Th. Klotz, M.J. Mathers, R. Klotz, F. Sommer

Journal of Sexual Medicine 2007;4:162-165

Phosphodiesterase 5-inhibitors are an efficacious therapy in men with erectile dysfunction. There are only few studies which also focus on the participating couples during PDE5-inhibitor therapy.

Patients responding to Phosphodiesterase type 5-inhibitor therapy - what do their sexual partners know?

Introduction: Phosphodiesterase 5-inhibitors are an efficacious therapy in men with erectile dysfunction. There are only few studies which also focus on the participating couples during PDE5-inhibitor therapy.

Aim: Determination to which extent patients personally informed their sexual partners about their ongoing PDE5-inhibitor therapy.
Main outcome measures: Likelihood of informing the female partner by the patient himself about the use of PDE5 inhibitors.

Methods: 216 men (mean age 62.3 years) with ED were successfully treated with PDE5-inhibitors in 3 independent centres. After an interval of at least 3 months of successful ED therapy, all patients were asked by a questionnaire if their sexual partners were informed of their PDE5-inhibitor therapy.

Results: 82% of the patients were exclusively involved in one stable sexual relationship, 9.7% of the men admitted to having changing sexual partners and 6% did not give any information at all about their sexual partners. 20% of the men had an a severe ED (IIEF-5 <11). 49% showed a moderate ED (IIEF-5 11-16) and 31% suffered a mild ED (IIEF-5 >16). PDE5-inhibitor medication was used 1.2 /month by men with a severe ED, 2.1/month by patients with a moderate ED and 2.9/month by men with a mild ED. 41 (93%) of the 44 patients with a severe ED informed their sexual partners that they were taking PDE5-inhibitors. In the patient group with moderate ED 49 (47%) of 105 patients and only 14 (21%) of 67 of the patients with mild ED shared this information with their partners.

Conclusion: Less than 40% of the patients suffering a moderate or mild ED using PDE5-inhibitors shared this information with their partners. It seems that patients find ED so disturbing that many patients do not inform their partners of PDE5-inhibitor use.

Key words: Erectile dysfunction; PDE5-Inhibitors; Sexual partner; Male attitudes



Patients Receiving Phosphodiesterase 5-inhibitor therapy - what do their sexual partners know?

Introduction
Erectile dysfunction (ED) is defined as the inability to attain and /or maintain penile erection sufficient for satisfactory sexual performance.
Phosphodiesterase 5-inhibitors such as sildenafil, vardenafil and tadalafil have been shown to be an efficacious therapy in approximately 60-80% of patients with erectile dysfunction (ED), depending on the aetiology. It has been estimated that in 1995 over 152 million men worldwide were affected by ED and that in 2025 its prevalence worldwide will be approximately 322 million men [1]. Due to the nature of the disease one can assume that almost the same number of sexual partners are indirectly affected by treatment. The portion of men requiring such treatment for ED is highest in the age group of 60-69 years of age [2]. While numerous studies have reported on the prevalence and incidence of erectile dysfunction (ED), most have not analysed the experience and characteristics of the treated men and their sexual partners. A previous study determined the rate of abandonment of an effective therapy, where the majority of patients reported that they had no opportunity or desire for sexual intercourse or that their partners had shown no sexual interest [3]. It is well known that sexual dysfunction has a negative impact on quality of life. The resulting psychological consequences of ED frequently include depression, performance anxiety and relational distress [4]. One can imagine that men would like to prevent such tension in their partnerships and perhaps not mention their PDE5-inhibitor therapy to their partners even though it is generally acknowledged that the sexual partners should be informed and involved in ED therapy. One can imagine that an open discussion of impotence during therapy is important for a satisfying sexual experience for both partners. Recent studies have shown, that the proportion of women who experience a satisfying sexual experience was significantly higher in the group whose partners were currently using a PDE5-inhibitors [5,6].
Up to now there are only few studies which focus on the couple during PDE5-inhibitors therapy. The rationale of this study was to determine to which extent patients personally informed their sexual partners about their ongoing PDE5-inhibitor therapy.

Patients and Methods
This study included patients from 3 independent centres (private urologist’s office, general practitioner’s office and an outpatient clinic of a urological department) in 3 different regions in Germany. Within a time period of 20 months (6/2003 - 1/2005) a cohort of 235 patients, who responded to PDE5-inhibitors were successfully treated for ED either with 50-100 mg sildenafil, 10-20 mg vardenafil or 10-20 mg tadalafil. Patients who did not respond to PDE5-inhibitors were not subjects of the study. The mean age of responders was 62.3 years. A routine diagnostic workup was performed on all patients and each patient was classified according to the International Index of Erectile Function (IIEF-5). According to recently published papers patients with a score of less than 11 were estimated to suffer a severe ED, a score between 11 and 16 suggested a moderate ED and a mild ED was assumed when the IIEF-5 score was higher than 16 [4,7,8]. When initially visiting the office and assuring confidentiality, a questionnaire was used to ask patients of their sexual orientation and the stability of their relationship. After three months of successful ED therapy all patients filled out a second questionnaire. Here our main interest was how often they took PDE5-inhibitors and if their sexual partners were informed. The study was planned as a descriptive pilot study of a consecutive cohort of PDE5-responders. Thus it does not seem to be useful to perform a statistical treatment of the findings or multivariate logistic regression analysis.


