1
IG2: linsidomine
chlorhydrate (SIN-1)
IG3: SIN-1 + urapidil
IG1: Pg-E1
Dose: 20 μg
Duration: NR
Frequency: once
IG2: SIN-1
Dose: 1 mg
Duration: NR
Frequency: once
IG3: SIN-1 + urapidil
Dose:
1 mg (SIN-1), 10 mg
(urapidil)
Duration: NR
Frequency: once
Compliance all: NR
Run In period: NR
Wash out period: 3 d
Primary outcome results:
N pts with full response (grade 6)
(rigidity)/ rigid erection (grade 5), n (%)
IG1: 8 (20)/ 8 (20)
IG2: 0 (0)/ 3 (8)
IG3: 2 (5)/ 8 (20)
IG1 vs. IG2, p = 0.0001
IG2 vs. IG3, p = 0.0004
Other outcomes assessed: NR
Withdrawals/drop-outs/loss to f/u:
NR
WDAE: NR
TAE: NR
AE, n of events: 5 severe hypotension
in IG3; pain upon injection IG1=3;
IG2=1; IG3=3
SAE: NR
Ascertainment of outcomes
assessed: inspection and palpation (0=
no response; 5= full tumescence; 6= full
tumescence with rigidity)
F/u duration: 3 d
(assessed 5, 10, 20, 30
min after injection)
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).