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Duration of Erection – A New Efficacy Parameter of Erectile Dysfunction?
Duration of Erection – Lessons from vardenafil treatment compared with placebo (see Table 3). Vardenafil
Clinical Studies was well tolerated in this study, with no treatment-emergent serious
A double-blind, placebo-controlled trial randomised men (18–64 adverse events deemed to be drug-related.
years of age) with ED for more than six months and dyslipidaemia
treated with a statin for ≥3 months to receive either on-demand The results of these studies indicate that duration of erection represents
flexible-dose vardenafil or placebo for 12 weeks after an initial a novel efficacy measure for evaluating PDE-5 inhibitors, and could be
four-week unmedicated run-in period.
13
The primary measures of used as a predictor or efficacy measure of sexual performance in
SEP2 and SEP3 were assessed at week 12, while another primary couples affected by ED. With regard to the method of measuring
efficacy measure, IIEF-EF, was assessed at week 12/LOCF. duration, the stopwatch method was shown to be reliable and capable
Significant improvements were observed in the rate of successful of complementing traditional self-assessment efficacy methods for
penetration, the rate of successful intercourse completion and evaluating the efficacy of PDE-5 inhibitors. Vardenafil has been shown to
erectile function in the vardenafil group compared with the placebo significantly improve the duration of erection in men with ED
13,14
and the
group (see Table 2). Stopwatch-assessed duration of erection was sexual QoL in both members of a couple affected by ED.
13,14
used as a secondary efficacy measure in this study.
Conclusions and the Implications of the
Over the 12-week treatment period, there was a nearly three-fold New Data on Duration of Erection
longer duration of erection leading to successful intercourse in the ED has a significant impact on the sexual QoL of affected couples.
vardenafil group compared with placebo (LS mean duration of While the hardness of an erection is important to the sexual
erection: 10.00 versus 3.38 minutes, respectively; p<0.001). The performance, duration of erection has also been shown to be quite
change from baseline in LS mean duration of erection was also important, with improved duration associated with greater sexual
nearly three-fold greater for the vardenafil group versus placebo pleasure and sexual QoL. Duration of erection has been investigated
(9.46 versus 2.84 minutes, respectively; p<0.001). Furthermore, as a new efficacy measure for evaluating the efficacy of PDE-5
there were significant improvements in duration of erection in the inhibitors. It has been shown to be a valuable efficacy measure, with
vardenafil group compared with placebo, regardless of whether the the stopwatch-assessed method of measurement being quite reliable.
patients had dyslipidaemia with or without underlying hypertension Furthermore, vardenafil has been shown to substantially improve the
or diabetes. This study has confirmed that vardenafil is safe and duration of erection in men with ED, and the sexual QoL of couples
well-tolerated in men with ED and underlying metabolic and affected by ED. The new data on the duration of erection are of
cardiovascular conditions. importance to both patients and urologists. The message to the
patients is that increasing duration of erection can improve sexual
To further investigate stopwatch-assessed duration of erection as a pleasure and that there are treatment options available that can
measure of efficacy, the ENDURANCE study utilised the parameter as increase the duration in men with ED, thereby improving the sexual
a primary efficacy measure.
14
This multicentre, double-blind, QoL of the couple. The promising data are expected to encourage
placebo-controlled, cross-over study (n=201) randomised men more men with ED to seek treatment. The message to urologists is
(18–64 years of age) with ED for more than six months to fixed-dose that it is the combination of hardness and a greater duration of
vardenafil 10mg or placebo for four weeks after an initial four-week erection that will allow both members of a couple affected by ED to
unmedicated run-in period. This four-week randomisation phase was have a satisfactory sexual life; therefore, treatment strategies for ED
followed by one week of agent washout and a four-week cross-over should increasingly focus on duration of erection. n
phase where treatment schedules in the two groups were switched
with each other. In the vardenafil group there was a nearly two- to
Ridwan Shabsigh is Director of the Division of Urology
three-fold longer duration of erection leading to successful
at Maimonides Medical Center in New York and a
intercourse compared with placebo (LS mean duration of erection: Professor of Clinical Urology at the College of
12.81 versus 5.45 minutes, respectively; p<0.001).
Physicians and Surgeons of Columbia University. He is a
Fellow of the American College of Surgeons (ACS), a
diplomate of the American Board of Urology and an
The change from baseline in LS mean duration of erection was also active member of several professional organisations.
significantly greater for the vardenafil group compared to placebo
Professor Shabsigh’s research has focused on the
treatment of sexual dysfunctions, as well as the role of
(12.18 versus 4.82 minutes, respectively; p<0.001). Over the four-
sexual dysfunction in hypertension, depression, hypogonadism, diabetes and
week treatment period in patients receiving both treatments, the metabolic syndrome. He has served as a principal investigator for efficacy and safety
secondary efficacy measures IIEF-EF, SEP2 and SEP3 also showed
trials on a range of drugs and medical devices for the treatment of erectile
dysfunction, premature ejaculation, hypogonadism and female sexual dysfunction.
significant improvements in erectile function, rates of successful
penetration and successful intercourse completion following
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EUROPEAN UROLOGICAL REVIEW 59
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