The effect of tadalafil on psychosocial outcomes in Swedish men with erectile distress: a multicentre, non-randomised, open-label clinical study.

A multicentre, non-randomised, open-label study assessed whether personal distress caused by erectile dysfunction (ED) affected psychosocial outcomes of tadalafil treatment. Eligible Swedish men at least 18 years old reporting > or =3-month history of ED were stratified into two groups (manifest or mild/no distress) based upon a distress question administered at enrollment. Tadalafil 20 mg was taken as needed for 8 weeks. The primary outcome was the difference between the two distress groups in change from baseline in the Psychological and Interpersonal Relationship Scales (PAIRS) spontaneity domain. Secondary outcome measures were PAIRS sexual self-confidence and time concerns domains, Life Satisfaction (LiSat-11) checklist and a Global Assessment of Treatment Response. The study also assessed tolerability. Of 662 men enrolled, 88% had manifest distress and 12% had mild/no distress. Baseline-to-endpoint changes for PAIRS domains were not significantly different between groups. Baseline-to-endpoint changes in LiSat-11 items were not significantly different between groups except for satisfaction with sexual life. Compared with men without ED, below normal baseline satisfaction with partner relationship and family life were normalised at endpoint. Over 90% of men reported improved erection and ability to engage in sexual activity. The most common treatment-emergent adverse events were headache, myalgia, dyspepsia, flushing and back pain. One man discontinued because of myalgia; 630 (95%) completed the study. In conclusion, erectile distress levels vary among patients with ED and distress can affect intra-familiar aspects of life, which may have implications for clinical practise. However, distress does not appear to hinder improvement in both mechanical and psychosocial outcomes of tadalafil treatment.