Beste apotheek van Nederland

Intra-urethral Suppositories
Literature Search
Seven RCTs (in seven publications) were eligible and were included in the review. 299-305
Overview of Trials
Of the seven trials, 299-305 one reported only physiologic outcomes (timing and degree of
penile rigidity as measured by RigiScan) and no harms data. 305 Therefore, the remaining six trials
are described in more detail in this section. Of five studies, four assessed clinically relevant
efficacy outcome such as home sexual intercourse success 299,300,302,304 and one trial reported on
whether in-clinic erections were judged sufficient for intercourse. Of these six trials, 299-304 two
were cross-over design (n=345; range: 111-234 participants) and four were parallel design
(n=1726, range: 60-996 participants). No studies assessed therapies beyond 12 weeks. (Evidence
Table F-7, Appendix F)
Populations
Among the six trials reporting clinical efficacy and/or harms data, the mean age of the
subjects was 60.4 years (n=6 trials reporting). Racial characteristics were reported in only one
trial. ED etiology was of physiologic origin in the four studies reporting. Vascular disease and
diabetes were the most commonly reported underlying diseases. Mean duration of ED was
approximately 4 years. In four trials reporting, 56 percent of men reported previous treatment for
ED. No trials reported smoking status and body weight (e.g. body mass index), both risk factors
of ED.
Interventions
IU treatment interventions evaluated in eligible trials were alprostadil, prazosin, and the
combination of the two agents.
Among alprostadil interventions, one 3 month trial of IU alprostadil utilized a fixed dose of
1000µg . 301 Three trials utilized fixed doses of alprostadil from 125 to 1000µg administered at
home based on each subject’s response to various doses or a dose titration. 300,302,304 The home
treatment phases of these trials were 3 weeks and 3 months, 302,304 respectively. In another trial,
subjects received single in-clinic administrations of two of four alprostadil doses (125, 250, 500
and 1000µg) over a 2 to 4 week period. 303 In a sixth trial, subjects started at either 250 or 500µg
alprostadil for 4 weeks with subsequent dose titration so that final dose at 12 weeks ranged from
125 to 1000µg. 299 Pubic bands were allowed as optional adjunct therapies in two trials. 299,300
In one trial that evaluated a prazosin intervention, subjects received single in-clinic
administrations of two of four prazosin doses (250, 500, 1000 and 2000µg) over 2 - 4 week
period. 303
Finally, in the single trial that evaluated a combined alprostadil/prazosin intervention,
subjects received single in-clinic administrations of two of nine possible IU alprostadil/prazosin
dose combinations over a 2 to 4 week period. 303
Study Quality and Reporting
Information on pharmaceutical funding was reported to have been provided for five 299,300,302­
304 of the six trials. One trial 301 did not report a funding source. None of the trials reported
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