Clinical Trial: Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Brief Summary: This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).
Detailed Summary: The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.
Sponsor: Johns Hopkins University
Current Primary Outcome:
- Greater Than or Equal to a 50% Reduction in Priapic Episodes [ Time Frame: change between baseline and 8 weeks post intervention ]A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.
- Greater Than or Equal to a 50% Reduction in Priapic Episodes [ Time Frame: change between 8 weeks post intervention and 16 weeks post intervention ]A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes.
Original Primary Outcome: Our primary outcome is the proportion of patients having a reduction in frequency of priapism in one category of the Priapism/Sexual Activity Log averaged over the final four weeks of the treatment period. [ Time Frame: 8 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Mean number of weekly episodes of priapism in the first and second 4 weeks of the treatment period [ Time Frame: 8 weeks ]
Information By: Johns Hopkins University
Dates:
Date Received: July 16, 2009
Date Started: June 2008
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017
