Arthur L Burnett1, Uzoma A Anele2, Irene N Trueheart2, John J Strouse3, James F Casella3. 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.
RCT Entities:
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.
Authors: Drogo K Montague; Jonathan Jarow; Gregory A Broderick; Roger R Dmochowski; Jeremy P W Heaton; Tom F Lue; Ajay Nehra; Ira D Sharlip Journal: J Urol Date: 2003-10 Impact factor: 7.450
Authors: R Berger; K Billups; G Brock; G A Broderick; C B Dhabuwala; I Goldstein; L S Hakim; W Hellstrom; S Honig; L A Levine; T Lue; R Munarriz; D K Montague; J J Mulcahy; A Nehra; Z R Rogers; R Rosen; A D Seftel; R Shabsigh; W Steers Journal: Int J Impot Res Date: 2001-12 Impact factor: 2.896
Authors: Gwen Lagoda; Sena F Sezen; K Joseph Hurt; Marcelo R Cabrini; Dillip K Mohanty; Arthur L Burnett Journal: FASEB J Date: 2013-09-27 Impact factor: 5.191
Authors: Trinity J Bivalacqua; Biljana Musicki; Lewis L Hsu; Dan E Berkowitz; Hunter C Champion; Arthur L Burnett Journal: PLoS One Date: 2013-07-02 Impact factor: 3.240
Authors: Nikolai A Sopko; Hotaka Matsui; Johanna L Hannan; Dan Berkowitz; Hunter C Champion; Lewis L Hsu; Biljana Musicki; Arthur L Burnett; Trinity J Bivalacqua Journal: J Sex Med Date: 2015-09-07 Impact factor: 3.802