Conditions: Sickle Cell Disease Priapism
Keywords: priapism sickle cell disease sildenafil phosphodiesterase type 5 inhibitor
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 13
Healthy volunteers: no

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 description:
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.

Arms:
arm 1: Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. arm 2: Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.

Interventions: intervention 1: sildenafil intervention 2: placebo
Intervention descriptions: intervention 1: sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2) intervention 2: placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)

Protocol document: