To evaluate urinary nerve growth factor / creatinine levels from men with symptomatic lower urinary tract symptoms (LUTS) and measure the effect of combination therapy with solifenacin and tamsulosin.
Materials and Methods
From January 2012 – February 2014, all male patients referred for evaluation and management of LUTS were screened for enrollment. In all subjects, urinary NGF and creatinine (Cr) levels were measured and normalized to the urinary Cr concentrations (NGF/Cr). Uroflow, post-void residual, and symptom questionnaires were measured at baseline, 4 weeks, 8 weeks, and 12 weeks after starting combination therapy with solifenacin 5 mg and tamsulosin 0.4 mg. The primary endpoint was urinary NGF and NGF/Cr change from baseline compared to week 12.
10 patients were recruited into the study. Peak urine flow at baseline 20.3 +/- 2.5 ml/sec and post-void residual 45.3 +/- 13.6 ml did not significantly change with 3 months of combination treatment 14.9 +/- 1.8 ml/sec and 58.5 +/- 23.9 ml. However, urine NGF/Cr (pg/mg) levels were significantly reduced following treatment with levels of 39.7 +/- 6.6 at baseline to 17.9 +/- 5.1 at 3 months (p value < 0.05).The decrease in urine NGF/Cr levels correlated with significant decreases in patient reported outcomes.
Male patients with LUTS had decreased urinary NGF/Cr levels after treatment with combination solifenacin and tamsulosin in this novel pilot study. This corresponded with improvement in patient reported outcomes.