Login to Access Video or Poster Abstract: MP46-03
Sources of Funding: Bayer Pharma AG partially funded data entry and statistical analyses.

Introduction

Long-term data on effects of testosterone therapy (TTh) on urinary function in hypogonadal men published so far are from observational studies without a control group. We present registry data including an untreated hypogonadal control group.

Methods

Registry study in 656 men with testosterone ≤350 ng/dL and hypogonadal symptoms. 360 received TU 1000 mg/12 weeks following an initial 6-week interval (T-group). 296 men opted against TTh and served as controls (CTRL). 8-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. Changes were adjusted for age, weight, waist circumference, blood pressure, fasting glucose, lipids and quality of life to account for baseline differences between groups. In order to further validate results, propensity matching was performed for baseline age, BMI, and waist circumference. 82 men in each group fulfilled criteria.

Results

Total group: mean age was 57.4±7.3 years in the T-group and 64.8±4.3 in CTRL, median follow-up time 7 years for both._x000D_ In the T-group, IPSS decreased from 6.4±4.0 to 2.1±1.0 with a change from baseline of 5.0 points. In CTRL, IPSS increased from 4.5±2.0 to 6.5±2.6 after 8 years by 1.8 points (p<0.0001 for both). Residual urine volume decreased from 47.3±22.8 to 13.7±4.6 mL in the T-group and increased from 48.3±16.3 to 64.5±22.2 in CTRL. Prostate volume increased from 29.2±10.4 to 31.1±11.5 mL in the T-group (p<0.0001) and fell from 34.5±5.9 to 33.5±12.0 in CTRL (NS)._x000D_ _x000D_ Propensity-matched group: mean age was 61.7±5.1 years in the T-group and 61.6±2.9 in CTRL, median follow-up time 8 years in the T-group and 7 in CTRL._x000D_ In the T-group, IPSS decreased from 7.4±4.2 to 2.0±0.9 with a change from baseline of 5.4 points. In CTRL, IPSS increased from 4.3±2.3 to 7.0±2.6 after 8 years by 1.9 points (p<0.0001 for both). Residual urine volume decreased from 50.6±23.6 to 14.0±4.7 mL in the T-group and increased from 45.7±16.4 to 64.6±16.7 in CTRL. Prostate volume increased from 31.4±12.0 to 33.2±12.7 mL in the T-group (p<0.0001) and from 33.4±6.2 to 33.6±11.0 in CTRL (NS)._x000D_

Conclusions

Urinary function is improved and preserved for a prolonged period of time by TTh in hypogonadal men and deteriorates in untreated hypogonadal men. The observed changes seem independent of prostate volume.

Funding

Bayer Pharma AG partially funded data entry and statistical analyses.