Quality of life assessment in sexual dysfunction trials

Quality of Life (QOL) is an important outcome dimension in clinical trials of sexual dysfunction. This brief paper reviews the rationale for inclusion of QOL measures in clinical trials and considers the use of broad-based or generic measures of QOL, compared to disease-specific measures. Two disease-specific measures of QOL associated with erectile dysfunction are presented in detail. Each of these measures has certain advantages, although neither has been sufficiently validated to warrant large-scale use in clinical trials. Further research is needed, particularly on the impact of sexual dysfunction on QOL in women.