title: An integrated approach with vardenafil orodispersible tablet and cognitive behavioral sex therapy for treatment of erectile dysfunction: a randomized controlled pilot study.
abstract: Erectile Dysfunction is considered a multifactorial disease, where organic and psychological aspects are often interconnected. In a randomized controlled pilot study, we compared the efficacy of combined vardenafil orodispersible tablet (VARD) and cognitive-behavioral sex therapy (CBST) vs. VARD alone in improving sexual symptoms in both male and female partners. Thirty male patients with erectile dysfunction, and their partners were randomly assigned with a 2 : 1 ratio, to two different arms and treated for 10 weeks with VARD (Group A; n = 19) or VARD+CBST (Group B; n = 11). International Index of Erectile Dysfunction (IIEF-15), Female Sexual Function Index (FSFI) and Index of Sexual Satisfaction (ISS) were, respectively, administered to male, female, and both partners at times (T) 0, 1 (+5 weeks of therapy) and 2 (+10 weeks of therapy). Groups A and B were similar in their sociodemographic and clinical characteristics. Pre-treatment (T0) test scores did not significantly differ among the groups. In both group A and B, the IIEF-Erectile Function domain showed a significant improvement from T0 to T1 (p = 0.005 and p < 0.0001 vs. T0, respectively) and from T0 to T2 only in group B (p = 0.013). In group A, FSFI and both male and female ISS did not show any significant change at T1 and T2 vs. T0. In group B, a significant improvement at final time-point in FSFI and male and female ISS scores was reported (p < 0.05, T2 vs. T0 in all scores). The results of our study suggest that both VARD alone and VARD+CBST improved erectile function, however, only VARD+CBST improved couple sexual satisfaction and female sexual function.
authors: Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
authors: V
authors: V
authors: Boddi
authors: Psychiatry Unit, Department of Neurological and Psychiatric Sciences, University of Florence, Florence, Italy.
authors: G
authors: G
authors: Castellini
authors: Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
authors: H
authors: H
authors: Casale
authors: Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
authors: G
authors: G
authors: Rastrelli
authors: Oncology Department, Careggi Hospital, Florence, Italy.
authors: L
authors: L
authors: Boni
authors: Endocrinology Unit, Maggiore-Bellaria Hospital, Bologna, Italy.
authors: G
authors: G
authors: Corona
authors: Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy.
authors: M
authors: M
authors: Maggi
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003075:Coitus / Q000502:physiology*; D007172:Erectile Dysfunction / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects / Q000523:psychology; D010865:Pilot Projects; D057566:Self Report; D012725:Sexual Behavior / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000069058:Vardenafil Dihydrochloride / Q000627:therapeutic use*
chemical_list: D000069058:Vardenafil Dihydrochloride
keywords: erectile dysfunction; sex therapy; treatment