Introduction: Lower urinary tract symptoms (LUTS) in elderly men are closely associated with quality of life (QoL). We investigated long-term effects of testosterone therapy (TTh) in hypogonadal men with type 2 diabetes (T2DM) in a registry study.
Methods: Of 361 hypogonadal men with T2DM, 183 men chose TTh by means of testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 178 men opted against TTh and served as controls (CTRL). 12-year data are presented. Changes over time between groups were compared by a mixed effects model for repeated measures with a random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups.
Results: Mean age at baseline: 60.7±5.5 years (T-group) and 63.0±4.9 (CTRL) (p < 0.0001). Mean (median) follow-up: T-group 8.2±3.2 (8), CTRL 9.2±2.8 (10) years. Alpha-blockers were used at baseline by 60.1% in the T-group and 57.3% in CTRL (p=0.5326), PDE5 inhibitors by 27.3% in the T-group and 34.3% in CTRL (p=0.1527).
IPSS (baseline: 8.2±3.2) decreased by 6.0±0.3 (p < 0.0001) in the T-group in year 12. In CTRL, IPSS (baseline: 5.1±1.8) increased by 4.3±0.3 (p < 0.0001). Estimated adjusted difference between groups: -10.3 [95% CI: -11.1;-9.4] (p < 0.0001).
Residual bladder volume (RBV) in the T-group (baseline: 65.8±22.4) decreased by 52.3±2.7 mL (p < 0.0001) in year 12. In CTRL, RBV (baseline: 53.6±15.5) increased by 42.3±2.7 mL (p < 0.0001). Estimated adjusted difference between groups: -94.6 mL [95% CI: -102.9;-86.3] (p < 0.0001).
QoL, assessed by the Aging Males’ Symptoms scale (AMS), improved from 54.9±9.2 (severe symptoms) by 31.0 points in the T-group to 15.7 (no symptoms) and worsened from 40.0±5.7 (moderate symptoms) by 23.9 points to 70.5 (severe symptoms) in CTRL.Adherence to TTh was 100% as all injections were administered in the office and documented. No patient dropped out.
Conclusions: In hypogonadal men with T2DM, long-term TTh improves LUTS sustainably over 12 years. This may have contributed to improvements in QoL. In the untreated control group, both LUTS and QoL deteriorated.
Source of Funding: Data entry and statistical analysis was compensated by Bayer AG.
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