Introduction. The alfuzosin and solifenacin combination has previously demonstrated high efficacy and safety in patients with BPH and overactive bladder (OAB), including with severe LUTS, if cases of mechanical type of bladder outlet obstruction (BOO) were excluded. The present study aim was to confirm the efficacy and safety of such combination therapy in patients with severe urinary disorders according to uroflowmetry (UFM).
Materials and methods. The observational multicenter AVIATOR study included 208 men with BPH and OAB. Its unique features were: the use of alfuzosin (Alfuprost® MR, 10 mg/day) and solifenacin (Vesigamp, 5 mg/day) combination for 3 months in patients with moderate to severe LUTS; intravesical prostatic protrusion ≥ 10 mm as exclusion criteria; comprehensive assessment of symptoms dynamics by IPSS/QoL, OABSS, PPIUS questionnaires; initial stratification of patients subgroups by Qmax; assessment of changes by UFM report and curve; evaluation of treatment efficacy by «clinically significant response» achieving.
Results. Initially, patients were divided into two subgroups, depending on Qmax index: PG1 with Qmax < 12 ml/day (n=102); PG2 with Qmax ≥ 12 ml/day (n=106). PG1 and PG2 patients did not significantly differ in average age (60.2 and 61.3 years) and anthropometric data, but statistically differed in prostate volume (52.1+13.3 and 47.7+10.3 cm cc), total IPSS score, voiding symptoms (IPSS-v), OABSS and UFM parameters. At the same time, there were no significant differences in filling phase symptoms (IPSS-s), including nocturia, QoL, and PPIUS urgency. As a result of treatment, after one and three months, the patients majority in PG1 and PG2 achieved statistically significant improvement in most subjective and objective clinical indicators, respectively: IPSS by 45.2% and 70.5% versus 46.0% and 74.3%; IPSS-s by 42.7% and 70.1% vs. 47.2% and 74.7%; IPSS-v by 45.8% and 70.0% vs. 44.8% and 74.0%; QoL by 43.7% and 81.2% vs. 54.2% and 81.2%; OABSS by 48.6% and 78.9% vs. 53.5% and 82.0%; PPIUS by 50.0% and 84.6% vs. 54.2% and 87.5%; Qmax by 42.3% and 74.2% vs. 25.8% and 37.1%; Qave by 31.0% and 50.0% vs. 20.5% and 28.8%; the volume of urination increased by 3.4% and 10.0% versus 5.0% and 3.5%; the volume of residual urine increased by 50.9% and 76.8% versus 47.9% and 74.2%. At the same time, after 3 months of treatment, 36.3% of men in PG1 and 51.9% in PG2 demonstrated the normal shape of UFM curve. After one and three months in PG1 and PG2: the total IPSS score decreased for > 25% in 87.2% and 90.6% versus 98.0% and 100.0%; Qmax increased for > 30% in 55.9% and 15.1% versus 92.2% and 50.0%, due to a different «starting base» and achievement of normal Qmax values in PG2 after only one month of treatment. The combined treatment has demonstrated a high safety level.
Conclusion. The study showed high efficacy and safety of alfuzosin and solifenacin combination therapy in patients with LUTS/BPH and OAB with moderate to severe urinary disorders according to UFM. The success of the treatment was achieved due to the use of an effective combination of drugs and the correct selection of patients for treatment with the exclusion of mechanical BOO cases from the program.
