Objectives: To compare the effects of taking tadalafil 5 mg and placebo once daily on post-micturition dribble (PMD) in men with lower urinary tract symptoms (LUTS). Patients and Methods: Our prospective, randomized, double-blind, placebo-controlled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym Post-Micturition Dribble Questionnaire (HPMDQ) and according to PMD volume. Over a 12-week period, patients took either tadalafil 5 mg (n = 51) or placebo (n = 51) once daily and their HPMDQ and PMD volume results were evaluated. Adverse events (AEs) were also reported. Results: Over the course of 12 weeks, total HPMDQscores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score of ≥2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients (P < 0.001) and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22 mL, respectively (P = 0.046). Specifically, PMD frequency decreased and quality of life increased significantly more in the tadalafil group than in the placebo group (P = 0.029 and P < 0.001, respectively). Furthermore, 66.7% of the tadalafil group reported moderate and significant PMD improvement, whereas only 4.2% reported that tadalafil was ineffective. Treatment-emergent AEs did not significantly differ between the groups (all P > 0.05), and no serious AEs were observed. Conclusion: Taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD, without inducing serious AEs, more effectively than placebo, suggesting that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment.
Bibliographical noteFunding Information:
This research was supported by a grant from Chong Kun Dang Pharmaceutical Corp., Seoul, Korea. The study was approved by the Korean Ministry of Food and Drug Safety (KMFDS; file no. 31252-2017) and the respective institutional ethical committees of the participating institutions (file no. 16-12-003 at KSHH, 2016-602-I at DSHH, and 2016-137 at CSHH).
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- lower urinary tract symptoms
- phosphodiesterase-5 inhibitors
- post-micturition dribble