title: Enhanced understanding of the relationship between erection and satisfaction in ED treatment: application of a longitudinal mediation model.
abstract: To apportion the direct effect and the indirect effect (through erections) that sildenafil (vs placebo) has on individual satisfaction and couple satisfaction over time, longitudinal mediation modeling was applied to outcomes on the Sexual Experience Questionnaire. The model included data from weeks 4 and 10 (double-blind phase) and week 16 (open-label phase) of a controlled study. Data from 167 patients with erectile dysfunction (ED) were available for analysis. Estimation of statistical significance was based on bootstrap simulations, which allowed inferences at and between time points. Percentages (and corresponding 95% confidence intervals) for direct and indirect effects of treatment were calculated using the model. For the individual satisfaction and couple satisfaction domains, direct treatment effects were negligible (not statistically significant) whereas indirect treatment effects via the erection domain represented >90% of the treatment effects (statistically significant). Week 4 vs week 10 percentages of direct and indirect effects were not statistically different, indicating that the mediation effects are longitudinally invariant. As there was no placebo arm in the open-label phase, mediation effects at week 16 were not estimable. In conclusion, erection has a crucial role as a mediator in restoring individual satisfaction and couple satisfaction in men with ED treated with sildenafil.
authors.affiliation: Pfizer, Statistics, Groton, CT, USA.
authors.forename: A G
authors.initials: AG
authors.lastname: Bushmakin
authors.affiliation: Pfizer, Statistics, Groton, CT, USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Cappelleri
authors.affiliation: Market Access, Primary Care Business Unit, Pfizer Ltd, Surrey, Kent, UK.
authors.forename: T
authors.initials: T
authors.lastname: Symonds
authors.affiliation: Pfizer, New York, NY, USA.
authors.forename: V J
authors.initials: VJ
authors.lastname: Stecher
mesh_terms: D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects / Q000523:psychology*; D010549:Personal Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D010879:Piperazines / Q000494:pharmacology / Q000627:therapeutic use*; D011687:Purines / Q000494:pharmacology / Q000627:therapeutic use; D012747:Sexual Partners / Q000523:psychology*; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000494:pharmacology / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate