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Am J Med. 2014 Jul;127(7):664-8. doi: 10.1016/j.amjmed.2014.03.019. Epub 2014 Mar 25.

Randomized controlled trial of sildenafil for preventing recurrent ischemic priapism in sickle cell disease.

Author information

1
The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, Md. Electronic address: aburnet1@jhmi.edu.
2
The James Buchanan Brady Urological Institute and Department of Urology, The Johns Hopkins School of Medicine, Baltimore, Md.
3
Division of Pediatric Hematology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.

Abstract

BACKGROUND:

Successful preventive therapy for ischemic priapism, a disorder of penile erection with major physical and psychologic consequences, is limited. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease.

METHODS:

Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily, unassociated with sleep or sexual activity, for 8 weeks, followed by open-label use of this sildenafil regimen for an additional 8 weeks.

RESULTS:

Priapism frequency reduction by 50% did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses (P = 1.0). However, during open-label assessment, 5 of 8 patients (62.5%) by intention-to-treat analysis and 2 of 3 patients (66.7%) by per protocol analysis met this primary efficacy outcome. No significant differences were found between study groups in rates of adverse effects, although major priapism episodes were decreased 4-fold in patients monitored "on-treatment."

CONCLUSIONS:

Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease.

KEYWORDS:

Erectile dysfunction; Erection; Nitric oxide; Phosphodiesterase type 5

PMID:
24680796
PMCID:
PMC4085689
DOI:
10.1016/j.amjmed.2014.03.019
[Indexed for MEDLINE]
Free PMC Article

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