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Evaluation of the effectiveness of sildenafil using questionnaire methods versus audio-visual sexual stimulation

Blackwell Science, LtdOxford, UKIJUInternational Journal of Urology0919-81722005 Blackwell Publishing Asia Pty LtdMarch 2005123369373Original ArticleEvaluation of sildenafil using audio-visual sexual stimulationT Suetomi International Journal of Urology (2005) 12, 369–373
Evaluation of the effectiveness of sildenafil using
questionnaire methods versus audio-visual
sexual stimulation
TAKAHIRO SUETOMI, FUMIYASU ENDO, HITOSHI TAKESHIMA ANDHIDEYUKI AKAZA Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba, Japan Abstract
Aim: In the present study, an audio-visual sexual stimulation (AVSS) test was used to evaluate the
effectiveness of sildenafil, and the AVSS test was coevaluated with the international index of erectile
function (IIEF) questionnaire.
Methods
: Forty-two patients with erectile dysfunction (ED) were examined (age range, 28–73 years;
mean, 51.9 ± 11.4 years). Each patient answered the IIEF questionnaire and underwent laboratory
tests and the AVSS test before administration of sildenafil. The IIEF questionnaire and AVSS test
(1 h after administration of 25 mg or 50 mg sildenafil) were re-evaluated in the outpatient clinic
4 weeks later. Questions 3 and 4 of the IIEF test were used to evaluate the effectiveness of sildenafil.
Sildenafil was determined to be effective if each score totalled four or five after administration.
Results
: The rate of effectiveness of sildenafil was 52.4%, and the mean score of the IIEF 5 improved
from 7.2 to 15.4 following treatment with sildenafil. The maximum and mean rigidity of the penile
tip improved after the sildenafil treatment (36.1% vs 57.7% and 14.2% vs 35.8%, respectively). The
maximum and mean rigidity of the penile base rose (42.4% vs 57.7% and 17.9% vs 36.8, respec-
tively). Similarly, following treatment with sildenafil, the penile tumescence increased from 6.6 cm
to 7.6 cm at the penile tip and from 7.5 cm to 8.5 cm at the penile base.
Conclusions
: In some ED patients the results of the IIEF questionnaire are not always consistent
with those of objective evaluation, including AVSS. In these patients, combined assessment using
the IIEF and AVSS might be more useful to evaluate the precise effectiveness of sildenafil, rather
than relying on the IIEF results alone.
Key words
audio-visual sexual stimulation, erectile dysfunction, sildenafil.
Introduction
questionnaires are widely used as tools to evaluate theeffectiveness of sildenafil.1 However, questionnaire tests Since March 1999, sildenafil citrate (Viagra) has been available in Japan and it has become the first choice for At the Department of Urology, University of treatment of erectile dysfunction in many cases. The Tsukuba, Tsukuba, Japan, sildenafil has been prescribed international index of erectile function (IIEF) and other to patients with erectile dysfunction since 1999, in addi-tion to conventional treatment measures.
To evaluate the effectiveness of sildenafil, the audio-visual sexual stimulation (AVSS) test is given to Correspondence: Takahiro Suetomi MD, Department of patients with informed consent, in addition to the IIEF Urology, Institute of Clinical Medicine, University ofTsukuba, 1-1-1 Tennodai, Tsukuba-city, Ibaraki 3058575, We report here the usefulness of the AVSS test in Received 23 January 2004; accepted 24 August 2004.
evaluating the effectiveness of sildenafil.

AVSS test
Patients
A commercially available virtual glasses set, EyeTREK(FMD-011F, Olympus Optical, Tokyo, Japan) was used A total of 42 men with erectile dysfunction (ED) who to stimulate the patients visually for the AVSS test.
visited our clinic between May 1999 and May 2003 were These glasses have tri-dimensional viewing capability, are equipped with stereophonic headphones and can The mean age of the patients was 51.9 ± 11.4 years keep the patient’s feelings away from the surrounding (range, 28–73 years), and the mean duration of erec- environment. The 30-min erotic video was shown indi- tile dysfunction was 13.9 ± 11.7 months (range, 1– vidually to each patient in a dark and silent room. A 48 months). All patients had a sexual partner and different movie was used for each AVSS test. The penis had not received any previous treatment for erectile of the patient was connected to the RigiScan-Plus device according to the instruction manual, and the device The etiology of ED was determined by anamnestic automatically determined the baseline penile rigidity documentation, medical history, and a nocturnal penile and tumescence for the first 15 min, and then stimulated tumescence (NPT) test using a snap-gauge (Timm Med- rigidity and tumescence for the next 30 min. In this ical Technologies, Eden Prairie, MN) at home (Table 1).
study, manual stimulation of the penis was prohibitedduring the session.
