Randomized Controlled Double Blind Feasibility Trial of Tadalafil with Hydroxyurea Versus Hydroxyurea with Placebo for Secondary Prevention of Recurrent Priapism in Men with Sickle Cell Anemia: Pin Trial Final Results
Abstract
Background:
Recurrent ischemic priapism is a common complication of sickle cell anemia (SCA) with devastating sequelae of sexual dysfunction, reported at least once in 33% of men, with no evidence-based preventive treatment. Pre-clinical and observational studies with inadequate power have shown the potential benefits of phosphodiesterase-5 (PDE-5) inhibitors in preventing future priapism in transgenic mouse models and humans. Therefore, we hypothesized that a trial of PDE-5 inhibitor (tadalafil) for the prevention of priapism in men with SCA would be feasible, with an acceptable safety profile.
Methods:
We conducted a randomized, controlled, double-blind phase 2 feasibility trial to assess the composite primary outcome of recruitment, retention, and adherence rates of at least 75%. With a sample size of ³30 and an observed compliance rate of 83% and higher, we would obtain a lower bound of 75.6% or greater (above our lowest acceptable rate of 75% recruitment, retention, and adherence) using the Clopper-Pearson formula. The clinical outcomes were priapism rate (person-month), priapism pain intensity (1-5 Likert scale), priapism duration (minutes), and hospitalization for pain. The trial included men with SCA aged 18 to 40 years who had experienced a minimum of three priapism episodes, each lasting at least an hour, in the past 12 months, Figure 1. After satisfying the eligibility criteria and signing informed consent, the participants passed through a screening phase (2-4…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 84 participants or records.
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