Results
All consecutive ED patients, who responded to PDE5-inhibitors participated in the study. One patient dropped out because he could not be successfully treated with either of the PDE5-inhibitors, 10 patients discontinued the study because of lack of sexual opportunity and 7 patients were lost to follow-up. One patient discontinued therapy because of side effects. Complete information was obtained on 216 men, who were PDE5i-responders and which all answered to be heterosexual. Information pertaining to marriage was not obtained. We have to stress a potential selection bias, because of the sample cohort constituted exclusively by responders to PDE5-inhibitors. We did not take into account the data of PDE5i-non responders.
According to the questionnaire at the time of treatment 182 of 216 patients (84%) were solely involved in one stable sexual relationship. 21 (9.7%) men admitted to having changing sexual partners and 6% (13/216) didn’t give any information at all about their sexual partnerships. 177 men (82%) were found to have an ED of organic nature. There were the typical comorbidities as hypertension, diabetes mellitus etc.
Through the routine diagnostic workup patients were classified in three groups according to the "International Index of Erectile Function” (IIEF-5). 44 of 216 men (20%) had an IIEF-5 < 11 which corresponds to a severe ED. 105 (49%) patients showed a moderate ED with a IIEF-5 between 11 and 16. A mild ED (IIEF-5 >16) was present in 67 (31 %) men.
The mean age was 62.3 years. When stratified by IIEF-5 the average age with an IIEF-5 < 11 was 66.4 years, an IIEF-5 between 11-16 was 63.1 years and a IIEF-5 > 16 was 58.2 years of age.
Using the second questionnaire after 3 months of successful treatment, patients in the IIEF-5 < 11 group answered they on average took the on-demand pill 1.2 times/month. Patients in the IIEF-5 group of 11-16 said they made use of the PDE5-inhibitor 2.1 times/month and the men with mild ED according to the IIEF-5 with a score more than 16 the frequency of PDE5-inhibitor was 2.9 times/month. According to the same questionnaire 41 (93%) of the 44 patients with a severe ED (IIEF-5 < 11) informed their sexual partners that they were taking PDE5-inhibitors. In the patient group with moderate ED (IIEF-5 11-16) 49 (47%) of 105 patients and only 14 (21%) of 67 of the patients with mild ED (IIEF-5 > 16) shared the information that they were using PDE5-inhibitors (figure 1).

Discussion
Epidemiological studies have shown that there is an age dependent increase in ED. Whereas only approximately 2% of he 30 year-olds are affected, this rate increases to 53% in patients 70 years and older [2]. At the same time the severity of ED also increases with age. The results of our study confirm this situation. Whereas patients with an IIEF-5 of >16 (mild ED) were on average 58.2 years old, patients with a severe ED (IIEF-5 <11) were 66.4 years of age.
In the past it was assumed that psychological factors were the cause in about 80% of the ED cases. In the meantime it is widely accepted that approximately 60-70% of ED are of organic origin, which can easily to be accounted for by general symptoms of aging.
Our results also confirm the known fact that with the severity-increase of ED the frequency of PDE5-inhibitor intake decreases. We could show that with an increase in age of the patient and the lower the IIEF score was, the less the patient was willing to treat his ED with a on-demand PDE5-inhibitor.
In recent years and especially after the "Viagra® -Effect” which had a pronounced influence on patient behaviour by the mass media [7], more studies are gradually taking an interest in the sexual partners of men being treated with PDE5-inhibitors. Sexual partners of impotent men suffer under this condition [9]. It has been shown that about 85% of the sexual partners are satisfied with their sexual relationship before ED begins, after the occurrence of impotence only 39% are satisfied with the situation. Many studies indicated that the quality of partnership is significantly better in appropriately treated ED patients than in untreated controls [5,6,].
We found out that informing the sexual partner of ED therapy is dependent on the the severity of the disease. According to our results, patients with a severe ED tend to inform their sexual partners more frequently about their ED therapy than men with a moderate or mild ED. 93% of the men with a severe ED (IIEF-5 <11), which on average were older (mean age 66.4 years) than the men with an IIEF-5 >11, involved their sexual partners in their therapy. On the other hand less than 40% of the patients with moderate to mild ED (IIEF-5 >11) informed the sexual partners that they were taking PDE5-inhibitors for ED. Taking into consideration that all patients visited the physicians office because of ED, one can assume that these men experienced their sexual dysfunction as a distress and unhappiness leading to the need for therapy. This is noteworthy since we know that not all patients suffering from ED have a desire for treatment [2]. It could be suggested that especially younger men with ED have a problem admitting their ED to their sexual partners. It could very well be that men experiencing ED are ashamed to admit their disease to their partners especially since this could even further increase their performance anxiety and relational distress which is often associated with ED [9,10,11]. Our study has some limitations. We have to stress a potential selection bias, because of the sample cohort constituted exclusively by responders to PDE5-inhibitors. We did not take into account the data of PDE5-non responders. Furthermore we did not perform multivariate logistic regression analysis because the study was planned as a simple descriptive study. That is why we cannot determine exactly which factors predict the partners knowledge of PDE5-inhibitor use. Therefore there is a strong need of further studies, which corroborate and elucidate our findings.
Nevertheless ED treatment should be openly discussed in the partnership . This could assist in relieving pressure from the patient and the couple in general. This seems reasonable because the majority of patients live in a stable relationship.

Conclusion
Less than 40% of the patients suffering a moderate or mild ED informed their partners about the use of PDE5-inhibitors. It seems that patients find ED so disturbing that many patients do not inform their partners of PDE5-inhibitor use. Furthermore the absence of partner information in men with ED using PDE5-inhibitors may be a potential risk because of specific side effects of medication and comorbdities of ED. ED treatment should be openly discussed in the partnership in order to relieve pressure from the patient and the couple.



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