The research was conducted to evaluate overall safety and efficacy of new medication, assess the quality of life outcomes related to nocturia, examine the average number of voids per night and hours of sleep, and investigate effect of the drug on the first uninterrupted sleep period.
Subjects who reported nocturia, but didn’t have urinary tract infections, increased post residual volume (PVR), neurologic or sleep comorbidities were enrolled into 4 arms, double-blind, Phase 2 study. 80 patients have completed 2 weeks of treatment with low, medium, or large dose of Paxerol, or placebo.
The study showed that treatment groups had a statistically significant reduction in nocturic episodes compared to the placebo group (Figure 1).
Figure 1
While there were no remarkable changes in the overall hours of sleep, subjects from the high dose group reported a significant increase in the first uninterrupted sleep period. In addition, all 4 groups showed an increase in nocturia-related quality of life (Figure 2)
Figure 2
While trial had promising results, expert panel participants pointed out that it would be beneficial to evaluate long-term use of Paxerol since ibuprofen can lead to negative upper urinary tract outcomes.
Presented by: Mahyar Kashan, MD, Downstate College of Medicine, Brooklyn, NY
Co-authors: Khusid J A, Weiss J P, Rauscher F, Blair B, Efros M, Kaminesky J, Contreras J, Rydin I, Xie L, Whisnant J, Lee K
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania, @PennUrology at the 2018 ICS International Continence Society Meeting - August 28 - 31, 2018 – Philadelphia, PA USA