Treatment of erectile dysfunction (3) |
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After the International Journal of Impotence Research (2002),
volume 14, 226 - 245
The
International Index of Erectile Function has been
used more and more with trials of treatments for erectile dysfunction which do
not involve Viagra. The possibility has been raised that the IIEF might have
evolved with greater sensitivity to the effect of Viagra than the effect of
other treatments on erectile dysfunction - after all, it was developed
specifically in response to the need for a standard tool for assessing the
effects of Viagra on erectile dysfunction. As will become clear, the
International Index of Erectile Function shows regularly predictable and
completely reliable sensitivity to the treatment of erectile problems with other
agents, including tadalafil and vardenafil, and the now
ratheyr older but still popular intracavernosal injections. All of these other treatments have
been assessed with the use of the International Index of Erectile Function as a
primary measuring tool and outcome assessment aid. Unfortunately, none of these
trials are directly comparable with each other since they were not conducted as
head to head comparative studies - although the IIEF does give some measure of
comparison. Researchers were attempting to study the pattern of
International Index of Erectile Function scores which were derived from these
clinical trials with a view to confirming the robustness and responsiveness of the
IIEF to various treatment strategies. Tadalafil is better known as Cialis, a powerful and selective PDE-5 inhibitor which
works in a similar way to Viagra. Padma-Nathan
et al demonstrated the effectiveness and safety of Cialis in a study
conducted on 179 men with mild or moderate symptoms of erectile dysfunction (but
excluding men who had undergone
radical prostatectomy or who had diabetes). These men received of four
different doses of the drug or a placebo in four groups for the three weeks'
duration of treatment. At the start of the trial, mean scores were 2.8,
2.2, and 13.7 for questions 3, 4, and the erectile function domain. After treatment,
the question 3 and question 4
scores ranged from 2.5 and 2.4 among men taking the placebo to 4.2 and 4.0
among men receiving the highest treatment dose of 25 mg.
The erectile function domain scores varied from 14.7 among men receiving
the placebo to 24.2 among men receiving the 25 mg dose. All treatment differences were highly significant
at the 1 in a 1000 level. This study also required men to keep a diary, and their
comments and records backed up observed changes in the International Index
of Erectile Function. When the men's partners kept diaries, there was additional corroboration of
the recorded International Index of Erectile Function changes. There was a high
degree of consistency with results from the Viagra trials, although it is not
possible to do a direct head-to-head comparison. Porst et al reported a study conducted on vardenafil,
the third potent PDE-5 inhibitor, in almost six hundred men with erectile
dysfunction of varying origin. The men received doses of either a placebo or 5, 10 or 20 mg of vardenafil
for the treatment duration. At the start of the trial, the average (mean) scores
for all the men were 2.5 for question 3, 2.1 for question 4 and 14.0 for the
erectile function domain. The study excluded men who had previously taken Viagra with no
effect or those who had undergone radical prostatectomy or who had diabetes. The
changes recorded on the IIEF were as follows: for men on the highest dose the
scores were for question 3 = 4.0, for question 4 = 3.8, and for the erectile
function domain = 22.8. On the placebo, the corresponding numbers were 2.5,
2.0 and 15.6. Once again, the reports in the men's diaries were consistent
with scores achieved on the International Index of Erectile Function. Oral phentolamine (otherwise known as Vasomax) is an alpha-1 and alpha-2 adrenergic antagonist,
used as a treatment for erectile dysfunction. It has previously been
administered as an injection in combination
with papaverine, and is now coming under scrutiny as an orally-administered
drug for the treatment of erectile dysfunction. Two large-scale trials showed significant
improvements of erectile function when comparing drug and placebo in
International Index of Erectile Function endpoints. Intracorporal injections and intraurethral suppositories with
an active ingredient of prostaglandin E1 were
evaluated against the International Index of Erectile Function and logs of patient
and partner satisfaction during three weeks of active treatment. Patients with
erectile dysfunction of all origins were involved in this study, and only those
who had tried either treatment were excluded. The scores at the start of
treatment were 1.7 for Q3, 1.3 for Q4, and 9.2 for the EF domain. Following treatment with
injections, the same measures' scores were increased to 4.4 for Q3, 4.2 for
Q4, and 25.3; the same scores with intraurethral suppositories were 3.0, 2.8 and
17.3. These are all highly significant changes, and were backed up by other
measures including subjective measures of men's and partners' treatment
satisfaction. Summary In summary, the International
Index of Erectile Function has been shown to accurately assess the effects of treatment with a range of
erectile dysfunction therapies. The erectile function domain score is especially sensitive
