The effect of tadalafl and dutasteride combination on lower urinary system symptoms and erectile functions in patients with and without prostate median lobe

Abstract Introduction Alpha blockers, 5 alpha reductase inhibitors, anticholinergics and tadalafil are used in the treatment of LUTS due to BPH. Objective The aim of this study was to evaluate the effect of daily tadalafil+dutasteride treatment on lower urinary tract symptoms (LUTS) and erectile functions in male patients with and without a median prostate lobe. Methods Male patients over the age of 40 who applied to the Urology Outpatient Clinic due to LUTS/ED between January 2018 and December 2022 were included in the study. Ethics committee approval was obtained for the study. Detailed medical and sexual histories of the patients were taken. The International Prostate Symptom Index was used for the LUTS, and the International Erectile Function Index-Erectile Function section was used for the erectile function. PSA and total testosterone levels of the patients were recorded. Maximum urine flow rate (Qmax) was measured by uroflowmetry. Prostate volume, presence of median lobe, median lobe volume and post-void residual urine volume (PMR) were measured by transabdominal ultrasound. Then, patients with moderate and severe LUTS and prostate volume over 40 cc were divided into 2 groups as those with and without middle lobe. The patients were started on tadalafil 5mg and dutasteride 0.5mg daily. IPSS, IIEF-EF, Qmax, PV and PMR changes of the patients were compared after 24 weeks of treatment. Results A total of 96 patients were included in the study (42 with a median lobe (group-1), 54 without a median lobe (group-2). The mean age of the patients was 56.25±13.47, and the mean BMI was 29.12±7.76. The mean IPSS value of the patients was 14.25±6.69, and the IIEF-EF value was 12.11±9.93. Mean PSA value 2.25±1.36 ng/ml, total testosterone value 345.67±123.21 ng/ml, mean PV 46.71±23.22 ml, Qmax value 8.24±3.36 m/s, PVR 54.32±25.52 was ml. There was no significant difference between the baseline IPSS, IIEF-EF, PSA and Qmax values between the two groups (p>0.05). After daily tadalafil+dutasteride treatment, mean IPSS value of the patients at the 24th week controls was 5.42±4.09 (p<0.001), IIEF-EF score was 20.97±3.67p<0.001), PV was 38.20±10.68 ml (p= 0.021), the Qmax value was found to be 12.45±7.68 m/s (p<0.001). Significant improvements were observed in IPSS, IIEF-EF and Qmax values in both groups compared to the beginning of treatment when the parameters of the groups were changed at the beginning and at the 24th week. When the 24th week data of the two groups were compared, it was found that the IPSS decrease in group-2 was higher than in group-1 (p=0.012). IIEF-EF scores (p=0.034) and Qmax (p=0.001) values were found to be higher than group-1. Conclusions Daily tadalafil+dutasteride treatment is an effective and safe treatment combination in male patients with LUTS/ED. In the presence of the median lobe, the response from tadalafil+dutasteride treatment decreases. The 24-week preliminary results of the study allowed us to have an idea of the long-term results. Further studies are needed to evaluate the effect of tadalafil+dutasteride combination in the treatment of LUTS/ED. Disclosure No