Improvement in erectile function on vardenafil treatment correlates with treatment satisfaction in both patients and their partners.
OBJECTIVE
To evaluate the effect of vardenafil on both erectile function (EF) and treatment satisfaction (an aspect of quality of life) in men and their partners, as erectile dysfunction (ED) has a profound effect on patients' quality of life and that of their partners, and treatment for ED tends to be focused on improving functional measures of EF.


METHODS
For this randomized, double-blind, placebo-controlled trial, men with ED for >6 months, according to the USA National Institutes of Health Consensus Statement, were recruited. In all, 611 patients were randomized to treatment with either vardenafil (10 mg for 4 weeks, titrated to preferred dose, 5, 10 or 20 mg, during the next 8 weeks, and maintained at preferred dose for the following 14 weeks), or placebo.


RESULTS
At 18 weeks (primary endpoint), the mean improvement in the EF domain of International Index of EF (IIEF-EF) vs baseline was significantly greater with vardenafil than placebo (12.70 vs 1.69, P < 0.001). This was accompanied by significant benefits at 26 weeks and in various secondary variables relating to sexual satisfaction. Qualitative assessment of the treatment effect revealed three categories of importance to patients: effectiveness, confidence and quality of life. There were significant linear correlations between patients' EF and treatment satisfaction, and between patients' EF and their partners' treatment satisfaction.


CONCLUSIONS
Functional improvements in response to vardenafil treatment are significantly correlated with treatment satisfaction for both patients with ED and their partners. These findings apply to patients with a wide range of baseline characteristics.
Ralph
David
D
Middlesex Hospital, London, UK.
Eardley
Ian
I
Kell
Philip
P
Dean
John
J
Hackett
Geoff
G
Collins
Owen
O
Edwards
David
D
D000368:Aged; D000704:Analysis of Variance; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects; D010549:Personal Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D012747:Sexual Partners / Q000523:psychology; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride