Vardenafil Improves Sexual Function and Treatment Satisfaction in Couples Affected by Erectile Dysfunction (ED): A Randomized, Double-Blind, Placebo-Controlled Trial in PDE5 Inhibitor-Naïve Men with ED and Their Partners

Abstract

Introduction Erectile dysfunction (ED) is a common condition with diverse sequelae affecting men and their women partners. Aim The FINDER study aimed to evaluate the efficacy and tolerability of the phosphodiesterase type-5 (PDE5) inhibitor, vardenafil, in a broad population of PDE5-naïve men with ED of different etiologies and severity and included their partners’ assessments of treatment with vardenafil. Methods Men with ED (N = 260) were randomized to receive either vardenafil or placebo in a multicenter, flexible-dose study. Main Outcome Measures Primary efficacy variables were patients’ responses to the Global Assessment Question (GAQ), and Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3). Results Compared with placebo, vardenafil significantly improved rates of successful “Yes” responses to SEP3 (“Did your erection last long enough for you to have successful intercourse?”) (49% placebo vs. 78% vardenafil at last period carried forward [LPCF]; P < 0.0001), SEP2 (“Were you able to insert your penis into your partner’s vagina?”) (65% placebo vs. 85% vardenafil at LPCF; P < 0.0001), and GAQ (36% placebo vs. 83% vardenafil at last observation carried forward; P < 0.0001). In addition, patients’ and their partners’ Treatment Satisfaction Scale (TSS) scores were statistically significantly improved across each of the TSS domains (satisfaction with orgasm, ease with erection, confidence, pleasure, erectile function satisfaction, and satisfaction with medication) in the vardenafil group compared with the placebo group. Conclusions Vardenafil improved sexual function to the extent that both patients and their partners expressed a considerable and agreed level of satisfaction with treatment.

A typology of men's sexual attitudes, erectile dysfunction treatment expectations and barriers

“…Successful treatment of ED with the PDE-5 inhibitors has been shown to improve the partners' quality of sexual life and the quality of partnership. [27][28][29][30][31] Following the typology, a satisfying sex life was a significantly more important constituent of a partnership for sensation seekers and sensuous than for the other types in our sample.…”

Correlations With Satisfaction Measures in Men Treated With Phosphodiesterase Inhibitors for Erectile Dysfunction

“…The mSLQQ Sexual QoL domain was used in three trials of vardenafil (Fisher, Rosen, Eardley, Sand, & Goldstein, 2005;Goldstein et al, 2005;Rosen, Goldstein, Huang, Bangerter, & Taylor, 2007), one of which sought correlations with the EQS Table 7). The TSS Pleasure domain and Satisfaction With Orgasm domain were used in three trials of vardenafil (Edwards, Hackett, Collins, & Curram, 2006;Rosen, Goldstein, et al, 2007;Rubio-Aurioles, Porst, Eardley, & Goldstein, 2006), one of which sought correlations with the IIEF Erectile Function domain (Rosen, Goldstein, et al, 2007; Table 5). …”

“…The QEQ was used in four trials of sildenafil (Buvat et al, 2008;Jones et al, 2008;Kadioglu et al, 2008;Loran et al, 2009), one of which sought correlations with the IIEF Erectile Function domain and the EHS (Loran et al, 2009), and one of which sought correlations with the EHS (Kadioglu et al, 2008; Tables 5 and 6). The TSS Satisfaction With Erection domain was used in three trials of vardenafil (Edwards et al, 2006;Rosen, Goldstein, et al, 2007;Rubio-Aurioles, Porst, Eardley, & Goldstein, 2006), one of which sought correlations with the IIEF Erectile Function domain (Rosen, Goldstein, et al, 2007;Table 5). …”

Effect of erectile dysfunction medications on coexisting sexual dysfunctions in couples: Partners' Preference Study

“…Numerous studies of the use of oral phosphodiesterase type 5 inhibitors (PDE5i) for the treatment of ED have demonstrated their efficacy with respect to erectile function (Brock et al, 2002;Goldstein et al, 1998), improvement in the quality of life of the men concerned (Dean et al, 2006;Sanchez-Cruz et al, 2003;Shabsigh & Stone, 2006), their self-esteem (Althof, O'Leary et al, 2006) and their satisfaction with treatment (Matic & McCabe, 2007;Porst, Behre, Jungwirth, & Burkart, 2007;Tomlinson & Wright, 2004). However, the treatment of the man's sexual problem has not always resulted in his partner expressing the same satisfaction with the continued use of the medication (Althof, 2002;Chevret, Jaudinot, Sullivan, Marrel, & Solesse de Gendre, 2004;Colson, 2005;Edwards, Hackett, Collins, & Curram, 2006;Fisher, Rosen, Eardley, Sand, & Goldstein, 2005;Goldstein et al, 2005;McCabe, 2008). This disparity in partner satisfaction with treatment has been variously attributed to: (1) required adjustment from the relative lack of intimacy experienced by the couple during the time the man's ED had been present (Althof, 2002;Kingsberg, 2002), (2) sexual difficulties not necessarily being singularities in the age-group of couples typically experiencing ED, (Fugl-Meyer & Fugl-Meyer, 2002) and (3) women maybe being less than enthusiastic about their partners renewed sexual capability because it highlighted their own sexual problems (Cayan, Bozlu, Murat, Canpolat, & Akbay, 2004).…”