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Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States.
J Urol. 2006 Mar; 175(3 Pt 1):1058-62.JU

Abstract

PURPOSE

We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR.

MATERIALS AND METHODS

This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment.

RESULTS

Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.8 +/- 4.2), the sildenafil group (128 patients, mean age +/- SD 56 +/- 12, mean years ED 4.6 +/- 4.3) had significantly greater improvements in all 5 SEAR components (p < 0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p < 0.0001), other IIEF domain scores (p < 0.0001), percentage of successful intercourse attempts (p < 0.0001) and frequency of erection that allowed satisfactory intercourse (p < 0.0001).

CONCLUSIONS

In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores.

Authors+Show Affiliations

Department of Surgery, Harvard Medical School, and Division of Urology, Brigham and Women's Hospital, Boston, Massachusetts 02115-6105, USA. moleary1@bics.bwh.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16469617

Citation

O'Leary, Michael P., et al. "Self-esteem, Confidence and Relationship Satisfaction of Men With Erectile Dysfunction Treated With Sildenafil Citrate: a Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study in the United States." The Journal of Urology, vol. 175, no. 3 Pt 1, 2006, pp. 1058-62.
O'Leary MP, Althof SE, Cappelleri JC, et al. Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. J Urol. 2006;175(3 Pt 1):1058-62.
O'Leary, M. P., Althof, S. E., Cappelleri, J. C., Crowley, A., Sherman, N., & Duttagupta, S. (2006). Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. The Journal of Urology, 175(3 Pt 1), 1058-62.
O'Leary MP, et al. Self-esteem, Confidence and Relationship Satisfaction of Men With Erectile Dysfunction Treated With Sildenafil Citrate: a Multicenter, Randomized, Parallel Group, Double-blind, Placebo Controlled Study in the United States. J Urol. 2006;175(3 Pt 1):1058-62. PubMed PMID: 16469617.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States. AU - O'Leary,Michael P, AU - Althof,Stanley E, AU - Cappelleri,Joseph C, AU - Crowley,Arthur, AU - Sherman,Nancy, AU - Duttagupta,Sandeep, AU - ,, PY - 2005/04/13/received PY - 2006/2/14/pubmed PY - 2006/3/31/medline PY - 2006/2/14/entrez SP - 1058 EP - 62 JF - The Journal of urology JO - J Urol VL - 175 IS - 3 Pt 1 N2 - PURPOSE: We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR. MATERIALS AND METHODS: This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment. RESULTS: Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.8 +/- 4.2), the sildenafil group (128 patients, mean age +/- SD 56 +/- 12, mean years ED 4.6 +/- 4.3) had significantly greater improvements in all 5 SEAR components (p < 0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p < 0.0001), other IIEF domain scores (p < 0.0001), percentage of successful intercourse attempts (p < 0.0001) and frequency of erection that allowed satisfactory intercourse (p < 0.0001). CONCLUSIONS: In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores. SN - 0022-5347 UR - https://www.unboundmedicine.com/medline/citation/16469617/Self_esteem_confidence_and_relationship_satisfaction_of_men_with_erectile_dysfunction_treated_with_sildenafil_citrate:_a_multicenter_randomized_parallel_group_double_blind_placebo_controlled_study_in_the_United_States_ L2 - https://www.jurology.com/doi/10.1016/S0022-5347(05)00418-0?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -