Beste apotheek van Nederland

Injection Treatments - Intracavernosal Injection
Literature Search
Forty-two trials (in 43 publications) met eligibility criteria as randomized trials of
intracavernosal injection (IC) therapy for treatment of men diagnosed with ED. 119,172,255-280,280-294
One trial was reported in two publications 261,276 and one publication described two trials (Aversa
et al. 1996; studies: a and b). 267
Overview of Trials
Among the 42 unique trials, 32 used a crossover design (n = 1957; range: 7 to 240 subjects)
and 10 a parallel design (n = 1074, range: 30 to 296 subjects).
Populations
ED was primarily of physiologic origin (58 percent). Amongst ED patients, vascular disease
and diabetes were the most commonly reported underlying conditions. Three trials exclusively
enrolled men with previous radical prostatectomy or cystectomy (n = 159 subjects). Only eight
trials reported smoking status, two trials ethnicity, and none reported body weight (e.g. body
mass index).
Interventions
IC alprostadil (PGE 1 ) was evaluated alone or in combination with numerous other
pharmacologic agents. One specific alprostadil combination (alprostadil plus papaverine plus
phentolamine) was also tested alone or in combination with other pharmacologic agents. Other
types of evaluated IC were papaverine; papaverine plus phentolamine, with or without additional
sexual counseling; moxisylate; sodium nitroprusside; linsidomine; linsidomine plus urapidil;
papaverine plus sildenafil; and vasoactive intestinal peptide plus phentolamine. For a full
description of treatment interventions in these individual trials refer to Evidence Table F-5
(Appendix F).
Study Quality and Reporting
Information on pharmaceutical funding was provided for nine trials. Only three studies
specifically reported the use of an intention-to-treat analysis. None of the trials reported methods
of allocation concealment. Study withdrawals, drop-outs or lost to followup were reported in 33
trials and were 13 percent (16 percent in crossover studies and 6 percent for parallel studies). The
majority of the trials were considered to be of low quality with total Jadad score < 3. Only six of
the 43 trials received a score of four, and none received a score of five. Twenty-nine trials
received a score of two or less. In addition, many studies reported physiologic (e.g. degree or
duration of penile rigidity) rather than clinically validated outcomes (IIEF, SEP, GAQ–Q1).No
study assessed therapies beyond 12 weeks.
Outcomes
Many of the 42 trials measured only physiologic efficacy outcomes (e.g. penile rigidity). Of
the clinically relevant outcomes, more commonly reported were quality of erections achieved at
home, without regard to whether the patient was able to achieve successful sexual intercourse,
(e.g. “improvement” in erections, “full response,” full erection,” or “grade 4 or 5 erections”).
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