Effect of tadalafil 5 mg on post‐micturition dribble in men with lower urinary tract symptoms: a multicentre, double‐blind, randomized, placebo‐controlled trial

Abstract

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.

Efficacy and Safety of 12-week Monotherapy With Once Daily 5 mg Tadalafil for Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: Evidence-based Analysis

“…A total of 1,425 relevant articles were extracted from the databases through systematical and manual search strategies. Eventually, 13 articles ( 15 – 27 ) involving 9,525 participants were identified, of which 15 trials that met the eligibility criteria were included in this study. While the follow-up period was different in each study, we pooled data of the change from baseline to 12 weeks from the studies.…”

“…The total IPSS, IPSS voiding subscore, and IPSS storage subscore were reported in all the trails we selected. The data pooled from 15 studies ( 15 – 27 ) including 9,525 participants (4,937 and 4,588 in the tadalafil and placebo groups, respectively), and provided the necessary information for this study. The subsequent analysis result revealed a significantly larger total IPSS change from the baseline to 12 weeks in the tadalafil group (MD: −1.97 95% CI: −2.24 to −1.70, P < 0.00001, Figure 3A ) than in the placebo group.…”

“…A total of 15 studies ( 15 – 27 ) included in the analysis recorded the change in the IPSS voiding and storage subscores from baseline to 12 weeks. The analysis of the combined data showed that tadalafil significantly reduced the IPSS voiding and storage subscores more than the placebo did, and the MD of the change in the two subscores was −1.30 (95% CI: −1.48 to −1.11, P < 0.00001, Figure 3B ) and −0.70 (95% CI: −0.82 to −0.58, P < 0.00001, Figure 3C ), respectively.…”

“…The AEs and SAEs that occurred in the tadalafil and placebo groups were compared in this review. All the studies included (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27) in the analysis reported the incidence of AEs, which showed a significant difference between the tadalafil and placebo groups with a RR of 1.27 (95% CI: 1.19-1.36, P < 0.00001, Figure 5A). However, the comparison of incidences of SAE did not show any significant difference between the two groups (RR: 1.27, 95% CI: 0.80-2.01, P = 0.31, Figure 5B) in the 13 studies including 8,436 participants (4,393 and 4,043 in the tadalafil and placebo groups, respectively).…”

Should All Men with Type 2 Diabetes Be Routinely Prescribed a Phosphodiesterase Type 5 Inhibitor?

“…One RCT showed significant improvement with tadalafil 5 mg daily in the bothersome symptom of post-micturition dribble, whereas tamsulosin has proved ineffective [58]. Studies suggest a synergistic effect with tadalafil in combination with tamsulosin, and, for larger prostates with finasteride.…”