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Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebocontrolled 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
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, placebocontrolled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym PostMicturition 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.
In conclusion, taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD and other LUTS more effectively than placebo. The present results also show that tadalafil does not induce serious TEAEs. These results suggest that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment, and suggest that PDE-5 inhibitors have a potential role in treating PMD.
Dae Yul Yang*, Hyun Cheol Jeong*, Kyungtae Ko*, Seong Ho Lee† , Sang Kon Lee‡ , Tae Young Shin‡ , Jin Seon Cho§ and Won Ki Lee
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, placebocontrolled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym PostMicturition 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.
In conclusion, taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD and other LUTS more effectively than placebo. The present results also show that tadalafil does not induce serious TEAEs. These results suggest that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment, and suggest that PDE-5 inhibitors have a potential role in treating PMD.
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