الفهرس 
Organogenesis and Development of the ProstateOnly 14 pages are availabe for public view
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Abstract
B
enign prostate hyperplasia (BPH) is a histological diagnosis which is identified by non-malignant hyperplasia of prostatic tissue due to smooth muscle and epithelial cell proliferation in the prostatic transition zone
The prevalence of histologically diagnosed prostatic hyperplasia increases from 8% in men aged 31 to 40 years old to 40-50% in men aged 51 to 60 years old. This increases to over 80% in men older than 80 years old. Older age is a risk factor for onset and progression of clinical BPH.
Benign prostatic hyperplasia (BPH) and erectile dysfunction (ED) are common geriatric diseases and their occurrence rate increases with the growth of age. Male patients with BPH not only suffer frequently from lower urinary tract symptoms (LUTS) (mainly including urination at night, interrupted urine flow, sense of incomplete bladder voiding and high-risk of acute urinary retention, etc) but also from ED and ejaculatory dysfunction, which have a greater unpleasant impact on the patient’s life.
In this study, we aimed to assess the efficacy and safety of fixed-dose of Tadalafil monotherapy versus its combination with Silodosin in treatment of BPH patient and erectile dysfunction (ED) by comparing IPSS score, PVR, Q max and the international Index of Erectile Function (IIEF questionnaire).
This prospective randomized control clinical study was conducted at tertiary care hospital at Ain Shams University hospitals and performed on total 60 men patients which were 45 years old or older with a history of LUTS secondary to BPH of at least 6 months.
The current study revealed that there was no statistically significant difference found between the studied groups regarding age of the studied patients (p= 0.751); while there was statistically significant increase in the total PSA in group A than group B.
Regarding IPSS and Q-max, our study results revealed that there was no statistically significant difference found between the studied groups regarding IPSS and Q-max at baseline while there was statistically significant difference found in IPSS and Q-max at 1 month, 2 months and 3 months, with statistically significant decrease in IPSS and significant increase in Q-max through follow-up from baseline in each group.
Consequently, there is a significant improvement in IPSS score change from baseline that found with combination therapy (group B) more than with Tadalafil alone (group A) after 3 months with a significant increase in Q-max change with combination therapy (group B) more than with Tadalafil alone (group A) after 3 months.
Regarding PVRU and IIEF score, our study results revealed that there was no statistically significant difference found between the studied groups regarding PVRU and IIEF score at baseline while there was statistically significant difference found only in PVRU at 1 month, 2 months and 3 months that showed significant decrease in group B, with statistically significant decrease in PVRU and significant increase in IIEF score through follow-up from baseline in each group.
Consequently, there is a significant decrease in PVRU from baseline that observed with combination therapy (group B) in comparison with using Tadalafil alone (group A) after 3 months with no significant change in IIEF score percentage among the studied groups.
Ultimately, there was better improvement with combination therapy compared to Tadalafil alone. The fixed-dose combinations of Silodosin 8 mg /day and Tadalafil 5 mg/day are significantly superior to Tadalafil 5 mg/day alone for the treatment of BPH patients with LUTS with no significant difference in treatment of ED in comparison to Tadalafil alone.
We concluded that the combination-therapy of tadalafil and Silodosin was more effective than tadalafil alone in improving subjective LUTS, but there was no significant improvement in sexual function.
Besides, the difference of total IPSS was mainly reflected in the change of IPSS voiding, which further proved that Silodosin might improve the total IPSS through relieving symptoms during urination.
We recommend combination regimen to be more effective compared with monotherapy of tamsulosin or tadalafil for LUTS improvement.
CONCLUSION
A
s evident from the current study, this analysis suggested that the combination-therapy of tadalafil and Silodosin was more effective than tadalafil alone in improving subjective LUTS, but there was no statistically significant IIEF improvement between both groups.
Besides, the difference of total IPSS was mainly reflected in the change of IPSS voiding, which further proved that Silodosin might improve the total IPSS through relieving symptoms during urination.
RECOMMENDATIONS
C
ombination regimen to be more effective compared with monotherapy of Silodosin or tadalafil for LUTS improvement.
Prospective, randomized, large placebo-controlled, long-lasting clinical trials with larger sample sizes are recommended to explain the role of combination therapy in patients with LUTS and ED with long-term follow up.