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Erection hardness: a unifying factor for defining response in the treatment of erectile dysfunction.
Urology. 2006 Sep; 68(3 Suppl):17-25.U

Abstract

The extensive sildenafil citrate erectile dysfunction (ED) database of double-blind, placebo-controlled clinical trials was examined to determine the relation between erection hardness graded on the Erectile Hardness Grading Scale (EHGS) and (1) erectile function (EF), as assessed by the EF domain of the International Index of Erectile Function (IIEF); (2) frequency of erections hard enough for penetration, as assessed by IIEF Q2; and (3) the percentage of successful sexual intercourse attempts according to patient event logs. Pooled data from 6549 men with ED provided strong proof and improved characterization of the response to sildenafil. Almost half of men with ED and a baseline IIEF EF domain score classified as "severe ED" (< or = 10) shifted to a score classified as "no ED" (> or = 26). Sildenafil recipients showed greater mean improvement from baseline to end point in IIEF Q2 scores versus placebo, regardless of baseline ED severity, and a higher mean percentage of successful sexual intercourse attempts occurred during the last 4 weeks of treatment versus placebo (5.4-fold vs 2.0-fold increase from baseline). At end point, 95% of men who scored "no ED" on the IIEF EF domain and 92% of men who reported "almost always/always" achieving an erection hard enough for penetration (IIEF Q2) had graded their erections hard (rigid) enough for penetration (grade 3) or completely hard and fully rigid (grade 4) during the last 4 weeks of treatment, suggesting that the IIEF EF domain and IIEF Q2 may be good surrogate end points for erection hardness. Furthermore, during the last 4 weeks of treatment, the percentage of grade 3 and/or 4 erections correlated positively with the percentage of successful sexual intercourse attempts. Hence, hard erections may be considered a unifying factor that defines response to ED treatment. Completely hard and fully rigid erections (grade 4) should be recognized as the optimal goal of an ED therapy. Evidence presented here demonstrates that sildenafil significantly improved EF as assessed by the IIEF EF domain and assessments of erection hardness in patients with ED; a dose-response relation was observed in the proportions of men with ED who graded their erections hard (rigid) enough for sexual penetration or completely hard and fully rigid.

Authors+Show Affiliations

Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, New York 10021, USA. jpm2005@med.cornell.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

17011372

Citation

Mulhall, John P., et al. "Erection Hardness: a Unifying Factor for Defining Response in the Treatment of Erectile Dysfunction." Urology, vol. 68, no. 3 Suppl, 2006, pp. 17-25.
Mulhall JP, Levine LA, Jünemann KP. Erection hardness: a unifying factor for defining response in the treatment of erectile dysfunction. Urology. 2006;68(3 Suppl):17-25.
Mulhall, J. P., Levine, L. A., & Jünemann, K. P. (2006). Erection hardness: a unifying factor for defining response in the treatment of erectile dysfunction. Urology, 68(3 Suppl), 17-25.
Mulhall JP, Levine LA, Jünemann KP. Erection Hardness: a Unifying Factor for Defining Response in the Treatment of Erectile Dysfunction. Urology. 2006;68(3 Suppl):17-25. PubMed PMID: 17011372.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Erection hardness: a unifying factor for defining response in the treatment of erectile dysfunction. AU - Mulhall,John P, AU - Levine,Laurence A, AU - Jünemann,Klaus-Peter, PY - 2006/02/03/received PY - 2006/05/04/accepted PY - 2006/10/3/pubmed PY - 2006/10/20/medline PY - 2006/10/3/entrez SP - 17 EP - 25 JF - Urology JO - Urology VL - 68 IS - 3 Suppl N2 - The extensive sildenafil citrate erectile dysfunction (ED) database of double-blind, placebo-controlled clinical trials was examined to determine the relation between erection hardness graded on the Erectile Hardness Grading Scale (EHGS) and (1) erectile function (EF), as assessed by the EF domain of the International Index of Erectile Function (IIEF); (2) frequency of erections hard enough for penetration, as assessed by IIEF Q2; and (3) the percentage of successful sexual intercourse attempts according to patient event logs. Pooled data from 6549 men with ED provided strong proof and improved characterization of the response to sildenafil. Almost half of men with ED and a baseline IIEF EF domain score classified as "severe ED" (< or = 10) shifted to a score classified as "no ED" (> or = 26). Sildenafil recipients showed greater mean improvement from baseline to end point in IIEF Q2 scores versus placebo, regardless of baseline ED severity, and a higher mean percentage of successful sexual intercourse attempts occurred during the last 4 weeks of treatment versus placebo (5.4-fold vs 2.0-fold increase from baseline). At end point, 95% of men who scored "no ED" on the IIEF EF domain and 92% of men who reported "almost always/always" achieving an erection hard enough for penetration (IIEF Q2) had graded their erections hard (rigid) enough for penetration (grade 3) or completely hard and fully rigid (grade 4) during the last 4 weeks of treatment, suggesting that the IIEF EF domain and IIEF Q2 may be good surrogate end points for erection hardness. Furthermore, during the last 4 weeks of treatment, the percentage of grade 3 and/or 4 erections correlated positively with the percentage of successful sexual intercourse attempts. Hence, hard erections may be considered a unifying factor that defines response to ED treatment. Completely hard and fully rigid erections (grade 4) should be recognized as the optimal goal of an ED therapy. Evidence presented here demonstrates that sildenafil significantly improved EF as assessed by the IIEF EF domain and assessments of erection hardness in patients with ED; a dose-response relation was observed in the proportions of men with ED who graded their erections hard (rigid) enough for sexual penetration or completely hard and fully rigid. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/17011372/Erection_hardness:_a_unifying_factor_for_defining_response_in_the_treatment_of_erectile_dysfunction_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-4295(06)00767-9 DB - PRIME DP - Unbound Medicine ER -