Baseline evaluation
Statistical analysis
All patients underwent baseline evaluation, includingvital signs, the IIEF questionnaire, serum concentrations Data analysis was performed with the Wilcoxon signed- of hormones (testosterone, luteinizing hormone [LH], rank test. Results were considered statistically signifi- follicle stimulating hormone [FSH], prolactin, and estra- diol) and the AVSS test with a RigiScan-Plus. Twenty-five milligrams of sildenafil was administrated to allpatients without contraindication for the first treatment.
If the ED was not sufficiently improved with 25 mg ofsildenafil, then 50 mg of sildenafil was prescribed.
Results of questionnaire
Efficacy assessments
Of the 42 patients, 22 (52.4%) reported effective resultsin assessment with the IIEF. There was no significant Patients revisited our clinic 4 weeks after the sildenafil difference in age between the effective group and the administration and answered the IIEF questionnaire and ineffective group (53.6 vs 51.0 years old). Ten (55.6%) took the AVSS test (1 h after administration of 25 mg of 18 patients with organic erectile dysfunction reported or 50 mg of sildenafil). Questions 3 (Q3, ability to that sildenafil was effective. Fifty percent of those (seven achieve an erection) and 4 (Q4, ability to maintain an of 14) with functional erectile dysfunction and 50% erection) of IIEF were used to evaluate the effectiveness (five of 10) with mixed etiological erectile dysfunction of sildenafil according to the definition of the National reported that it was effective in the IIEF evaluation.
Institute of Health (NIH).2 If each score was four or No significant difference was found among the three higher after administration, sildenafil was determined to groups. For other questions, the average scores were 1.0–2.0 higher than the pretreatment scores. The meanscore of the IIEF-5 for all patients significantly improvedfrom 7.2 ± 4.6 to 15.4 ± 6.6 (Table 2). The mean IIEF- 5 score was elevated from 7.9 ± 4.9 to 19.8 ± 2.8 in theeffective group (22 patients), and from 6.4 ± 4.3 to 10.5 ± 6.0 in the ineffective group (20 patients).
Results of the AVSS test
With AVSS, the maximum rigidity improved from 36.1% to 57.7% at the penile tip and from 42.4% to 57.7% at the penile base for all cases. In the effective Evaluation of sildenafil using audio-visual sexual stimulation Mean of the IIEF-5 score before and after administration of sildenafil Maximum rigidity before and after administration of sildenafil Mean rigidity before and after administration of sildenafil Mean of the tumescence before and after administration of sildenafil group, the maximum rigidity was elevated from 51.5% Penile tumescence increased from 6.6 cm to 7.6 cm to 81.2% at the tip and from 59.3% to 77.2% at the base.
at the penile tip and from 7.5 cm to 8.5 cm at the penile However, lower rates of increase were found for the base, overall. In the effective group, penile tumescence increased from 6.8 cm to 8.4 cm at the tip and from The mean rigidity improved from 14.2% to 35.8% at 7.9 cm to 9.3 cm at the base. In the ineffective group, the penile tip, and from 17.9% to 36.8% at the penile penile tumescence virtually did not respond to the treat- base overall. In the effective group, the mean rigidity improved from 22.7% to 52.5% at the tip and from The AVSS test can also evaluate the rigidity activity 28.4% to 53.7% at the base. The rates of increase for unit (RAU) and tumescence activity unit (TAU), which the effective group were also higher than those of the represent the maintenance of erection. The average RAU for all cases improved from 2.8 to 7.6 at the penile tip and from 3.3 to 7.8 at the penile base. The Adverse reactions were observed in three patients in the average RAU of the effective group was increased 25 mg sildenafil group. Two patients had flushing, and from 4.0 to 10.1 at the tip and from 4.8 to 10.6 at the The average TAU for all cases improved from 1.8 to 5.5 at the penile tip and from 2.4 to 5.7 at the penile Discussion
base. In the effective group, TAU increased from 2.5 to7.8 at the tip and from 3.3 to 7.5 at the base. RAU and Sildenafil citrate, which was approved for the oral treat- TAU responded to sildenafil treatment more highly in ment of erectile dysfunction in Japan in 1999, has had the effective group than in the ineffective group a great influence on the management of erectile dys- function. It has become the first choice for the treatment,based on the ‘goal directed approach’, proposed by Lue Serum hormone levels
Clinicians prescribe sildenafil for almost all patients The mean baseline serum hormone levels (standard val- with erectile dysfunction, after taking a detailed medical ues) are as follows: testosterone 435.7 (250–1100) ng/ history and performing physical examinations and blood tests. The effectiveness of sildenafil is generally 8.2) mIU/mL, prolactin 6.5 (1.5–9.7) ng/mL, and estra- assessed using questionnaire tests including the IIEF-5.4 Because the IIEF is a simple, reliable and inexpensive In two patients, a low serum concentration of total tool for assessment of erectile function, it is widely used testosterone was observed. These two patients consisted for the diagnosis of erectile dysfunction and evaluation of one sildenafil effective and one ineffective case. No of the treatment. However, because it is a self-evaluation statistical correlation between the effective rate and method, it is not always objective. Furthermore, it can- serum hormone levels was found (data not shown).
not differentiate vasculogenic and psychogenic eti-ologies. To assess the effectiveness objectively and Adverse reactions
distinguish between organic and psychogenic erectiledysfunction, it is necessary to perform objective tests In the present study, 10 (23.8%) patients were given (e.g. the AVSS test, color duplex Doppler ultrasonogra- 50 mg of sildenafil, and 32 patients were given 25 mg.
Mean of the rigidity activity unit before and after administration of sildenafil Mean of the tumescence activity unit before and after administration of sildenafil Evaluation of sildenafil using audio-visual sexual stimulation Because the AVSS test can detect an erectile response In contrast, in the latter four patients who were con- better than a vasoactive agent injection test, AVSS is tent with sildenafil, the pretreatment average rigidity thought to be one of the best evaluation methods.5 It has was nearly zero. After treatment, however, the average also been reported that the rigidity measured with the rigidity rose to 40%. These patients may have been RigiScan-Plus is correlated with the intracavernous satisfied with this increase, or alternatively, they might pressure.6 These facts suggest that the AVSS test is use- achieve full erection at home in spite of poor erection ful to determine the vascular cause of erectile dysfunc- tion, which can be treated with sildenafil.
These results suggest that there are some patients However, there are several problems associated with whose results differ between the questionnaire method the AVSS test: (i) If patients are repeatedly exposed to and the more objective evaluation. Therefore, we con- the sexual stimulation, the AVSS test might result in a sider that a combination assessment with the IIEF-5 and false negative response;7 (ii) several factors, such as AVSS is more useful than the questionnaire method exposure to the same erotic video, lack of interest in alone, particularly when correct evaluation of the effec- erotic movies, anxiety associated with their general health, age, unfamiliar surroundings or connection to In conclusion, our small clinical study suggests that the measuring equipment might generate false negative the AVSS test is one of the best available methods for responses; and (iii) although sildenafil might provide the best effect on erections at home, it is not certain whetheran accurate evaluation can we obtained using an in-office test.8 References
Reportedly, the maximum rigidity of the penis is a predictor of the possibility of vaginal penetration, and Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick its positive predictive value is 70% or higher.9 In the J, Mishra A. The international index of erectile function present study, the number of patients whose maximum (IIEF): a multidimensional scale for assessment of erec- penile rigidity was >70% was 22, which accounted for tile dysfunction. Urology 1997; 49: 822–30.
the same proportion as in the questionnaire test. It has National Institute of Health (NIH). Consensus develop-
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than 40%.9 In the present study, there were 21 (50.0%) Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena patients whose average penile rigidity was >40%. These BM. Development and evaluation of an abridged, 5-itemversion of the international index of erectile function results suggest that the AVSS test is as useful as the (IIEF-5) as a diagnostic tool for erectile dysfunction. Int. IIEF-5 in evaluating the effectiveness of sildenafil.
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Kim SC, Bang JH, Hyun JS, Seo KK. Changes in erec- In the former four cases, the pretreatment average tile response to repeated audiovisual sexual stimulation.
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Ranzi A, Artibani W. Audiovisual sexual stimulation by For these patients, the tumescence, RAU and TAU after virtual glasses is effective in including complete cav- treatment exceeded the mean levels. Based on these ernosal smooth muscle relaxation: a pharmacoca- results, therefore, treatment was assessed as effective.
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However, the patients might not have been satisfied with Soh J, Naya Y, Kawauchi A, Fujito A, Fujiwara T, Miki the relatively small increase in rigidity, from 40% to T. [The examination using audio-visual sexual stimula- 70%, which is why the IIEF-5 tests showed ineffective tion (AVSS) test for the effectiveness of sildenafil cit- results of the sildenafil treatment.
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