Beste apotheek van Nederland

Author
Funding
N; study design; eligibility
Participants
characteristics
Diagnosis details Intervention Outcomes
Williams (1998)
212
Funding
source: Grant
from VIVUS Inc.
Manufacturer of
MUSE
(Alprostadil
(PGE 1 ) in
transurethral
route)
N screened = 249
N randomized = 159 (64%
of screened pts who
achieved erection adequate
for intercourse on test dose)
IG, n = 78
CG, n = 81
ITT analysis used for
primary outcome: ITT
efficacy 44%
Inclusion: men 18 y or older
with primary organic ED 3
mo or longer in duration,
inability to achieve erection
for intercourse on all
attempts for 3 mo before
study, stable, heterosexual,
monogamous relationship,
willing to have intercourse
4/mo + use contraception
Exclusion: NR
Data reported for IG vs. CG
Age, mean
(range):
57.3 (25-78) y vs.
57.3 (26-77) y
Co-morbidities:
NR
Previous ED
treatment, (%):
51 vs. 54
(constrictive
bands, IC,
vacuum,
counseling)
Smoking status:
NR
Body weight: NR
Concomitant
medications: NR
Duration of ED,
mean (range):
59.6 (3-644) vs. 63.3
(4-417) mo
Underlying
disease: NR
Psychogenic ED:
NR
Physiologic ED:
Vascular disease:
33% vs. 41%
Diabetes 18% vs.
15%
Surgery/trauma:
24% vs. 21%
Other organic
(includes; alcohol or
tobacco use;
neurological
diseases;
medication adverse
reaction): 24% vs.
24%
Mixed ED: NR
IG1: Alprostadil (PgE1)
transuretrhal pellet as
per protocol
CG: Placebo
IG1:
Dose: Escalating dose
of 125, 250, 500 or
1000 μg
Duration: 3 mo
Frequency: at least
1/mo
Compliance: 53 (68%)
CG:
Dose: Placebo
Duration: 3 mo
Frequency: as IG 1/mo
Compliance: 64 (79%)
Run In period: 3 mo
Wash out period: NA
F/u duration:
3 mo
Other: Final patient
selected dose
distribution (μg), n (%):
1000 μg =103 (65%)
500 μg= 27 (17%)
250 μg =21 (13%)
125 μg =5 (5%)
Primary outcome results:
EAS, score ≥ 4: in all pts, 159 (64%)
Intercourse ≥ once during 3 mo, n (%):
46(69) vs. 8/73 (11%), p<0.001
Intercourse/ total injections: 390/ 763
(51) vs. 46/611 (7.5) CG
Other outcomes assessed: NA
Withdrawals/drop-outs/loss to f/u, n
(%): 42 (26%) [n=25 vs. n=17]
WDAE: 4
TAE: self reported AEs, n (%):
Urogenital pain/ burning: 5 (6) vs. 0
Penile pain: 4 (5) vs. 1 (1)
Testicular pain: 2 (3) vs. 0
Urethral bleeding/spotting: 1 (1) vs. 1
(1)
Urinary tract infection: 0 vs. 0
Prolonged erection < 5 hr: 1 (1) two
events vs. 0
Priapism (≥ 6 hr)= firbrosis=
hypotension: 0 vs. 0
Dizziness: 2 (3) vs. 0
SAE: 0
Ascertainment of outcomes
assessed: Erectile Assessment Scale
(1=no response to 5=rigid erection)
Comfort with therapy, intercourse rate,
and AE by diary/self report
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).
C-201