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Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension.
Int J Clin Pract. 2007 Nov; 61(11):1843-9.IJ

Abstract

AIMS

To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

METHODS

This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score.

RESULTS

At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated.

CONCLUSIONS

In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated.

Authors+Show Affiliations

Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, IL 60611-3008, USA. k-mcvary@northwestern.eduNo 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

17887993

Citation

McVary, K T., et al. "Sildenafil Citrate Improves Erectile Function: a Randomised Double-blind Trial With Open-label Extension." International Journal of Clinical Practice, vol. 61, no. 11, 2007, pp. 1843-9.
McVary KT, Kaufman J, Young JM, et al. Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. Int J Clin Pract. 2007;61(11):1843-9.
McVary, K. T., Kaufman, J., Young, J. M., & Tseng, L. J. (2007). Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. International Journal of Clinical Practice, 61(11), 1843-9.
McVary KT, et al. Sildenafil Citrate Improves Erectile Function: a Randomised Double-blind Trial With Open-label Extension. Int J Clin Pract. 2007;61(11):1843-9. PubMed PMID: 17887993.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sildenafil citrate improves erectile function: a randomised double-blind trial with open-label extension. AU - McVary,K T, AU - Kaufman,J, AU - Young,J M, AU - Tseng,L-J, Y1 - 2007/09/20/ PY - 2007/9/25/pubmed PY - 2008/4/15/medline PY - 2007/9/25/entrez SP - 1843 EP - 9 JF - International journal of clinical practice JO - Int J Clin Pract VL - 61 IS - 11 N2 - AIMS: To evaluate once-daily 100-mg sildenafil for the treatment of erectile dysfunction (ED) in men with ED and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). METHODS: This was a 12-week, randomised, double-blind, placebo-controlled (DBPC) trial, with an 8-week open-label (OL) extension, in men > or = 45 years of age who scored < or = 25 on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and > or = 12 on the International Prostate Symptom Score. RESULTS: At DBPC end of treatment (EOT), the sildenafil group (n = 189, vs. placebo, n = 180) had improved EF (IIEF), improved emotional well-being [Self-Esteem And Relationship questionnaire (SEAR)], and greater treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction) (p < 0.0001). At OL EOT, IIEF and SEAR scores improved slightly in the group previously randomised to sildenafil (n = 168), but much more in the group previously randomised to placebo (N = 155), such that total improvement over the 20-week trial was comparable between the groups. Erections at baseline were hard enough for penetration on approximately half of occasions and lasted long enough for successful intercourse on less than one quarter of occasions, increasing at sildenafil DBPC and OL EOT to approximately 90% (penetration) and 80% (intercourse success) vs. 61% (penetration) and 39% (intercourse success) for DBPC placebo. At sildenafil DBPC and OL EOT, > or = 90% of men were taking sildenafil 100 mg. Sildenafil was generally well tolerated. CONCLUSIONS: In this trial of men with ED and BPH-associated LUTS, sildenafil treatment for ED was efficacious, effective and generally well tolerated. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/17887993/Sildenafil_citrate_improves_erectile_function:_a_randomised_double_blind_trial_with_open_label_extension_ L2 - https://doi.org/10.1111/j.1742-1241.2007.01585.x DB - PRIME DP - Unbound Medicine ER -