1. ¹Department of Urology, Case Medical Center/University Hospitals of Cleveland, Cleveland, OH, USA
2. ²CETPARP, Lille, France
3. ³Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA
4. ⁴Medical Affiliated Research Center, Huntsville, AL, USA
5. ⁵Lilly USA, LLC, Lilly Corporate Center, Indianapolis, IN, USA

Correspondence: Dr AD Seftel, Department of Urology, Case Medical Center, 11100 Euclid Avenue, Suite 1210, University Hospitals of Cleveland, Cleveland, OH 44106, USA. E-mail: allen.seftel@case.edu

Received 5 January 2009; Revised 23 March 2009; Accepted 27 April 2009; Published online 18 June 2009.

Abstract

An efficacy study of tadalafil (5 mg once daily) for treating erectile dysfunction included sexual satisfaction and psychosocial outcome measures such as Treatment satisfaction (THX) domain of Sexual Life Quality Questionnaire, Self-Esteem And Relationship (SEAR) questionnaire, Sexual Encounter Profile questions 4 (SEP4; hardness satisfaction) and 5 (SEP5; overall satisfaction), intercourse satisfaction (IS) and overall satisfaction (OS) domains of International Index of Erectile Function (IIEF), and partner SEP question 3 (pSEP3). After a 4-week run-in phase, participants were randomized to receive either tadalafil (N=264) or placebo (N=78) for 12 weeks. Participants and partners were more satisfied (THX) with tadalafil (75 and 73, respectively) than with placebo (51 and 55, respectively, P<0.001). Statistically significant improvements in sexual relationship, confidence, self-esteem and overall relationship (SEAR), in addition to IS, OS, SEP5 and pSEP3 for tadalafil compared with placebo (P<0.001) correlated with erectile function (EF) improvement (assessed by change from baseline in IIEF-EF score). Tadalafil significantly improved treatment and sexual satisfaction, while improving multiple outcomes measured by SEAR.