The South Australian Couples Sildenafil Study:Double - Blind, Parallel - Group Randomised Controlled Study To Examine The Psychological And Relationship Consequences Of Sildenafil Use In Couples

Aims and introduction: The South Australian Couples Sildenafil (SACS) study investigated the individual and dyadic impact of the drug Sildenafil (Viagra trademark) on couples over a six month period.  Methods and materials: 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 six months. Couples were reviewed at two weeks, four weeks, eight weeks, three months and six months.  A range of outcome measures were utilised including the Dyadic Adjustment Scale, the International Index of Erectile Function, the Erectile Dysfunction Inventory of Treatment Satisfaction, The World Health Organisation Quality of Life Scale and The Centre for Marital Health Sexual Functioning Questionnaire.  Results: Of the 108 couples eligible for the study, 98 were randomised to Placebo or Active drug.  The eventual analysis included 49 couples in the Active treatment group and 47 in the Placebo group with similar demographic and background profiles found in the two 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. Discussion and Conclusions: The SACS study found no difference between treatment arms with regard to relationship functioning after the use of sildenafil for erectile dysfunction. 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 erectile dysfunction which has not been sufficiently investigated until recently.

Conflict of Interest: None disclosed
Financial Support/Funding: Pfizer Australia
Sydney Australia, April 2007