Volume 9, Issue 1 (January 2007) 9, 134–141; 10.1111/j.1745-7262.2007.00233.x
Improved spontaneous erectile function in men with mild-to-moderate arteriogenic erectile dysfunction treated with a nightly dose of sildenafil for one year: a randomized trial
Frank Sommer, Theodor Klotz and Udo Engelmann
1.Department of Men's Health, University Medical Center Hamburg-Eppendorf, Hamburg 20214, Germany
2.Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg 20214, Germany
3.Department of Urology, Klinikum Weiden, Weiden 92637, Germany
4..Department of Urology, University of Cologne, Cologne 50924, Germany
Correspondence: Dr Frank Sommer, University Medical Center Hamburg-Eppendorf, P. O. Box 202101, Hamburg 20214, Germany. Fax: +49-40-428-03-4734. E-mail: Frank.firstname.lastname@example.org
Received 3 May 2006; Accepted 30 July 2006.
Aim: To test the hypothesis that sildenafil (50 mg nightly for one year) can improve spontaneous erectile function (EF) in men with mild-to-moderate arteriogenic erectile dysfunction (ED) responsive to erectogenic treatment.
Methods: In a prospective open-label trial, 112 men with ED were randomized to sildenafil 50 mg nightly or sildenafil 50 or 100 mg as needed for 12 months, followed by one-month and 6-month non-medicated periods. Non-randomized, non-medicated men with ED were also assessed. The EF domain of the International Index of Erectile Function (IIEF EF) and the peak systolic velocity (PSV) of penile cavernous arteries were used to measure the efficacy.
Results: After sildenafil treatment and a subsequent non-medicated month, IIEF EF was normal in 29 of 48 (60.4%, 95% confidence interval [CI]: 45.3–74.2%) of the nightly group vs. 4 of 49 (8.2%, 95% CI: 2.3–19.6%) of the as-needed group. PSV improved by 11.2 cm/s (95% CI: 4.7–21.4; P = 0.012) in the nightly group but only by 3.4 cm/s (-5.1–14.7; P = 0.435) in the as-needed group. IIEF EF normalized in 1 of 18 (5.6%, 95% CI: 0.1–27.3%) non-medicated men and the PSV declined slightly. Six months after treatment, the IIEF EF remained normal and PSV was stabilized in most (28/29, 97%) nightly group men who had initially normalized.
Conclusion: Sildenafil nightly for one year resulted in ED regression that persisted well beyond the end of treatment, so that spontaneous EF was characterized as normal on the IIEF in most men. The results from this open-label, randomized trial warrant verification under double-blind, placebo-controlled conditions.
Keywords: phosphodiesterase, sexual dysfunctions, psychological, sildenafil citrate, erectile funcion
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