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F. Saad, G. Doros, A. Haider, K. Haider, A. Traish, HP-03-002 Erectile Function in 164 Propensity-Matched Hypogonadal Men from A Registry with or without Treatment with Testosterone Undecanoate Injections (TU) for up to 8 Years, The Journal of Sexual Medicine, Volume 14, Issue Supplement_4a, April 2017, Page e147, https://doi.org/10.1016/j.jsxm.2017.03.036
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Objective
Randomised, placebo-controlled trials over several years cannot be conducted in hypogonadal men for ethical reasons. In a long-term registry, we performed propensity matching to identify two groups with similar baseline characteristics.
Methods
Registry study in 656 men with testosterone ≤12.1 nmol/L and hypogonadal symptoms. All patients with classical hypogonadism were treated with testosterone. The others were given the choice for or against treatment. This resulted in differences in baseline characteristics, in particular, age. In order to overcome these differences between groups, propensity matching was performed for baseline age and BMI. 164 patients were identified of whom 82 received testosterone (T-group) and 82 served as untreated controls (CTRL). Testosterone treatment consisted in 3-monthly injections of TU.
Results
Mean age was 61.6±4.2 years, median follow-up time 7 years. T-levels rose in the T-group from 9.6±1.4 nmol/L to 16.6±1.9 nmol/L (p<0.0001) and dropped in CTRL from 9.6±1.1 to 8.8±1.6 nmol/L (p<0.05). In the T-group, IIEF-EF (maximum score: 30) increased from 19.5±5.6 to 25.8±3.9 with a change from baseline by 5.9 points. The improvement was statistically significant for the first 3 years, remained statistically significant vs baseline for 8 years and stable compared to previous years. In CTRL, IIEF-EF decreased from 20.2±3.3 to 12.4±1.0 after 8 years by 8.6 points (p<0.0001 until year 7). The estimated adjusted difference between groups was 13.8 points after 8 years of observation (p<0.0001). Adherence to testosterone was 100% as all injections were administered in the office and documented. No patient dropped out. There were no major adverse cardiovascular events in the T-group. In CTRL, there were 8 MIs (10%), 8 strokes (10%), and 5 deaths (6%).
