Elsevier

The Journal of Sexual Medicine

Volume 7, Issue 9, September 2010, Pages 3170-3178
The Journal of Sexual Medicine

ORIGINAL RESEARCH
Interrelationship of Sildenafil Treatment Effects on the Physiological and Psychosocial Aspects of Erectile Dysfunction of Mixed or Organic Etiology

https://doi.org/10.1111/j.1743-6109.2010.01882.xGet rights and content

ABSTRACT

Introduction

In a previous paper using mediation modeling, the direct and indirect effects of sildenafil on erection maintenance were demonstrated.

Objective

In an extension of this previous work, the historical psychosocial paradigm of ED, which focuses on performance anxiety, is tested by using mediation modeling to define the relationship of the physiological aspects (hardness and maintenance) and the associated psychosocial aspects (confidence, sexual relationship satisfaction, and performance anxiety) of ED.

Methods

Statistical mediation analysis using the following outcomes from a double-blind placebo-controlled trial of fixed-dose sildenafil 100 mg or 50 mg: Erection Hardness Score; the 15-item International Index of Erectile Function (IIEF), including item 4 (frequency of erection maintenance after penetration) and item 5 (difficulty of erection maintenance to intercourse completion); the Self-Esteem And Relationship questionnaire; and the question, “Do you feel anxious about your next attempt at sexual intercourse?”

Main Outcome Measures

Estimated percentages of direct and indirect effects of sildenafil on psychosocial aspects of ED (95% confidence intervals).

Results

The model estimated that erection hardness mediated 43.7% (29.3%, 62.4%) of the effect of treatment onto confidence and 45.9% (32.2%, 61.8%) of the effect of treatment onto sexual relationship satisfaction, and that erection maintenance (using IIEF item 4 as a proxy) mediated 23.0% (10.1%, 39.1%) and 22.4% (10.1%, 36.5%), respectively. Similar results were obtained when IIEF item 5 was used as the proxy for measurement of maintenance. Of all possible paths to performance anxiety, only that from treatment via confidence was statistically significant, mediating an estimated 88.6% (55.5%, 146.2%; item 4 model) or 74.9% (47.0%, 121.0%; item 5 model) of the effect of treatment onto anxiety. The direct path to anxiety from treatment was not statistically significant.

Conclusions

In men treated with sildenafil for ED, performance anxiety might be ameliorated by improved confidence. Improved confidence might be mainly mediated via increased erection hardness. Althof SE, Berner MM, Goldstein I, Claes HIM, Cappelleri JC, Bushmakin AG, Symonds T, and Schnetzler G. Interrelationship of sildenafil treatment effects on the physiological and psychosocial aspects of erectile dysfunction of mixed or organic etiology.

Introduction

The inability to have or successfully complete intercourse can affect a man's quality of life and is associated with anxiety and loss of self-esteem [1]. Performance anxiety (anxiety about the ability to respond sexually) may always be present at some level in men with erectile dysfunction (ED). With each successive sexual failure, performance anxiety may escalate, further worsening sexual responsiveness and leading men to avoid future sexual interactions 1, 2.

Treating the functional (physiological) aspects of ED (erection hardness and erection maintenance) is one of the key steps in overcoming performance anxiety. The phosphodiesterase type 5 inhibitor (PDE5) sildenafil citrate (VIAGRA®, Pfizer Inc, New York, NY, USA) is a proven treatment for ED [3]. The impact of sildenafil on erectile function and erection hardness, and the resulting improvement in confidence, sexual relationship satisfaction, and the level of anxiety about the next intercourse attempt, were assessed in men with ED in a double-blind placebo-controlled (DBPC) trial of sildenafil at a fixed dose of 50 mg or 100 mg [4]. The effect of sildenafil on erection maintenance, indirectly (mediated through erection hardness) and directly, was previously estimated [5].

In follow up to the previous modeling of the relationships between the physiological aspects of the treatment of ED (i.e., hardness and maintenance), the main objective of the current report is to test the historical psychosocial paradigm of ED, which focuses on performance anxiety, by using mediation modeling to define the relationship of the physiological aspects (hardness and maintenance) and the associated psychosocial aspects (confidence, sexual relationship satisfaction, and performance anxiety) of ED.

Section snippets

Data Set

The data set, which was described previously [4], was derived from a multinational (Republic of Korea, Russian Federation, Spain, and Sweden), parallel-group, randomized (1:1:1), DBPC trial of fixed-dose sildenafil (100 or 50 mg, 8 weeks) with open-label (OL) extension of flexible-dose sildenafil (50 and 100 mg, 4 weeks). Medication was taken as needed for sexual activity but not more than once daily. Inclusion criteria were age ≥18 years; a clinical diagnosis of ED confirmed by a score ≤25 out

Results

The 288 men randomized to sildenafil 50 mg (N = 94), sildenafil 100 mg (N = 99), or placebo (N = 95) were similar in age (mean, 51 years; range, 20–65 years) and ethnicity (approximately two thirds white and one third Asian). Most had ED of organic or mixed etiology.

Discussion

There are many published reports of the effect of ED treatment on erection hardness, erection maintenance, and erectile function. It has also been demonstrated that psychosocial outcomes, including sexual confidence, can be improved by sildenafil or by other PDE5s 3, 17, 18, 19, 20, 21, 22, 23, 24. Furthermore, correspondence between scores on the EHS and scores on other ED-specific patient-reported outcomes (i.e., the IIEF, the Quality of Erection Questionnaire, the Sexual Experience

Potential conflicts of Interest

Dr Althof receives research support from Boehringer Ingelheim Corporation and Plethora, and is a consultant to Eli Lilly and Company, Boehringer Ingelheim Corporation, GlaxoSmithKline, Johnson & Johnson, Palatin Technologies, Pfizer Inc, and Plethora. Dr Althof is also a speaker for Eli Lilly and Company and Boehringer-Ingelheim.

Dr Berner is a consultant to Boehringer Ingelheim and Pfizer Inc. He received research grants or tuition fees from the Federal Ministry for Education and Research of

Category 1

  • (a)

    Conception and Design

    Joseph C. Cappelleri; Andrew G. Bushmakin; Tara Symonds; Gabriel Schnetzler

  • (b)

    Acquisition of Data

    Stanley E. Althof; Michael M. Berner; Irwin Goldstein; Hubert I.M. Claes; Joseph C. Cappelleri; Andrew G. Bushmakin; Tara Symonds; Gabriel Schnetzler

  • (c)

    Analysis and Interpretation of Data

    Stanley E. Althof; Michael M. Berner; Irwin Goldstein; Hubert I.M. Claes; Joseph C. Cappelleri; Andrew G. Bushmakin; Tara Symonds; Gabriel Schnetzler

Category 2

  • (a)

    Drafting the Article

    Stanley E. Althof; Michael M.

Acknowledgements

This study was sponsored by Pfizer Inc. Editorial support was provided by Deborah M. Campoli-Richards, BSPHA, RPh, of Complete Healthcare Communications, Inc., and was funded by Pfizer Inc.

References (29)

Cited by (28)

  • Digital Real-world Data Suggest Patient Preference for Tadalafil over Sildenafil in Patients with Erectile Dysfunction

    2022, European Urology Focus
    Citation Excerpt :

    One probable reason for this preference is the higher flexibility gained by the significantly longer half-life compared with that of sildenafil [6,7]. This is supported by the studies of Rubio-Aurioles et al [13], Althof et al [23], and Tsujimura et al [24], which showed that routine and PRN tadalafil demonstrated great improvements in sexual self-confidence, time concerns, and spontaneity when compared with PRN sildenafil. We must acknowledge the limitations of this retrospective cross-sectional study without randomization.

  • Erectile dysfunction and adherence to antihypertensive therapy: Focus on β-blockers

    2020, European Journal of Internal Medicine
    Citation Excerpt :

    On the other hand, improvements in erectile function were related with benefits in self-esteem and mood in men with ED. Importantly, use of PDE-5 inhibitors was associated with amelioration of self-confidence and esteem, sexual satisfaction, relationship status, psychological status, vitality, general health and depressive symptoms [54,55]. Of importance, ED not only affects the quality of life of the affected individual, but may also result in sexual and emotional impairment of the sexual partners [56].

  • Combination of psychological intervention and phosphodiesterase-5 inhibitors for erectile dysfunction: A narrative review and meta-analysis

    2014, Journal of Sexual Medicine
    Citation Excerpt :

    As combined treatment seems a more promising treatment option than single treatment, such trials should be prioritized in order to come to stronger conclusions about the importance of such combinations. So far the working mechanism of the add‐on effect of PI is unclear, and various possible explanations should be tested [56,57]. The better outcome of the combined treatment compared with PDE‐5I use alone could be due to (i) better compliance with PDE5‐I regimen (medical explanation); (ii) a decrease in performance anxiety (psychological explanation [58]); or (iii) nonspecific elements of the PI.

View all citing articles on Scopus
View full text