Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebo- controlled trial Dae Yul Yang*, Hyun Cheol Jeong*, Kyungtae Ko*, Seong Ho Lee † , Sang Kon Lee ‡ , Tae Young Shin ‡ , Jin Seon Cho § and Won Ki Lee ‡ *Department of Urology, College of Medicine, Kangdong Sacred Heart Hospital, Hallym Unversity, Seoul, † Department of Urology, College of Medicine, Dongtan Sacred Heart Hospital, Hallym Unversity, Hwaseong, ‡ Department of Urology, College of Medicine, Chuncheon Sacred Heart Hospital, Hallym Unversity, Chuncheon, and § Department of Urology, College of Medicine, Hallym University Sacred Heart Hospital, Hallym Unversity, Anyang, Korea This trial was registered at International Clinical Trials Registry Platform (ICTRP; www.who.int/ictrp; file no. KCT0002232). 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. Keywords lower urinary tract symptoms, men, phosphodiesterase-5 inhibitors, post-micturition dribble Introduction It is possible to divide LUTS into storage, voiding and post- micturition symptoms [1]; however, almost all LUTS treatments are focused on storage and voiding symptoms, not on post-micturition symptoms [1,2], and even LUTS research does not focus on post-micturition symptoms. Physicians’ and researchers’ indifference to post-micturition symptoms may be attributable to the traditional belief that post- micturition symptoms may be a part of the aging process, have a low prevalence, and elicit less discomfort than other LUTS [3–7]. Post-micturition dribble (PMD), a post-micturition symptom, is defined as an involuntary loss of urine immediately after passing urine [2]. It is clearly different from terminal dribble, which is a voiding symptom [2]. PMD occurs in both genders, but seems to be more common in men [6,8]. Contrary to traditional assumptions [3–6], recent evidence © 2019 The Authors BJU Int 2019; 124: 862–869 BJU International © 2019 BJU International | doi:10.1111/bju.14849 wileyonlinelibrary.com Published by John Wiley & Sons Ltd. www.bjui.org Functional Urology