To measure patient and partner satisfaction with vardenafil treatment for erectile dysfunction (ED) using the TSS.
Design and method
A randomised, double-blind, placebo-controlled, parallel-group multicentre comparison of the efficacy and safety of vardenafil. Study participants (n=229 couples) were men with ED >6 months duration and their untreated partners aged > /=18 years without sexual dysfunction (Female Sexual Function Index score >26.55). Couples completed both the TSS and mSLQQ-QoL; men also completed the IIEF-EF. Analysis of covariance produced least squares (LS) mean domain scores.
At LOCF, all TSS domain scores were significantly higher for vardenafil versus placebo for both patients (vardenafil vs placebo: ease with erection 61.18 vs. 35.01; erectile function satisfaction 53.17 vs. 10.48; pleasure from sexual activity 65.20 vs. 38.08; satisfaction with orgasm 60.81 vs. 27.82; confidence to complete sexual activity 59.70 vs. 26.01; satisfaction with medication 53.84 vs. 9.16; p<0.0001) and partners (vardenafil vs. placebo: ease with erection 60.93 vs. 30.83; erectile function satisfaction 53.22 vs. 16.88; pleasure from sexual activity 62.73 vs. 40.22; satisfaction with orgasm 61.10 vs. 37.19; confidence to complete sexual activity 57.57 vs. 20.93; satisfaction with medication 53.12 vs. 11.13; p<0.0001). For vardenafil-treated patients and their partners, correlations between TSS domain, IIEF-EF and mSLQQ-QoL scores at LOCF were moderate to strong.
The TSS detected that treatment satisfaction with vardenafil was superior to placebo from both patient and partner perspectives.
This study was supported financially by Bayer Healthcare.Le texte complet de cet article est disponible en PDF.