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Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase.
J Sex Med. 2008 Mar; 5(3):726-34.JS

Abstract

INTRODUCTION

Erectile dysfunction (ED) impacts erection hardness and compromises quality of life.

AIM

Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment).

METHODS

Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks).

MAIN OUTCOME MEASURES

Erection Hardness Score (EHS), Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF), Self-Esteem And Relationship (SEAR) questionnaire, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS).

RESULTS

A total of 307 men (mean [range] age, 45 [18-55] years) were randomized to sildenafil (N = 154) or placebo (N = 153). At the end of double-blind treatment, occasions with EHS 3 (hard enough for penetration but not completely hard) or 4 (completely hard) had increased by 40% +/- 3% for sildenafil vs. 11% +/- 3% for placebo (least squares mean +/- standard error; P < 0.0001); the estimated percentage of occasions with EHS 4 was 58% (95% CI, 52-65%) vs. 14% (95% CI, 10-19%) (odds ratio, 8.5; P < 0.0001). There was greater improvement in mean QEQ, IIEF, and SEAR scores (P < 0.0001), and more men were satisfied with sildenafil treatment (EDITS Index score >50: 90% vs. 49%). QEQ, IIEF, SEAR, and EDITS outcomes correlated positively with EHS 3 or 4, and with EHS 4 alone and were highest (no overlap of 95% CI vs. other EHS subgroups) in the subgroup with most frequent EHS of 4.

CONCLUSIONS

In the group of men with ED treated with sildenafil, it was estimated that completely hard erections were achieved on 58% (95% CI, 52-65%) of occasions. Improvement in function, emotional well-being, and satisfaction was greatest in men with completely hard erections and correlated positively with other measures of hardness.

Authors+Show Affiliations

Section of Andrology, Department of Urology, University of Istanbul, Istanbul, Turkey. itfabd@istanbul.edu.trNo 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18086165

Citation

Kadioglu, Ates, et al. "Quality of Erections in Men Treated With Flexible-dose Sildenafil for Erectile Dysfunction: Multicenter Trial With a Double-blind, Randomized, Placebo-controlled Phase and an Open-label Phase." The Journal of Sexual Medicine, vol. 5, no. 3, 2008, pp. 726-34.
Kadioglu A, Grohmann W, Depko A, et al. Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase. J Sex Med. 2008;5(3):726-34.
Kadioglu, A., Grohmann, W., Depko, A., Levinson, I. P., Sun, F., & Collins, S. (2008). Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase. The Journal of Sexual Medicine, 5(3), 726-34.
Kadioglu A, et al. Quality of Erections in Men Treated With Flexible-dose Sildenafil for Erectile Dysfunction: Multicenter Trial With a Double-blind, Randomized, Placebo-controlled Phase and an Open-label Phase. J Sex Med. 2008;5(3):726-34. PubMed PMID: 18086165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quality of erections in men treated with flexible-dose sildenafil for erectile dysfunction: multicenter trial with a double-blind, randomized, placebo-controlled phase and an open-label phase. AU - Kadioglu,Ates, AU - Grohmann,Walther, AU - Depko,Andrzej, AU - Levinson,Ivan P, AU - Sun,Franklin, AU - Collins,Suzanne, Y1 - 2007/12/17/ PY - 2007/12/19/pubmed PY - 2008/4/11/medline PY - 2007/12/19/entrez SP - 726 EP - 34 JF - The journal of sexual medicine JO - J Sex Med VL - 5 IS - 3 N2 - INTRODUCTION: Erectile dysfunction (ED) impacts erection hardness and compromises quality of life. AIM: Assess erection hardness and its correlation with sexual function, emotional well-being, and satisfaction (erection quality, intercourse, sex life, sexual relationship, and treatment). METHODS: Men with ED were randomized to double-blind, flexible-dose sildenafil (25, 50, or 100 mg) or placebo (6 weeks) with open-label extension (6 weeks). MAIN OUTCOME MEASURES: Erection Hardness Score (EHS), Quality of Erection Questionnaire (QEQ), International Index of Erectile Function (IIEF), Self-Esteem And Relationship (SEAR) questionnaire, and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS). RESULTS: A total of 307 men (mean [range] age, 45 [18-55] years) were randomized to sildenafil (N = 154) or placebo (N = 153). At the end of double-blind treatment, occasions with EHS 3 (hard enough for penetration but not completely hard) or 4 (completely hard) had increased by 40% +/- 3% for sildenafil vs. 11% +/- 3% for placebo (least squares mean +/- standard error; P < 0.0001); the estimated percentage of occasions with EHS 4 was 58% (95% CI, 52-65%) vs. 14% (95% CI, 10-19%) (odds ratio, 8.5; P < 0.0001). There was greater improvement in mean QEQ, IIEF, and SEAR scores (P < 0.0001), and more men were satisfied with sildenafil treatment (EDITS Index score >50: 90% vs. 49%). QEQ, IIEF, SEAR, and EDITS outcomes correlated positively with EHS 3 or 4, and with EHS 4 alone and were highest (no overlap of 95% CI vs. other EHS subgroups) in the subgroup with most frequent EHS of 4. CONCLUSIONS: In the group of men with ED treated with sildenafil, it was estimated that completely hard erections were achieved on 58% (95% CI, 52-65%) of occasions. Improvement in function, emotional well-being, and satisfaction was greatest in men with completely hard erections and correlated positively with other measures of hardness. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/18086165/Quality_of_erections_in_men_treated_with_flexible_dose_sildenafil_for_erectile_dysfunction:_multicenter_trial_with_a_double_blind_randomized_placebo_controlled_phase_and_an_open_label_phase_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)31981-0 DB - PRIME DP - Unbound Medicine ER -