ORIGINAL RESEARCH—ED PHARMACOTHERAPY: The South Australian Couples Sildenafil Study: Double-Blind, Parallel-Group Randomized Controlled Study to Examine the Psychological and Relationship Consequences of Sildenafil Use in Couples

ABSTRACT Introduction The South Australian Couples Sildenafil (SACS) study sought to look more closely at the role of sexual functioning in couples by exploring the impact of treatment for erectile dysfunction (ED) with sildenafil. Aim The SACS study investigated the individual and dyadic impact of the drug sildenafil (Viagra) on couples over a 6-month period. Main Outcome Measures A range of outcome measures were utilized including the Dyadic Adjustment Scale (DAS), the International Index of Erectile Function (IIEF), and the Erectile Dysfunction Inventory of Treatment Satisfaction. Methods Couples were recruited through the use of local media and general practitioners. Couples were randomly allocated to placebo or active drug with the option of using up to one study tablet per day for 6 months. Couples were reviewed at 2 weeks, 4 weeks, 8 weeks, 3 months, and 6 months. Results There were 108 couples who were eligible for the study with the eventual analysis including 49 couples in the active treatment group and 47 in the placebo group with similar demographic and background profiles found in both groups. A large number of psychosocial, quality-of-life, and sexual measures were recorded at the end of the trial for both male subjects and their female partners. Predictably, the erectile response in the active treatment group showed a significant improvement as measured by the IIEF although no change was found between the active and placebo groups in relationship functioning as measured by the DAS scores. Conclusions The SACS study found no difference between treatment arms with regard to relationship functioning after the use of sildenafil for ED. Potential contributing factors to a “no change” result are discussed. The SACS study adds to the available literature on psychological and interpersonal factors in the treatment of ED which have not been sufficiently investigated until recently. Hundertmark J, Esterman A, Ben-Tovim D, Austin M-A, and Dougherty M. The South Australian Couples Sildenafil Study: Double-blind, parallel-group randomized controlled study to examine the psychological and relationship consequences of sildenafil use in couples.