Quality of life effects of alprostadil therapy for erectile dysfunction: results of a trial in Europe and South Africa.
OBJECTIVE
Quality of life (QOL) data were used to evaluate the effects of self-administered intracavernosal injection of alprostadil for erectile dysfunction, when used for up to 18 months during a 13 country Phase III clinical trial.


METHODS
The Duke Health Profile was used to measure patients' physical and psychosocial QOL at baseline, 3, 6, 12 and 18 months. Changes from baseline were measured using paired t-tests, with additional analyses by cause of dysfunction, starting dosage, and prior treatment.


RESULTS
Patients displayed significant improvements in mental and social health and self-esteem at six months (P < 0.01, n = 570), with greater improvements at 12 and 18 months. Anxiety and depression measures also improved significantly at 12 and 18 months, as did the summary general health score. Worse pain scores were observed in the first year but not at 18 months. Those with a starting dosage of 10-20 micrograms, those with psychogenic causes of dysfunction, and those with no prior treatment for erectile dysfunction generally showed the greatest improvements.


CONCLUSIONS
In this study, the clinical improvements in erectile function due to intracavernosal alprostadil therapy were complemented by QOL improvements, particularly in the mental health, of many patients.
Willke
R J
RJ
Pharmacia & Upjohn, Kalamazoo, Michigan 49001, USA.
Yen
W
W
Parkerson
G R
GR
Linet
O I
OI
Erder
M H
MH
Glick
H A
HA
D000328:Adult; D000368:Aged; D000527:Alprostadil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety; D003863:Depression; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D005060:Europe; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain; D011446:Prospective Studies; D011788:Quality of Life; D012646:Self Administration; D012649:Self Concept; D013019:South Africa; D013997:Time Factors; D014665:Vasodilator Agents / Q000627:therapeutic use*
D014665:Vasodilator Agents; D000527:Alprostadil