Open AccessSelf‐Esteem, Confidence, and Relationships in Men Treated with Sildenafil Citrate for Erectile Dysfunction: Results of Two Double‐blind, Placebo‐controlled Trials
Author(s) -
Althof Stanley E.,
O' Leary Michael P.,
Cappelleri Joseph C.,
Glina Sidney,
King Rosie,
Tseng LiJung,
Bowler Jessica L.
Publication year - 2006
Publication title -
journal of general internal medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.746
H-Index - 180
eISSN - 1525-1497
pISSN - 0884-8734
DOI - 10.1111/j.1525-1497.2006.00554.x
Subject(s) - medicine , erectile dysfunction , sildenafil , psychosocial , placebo , confidence interval , sexual intercourse , sexual function , patient satisfaction , sexual desire , population , psychiatry , surgery , human sexuality , gender studies , alternative medicine , environmental health , pathology , sociology
BACKGROUND: Men with erectile dysfunction (ED) often have low self‐esteem, confidence, and sexual relationship satisfaction. OBJECTIVE: We evaluated the impact of sildenafil citrate and its generalizability across cultures on self‐esteem, confidence, and sexual relationship satisfaction in men with ED using the Self‐Esteem And Relationship (SEAR) questionnaire. DESIGN: Pooled analysis of 2 double‐blind, placebo‐controlled, flexible‐dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan. PATIENTS: Men ≥18 years old with ED. MEASUREMENTS: The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes. RESULTS: Compared with patients who received placebo ( n =274), patients who received sildenafil ( n =279) reported significantly greater improvements ( P <.0001) in self‐esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P <.0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy. CONCLUSIONS: In men with ED from 5 different nations, sildenafil produced substantial improvements in self‐esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.