in measuring changes across a wide range of
treatments. The International Index of Erectile Function as a diagnostic measure The NIH Consensus Panel on Erectile Dysfunction set out several goals for research on
erectile dysfunction. One of them was to create a system for the classification of
erectile dysfunction. This would ensure comparability between studies and
consistency of reporting between cases. The erectile function domain of the IIEF was considered for such a purpose,
since it shows a
high degree of reliability, sensitivity and specificity to treatments. As a
result, a study was conducted to test whether or not the IIEF could distinguish between men with and without
erectile dysfunction, and whether it could classify the severity of a man's
erectile dysfunction. Data from four Viagra trials
on 1035 men were pooled and compared to data from 116 controls. The erectile
function domain proved to be an excellent diagnostic tool which showed high sensitivity and specificity
in classifying and diagnosing men with ED. The optimal cut-off score for the
erectile function domain was established as 25, with men who scored 25 or less
being classified as suffering from erectile dysfunction; further work showed
that men in relationships who were engaging in sexual activity and attempting intercourse,
fell into the following groups: no erectile dysfunction = 26 - 30; mild erectile
dysfunction = 22 - 25; mild to moderate
erectile dysfunction = 17 - 21; moderate erectile
dysfunction = 11 - 16; and severe erectile
dysfunction = 6 - 10. When an
independent study compared a man's erectile function domain score with his own assessment of
the severity of his erectile dysfunction before and after treatment, it was
found that the EF domain score showed a good degree of correlation with
the man's self-assessment of the severity of his erectile dysfunction before,
during and after treatment. In this study, an erection problem was defined as 'not being able to get and/or keep an erection
hard enough for satisfactory sexual intercourse/activity.' There is an abridged 5-item version of the IIEF, which is
called the Sexual Health Inventory
for Men. It has been widely used because of its ease and simplicity in clinical settings in the USA, and,
like the IIEF it has been adopted as a standard diagnostic tool for erectile
dysfunction. The SHIM includes five items from the IIEF which have been shown to
be the best way of separating men
with and without erectile dysfunction. Like the EF domain score of the
International Index Of Erectile Dysfunction, the SHIM has demonstrated a moderate-to-high degree of correlation with
a man's own assessment of the degree of his erectile dysfunction....and, based on this
research, the SHIM seems to provide
a quick and convenient method which can quickly identify men at high risk of erectile
dysfunction who may need clinical assessment. Although the
IIEF has found widespread usage, there are some limitations associated with it. Some of
these are because it focuses on how a man is doing sexually right now in his
life, and it only looks at the question of erectile capacity, while ignoring the
relationship between the man and his partner. Neither does it assess any aspect
of sexual desire or orgasmic capacity. Although it was originally to cover many
aspects of sexual performance, it really only focuses on erectile function, and
studies on erectile dysfunction are where it finds its main use. Another
significant drawback is that it does not work very well for men whose primary
focus of sexual activity is homosexual, since it measures heterosexual activity
and the standard of performance is successful vaginal intercourse. The IIEF is able to offer accurate information about the
severity of a man's erectile dysfunction, but there is little or no no
information in this about the etiology - the origin - of the disorder. Indeed, from a clinical perspective, the IIEF
offers limited information about male sexual
functioning and it cannot serve as a substitute for a detailed medical history and examination.
It has also been suggested that the IIEF is too complicated, since when men are
asked to assess their own erectile dysfunction on a one point scale, the responses
matched
the EF domain scores rather well, and more men completed the question than the
IIEF. There is also some controversy about the accuracy and validity of the SHIM
for diagnostic classification of erectile problems. Even so, the SHIM is in
widespread use and is widely used in clinical settings as a brief tool for
identifying
Conclusion: implications for future research Self-report measures are now the most common way of identifying erectile dysfunction. The IIEF also gives a quantitative index of erectile dysfunction severity for diagnostic and classification purposes. The brief form of the tool, the SHIM, also has found use as a diagnostic aid. Specific areas for more research include addressing incomplete or missing items, additional studies on what men's answers actually mean in relationship and sexual terms, and the effects of particular clinical interventions or causative factors. It may well also be helpful to have more information about demographic and health characteristics, as well as some review of gay men and how they are impacted by this condition. Cure your erectile dysfunction with treatments for erectile dysfunction that actually work.
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