Combination of Tadalafil and Silodosin in the Treatment of Men with LUTS Associated with BPH
Introduction
Guidelines recommend both ?-1 blockers and phosphodiesterase type 5 inhibitors (PDE5-Is) as the first-line treatment in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). LUTS associated with BPH is likely to have an adverse impact on their quality of life. Furthermore, BPH can be complicated by damage to bladder function, bladder stones formation, hematuria, and impaired renal function. Tadalafil, a PDE5-I, is approved for the treatment of BPH. Silodosin, a third generation ?-1 blocker, improve short-term LUTS. However, their long-term effects have not been evaluated.
Aim
This study compares the efficacy of tadalafil alone, silodosin alone, and the combination of both in the treatment of LUTS associated with BPH.
Method
Study Design
- Prospective randomized study.
Patient Profile
- Men aged >50 years
- International prostate symptom score (IPSS) >8
- International index of erectile function (IIEF) score >12
- Maximum flow rate (Qmax) <10 ml/s
- Post-void residual (PVR) urine <200 cc
Treatment Strategy
- The cohort was randomized into 3 groups
- Group A received tadalafil, 5 mg for 3 months; n=101
- Group B received silodosin, 8 mg for 3 months; n=102
- Group C received the combination of tadalafil, 5 mg, and silodosin, 8 mg for 3 months; n=105
- All the men underwent physical examination, laboratory investigations, urinalysis, uroflowmetry and abdominal ultrasonography.
- Follow-up visits were scheduled after 2 weeks, 1, 2 and 3 months of treatment.
Endpoints
- IPSS
- IIEF score
- Qmax
- PVR
Results
- There were significant improvements in all the endpoints after 3 months of treatment as shown in Table 1.
|
| Group A Mean (+SD) | Group B Mean (+SD) | Group C Mean (+SD) | P value |
| ?Qmax | 7.2 (2.0) | 8.1 (2.3) | 8.7 (2.0) | <0.001 |
| ?IPSS | 3.6 (1.9) | 4.1 (2.2) | 5.6 (2.8) | <0.001 |
| ?IIEF | 5.9 (2.4) | 7.4 (2.1) | 7 (2.3) | <0.001 |
| ?PVR | 11.1 (7.1) | 13.3 (6.4) | 15.5 (6.4) | <0.001 |
- The mean Qmax, IPSS and IIEF values after 3 months of treatment are compared (all p<0.001) in Table 2.
|
| Group A | Group B | Group C |
| Mean Qmax (ml/sec) | 14.4 | 15.2 | 15.8 |
| Mean IPSS | 17.6 | 16.7 | 15.6 |
| Mean IIEF | 20.8 | 21.5 | 21.9 |
- Post-hoc analysis revealed that group C exhibited the best improvement in all the 4 endpoints.
- There were no significant differences in the incidence of complications among the 3 groups, except retrograde ejaculation with was higher in group C (9.5% vs 5.9% in group B).
Conclusion
- The lower urinary tract symptoms (LUTS) are significantly improved with either tadalafil 5 mg daily or silodosin 8 mg daily in men with LUTS associated with benign prostatic hyperplasia (BPH).
- However, the combination of both is more effective in improving the voiding symptoms and maximum flow rate in men with LUTS associated with BPH, with or without erectile dysfunction (ED).
World J Urol. 2022; 40(8): 2063–2070. Doi: 10.1007/s00345-022-04071-7.
