ORIGINAL RESEARCH—ED PHARMACOTHERAPY: The Treatment Satisfaction Scale (TSS) is a Sensitive Measure of Treatment Effectiveness for both Patients and Partners: Results of a Randomized Controlled Trial with Vardenafil

Abstract

ABSTRACT Introduction Erectile dysfunction (ED) treatment studies do not routinely measure “treatment effectiveness,” a function of treatment response (based on efficacy and tolerability) and treatment satisfaction (both patient and partner satisfaction). The ED Treatment Satisfaction Scale (TSS) is a brief, comprehensive self-report measure of patient and partner satisfaction. Aim To measure, for the first time in an ED treatment study, pre- and post-treatment patient and partner satisfaction with the TSS. Methods A randomized, double-blind, placebo-controlled, parallel-group, multi-institutional comparison of the efficacy and safety of flexible-dose vardenafil was performed in 229 couples (treated man with ED >6 months and untreated woman partner aged ≥18 years without sexual dysfunction [defined as a total Female Sexual Function Index score >26.55]). Main Outcome Measures Couples completed the TSS throughout the trial. Couples also completed the modified Sexual Life Quality Questionnaire–Quality of Life domain (mSLQQ-QoL) and men completed the International Index of Erectile Function-erectile function domain (IIEF-EF). Analysis of covariance produced least squares (LS) mean domain scores. Post hoc Pearson correlation coefficients were calculated for patient and partner TSS scores, and for TSS scores with other outcomes. Results TSS domain scores increased from baseline to last observation carried forward (LOCF) in the vardenafil-treated men and untreated women partners, but exhibited little change for the placebo group (P < 0.0001 vs. placebo). For both patients and partners in the vardenafil group, correlations between TSS domains, the IIEF-EF and the mSLQQ-QoL scores at LOCF were moderate to strong. Conclusions The TSS detected that vardenafil was superior to placebo on treatment satisfaction from both patient and partner perspectives. The TSS holds promise for evaluating “treatment effectiveness” by measuring more general treatment satisfaction.