Introduction: Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in elderly men are closely associated with quality of life (QoL). We aimed to assess long-term effects of testosterone therapy (TTh) in hypogonadal men in a registry study. Methods: 898 men with hypogonadism, 481 men chose TTh by means of testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 417 men opted against TTh and served as controls (CTRL). 14-year data are presented. Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the groups. Means and standard deviations of absolute measures over 14 years are reported. Results: Baseline age was 56.5±8.0 years in the T-group and 62.7±5.3 years in CTRL (p < 0.0001). Mean follow-up was 11.0±3.2 years in the T-group and 11.1±3.3 in CTRL. Median follow-up was 12 years in the T-group and 12 years in CTRL. At baseline, alpha-blockers were used by 36.6% (T-group) and 50.2% (CTRL) (p < 0.0001), 5a-reductase inhibitors by 2.1% and 8.6% (p < 0.0001), and PDE5-Inhibitors by 26.4% and 22.1% (p=0.1308). IPSS (baseline: 6.4±3.7) decreased to 1.5±0.7 (p < 0.0001) in the T-group in year 14. In CTRL, IPSS (baseline: 4.9±1.9) increased to 11.4±5.1 (p < 0.0001). Estimated adjusted difference between groups: -11.0 (p < 0.0001). Residual bladder volume (RBV) in the T-group (baseline: 50.7±25.9) decreased by 39.3±1.4 mL (p < 0.0001) in year 14. In CTRL, RBV (baseline: 51.7±16.7) increased by 58.8±1.5 mL (p < 0.0001). Estimated adjusted difference between groups: -94.4 mL [95% CI: -98.2;-90.7] (p < 0.0001). IIEF-EF in the T-group increased from 17.3±5.9 (mild to moderate) by 11.1±0.2 to 29.5±0.9 (no ED) in year 14. In CTRL, IIEF-EF decreased from 19.7±3.5 (mild to moderate) by 14.5±0.2 to 6.8±0.9 (severe). Estimated adjusted difference between groups: 23.5 (95% CI: 23.0;24.1) (p < 0.0001). QoL, assessed by the Aging Males’ Symptoms scale (AMS), improved from 53.0±9.8 (severe symptoms) by 29.8 points in the T-group to 17.2 (no symptoms) and worsened from 40.4±5.6 (moderate symptoms) by 24.7 points to 66.7 (severe symptoms) in CTRL. Conclusions: In men with functional hypogonadism, long-term TTh improves LUTS and ED sustainably over 14 years. This may have contributed to improvements in QoL. In the untreated control group, LUTS, ED, and QoL deteriorated. SOURCE OF Funding: Data entry was compensated by Bayer AG.
