(130) SYMPTOMATIC RESPONSE TO LONG-TERM TESTOSTERONE THERAPY IN MEN WITH FUNCTIONAL HYPOGONADISM – NEW RESULTS FROM A REGISTRY STUDY

Abstract Introduction Sexual function, urinary function, and quality of life (QoL) are closely associated. Objective By use of questionnaires, we investigated sexual function, urinary function, and QoL in men with functional hypogonadism in comparison to an untreated control group. Methods In a long-term registry study in men with hypogonadism (defined by total testosterone ≤350 ng/mL and at least moderate symptoms assessed by the Aging Males’ Symptoms scale, AMS) in a single urology office, 824 men had functional hypogonadism. 409 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 415 opted against TTh and served as controls (CTRL). Sexual function by use of IIEF-EF (5 + 1 questions, maximum score: 30), self-reported sexual frequency per month, urinary function by use of the International Prostate Symptom Score (IPSS), and QoL by use of the AMS were assessed at each visit. Means and standard deviations of absolute measures over 16 years of treatment and changes over time between groups, compared by mixed effects model for repeated measures with random effect for intercept and fixed effects for time, group and their interaction, and adjusted for age, weight, WC, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the two groups are reported. Results Mean (median) follow-up: T-group 11.87 ± 3.65 (12), CTRL 11.87 ± 3.52 (13) years, total observation time: T-group 4854, CTRL-total 4928 years. Baseline age was 57.7 ± 7.0 (T-group) and 62.7 ± 5.3 years (CTRL) (p < 0.0001). At baseline, PDE5-Inhibitors were used by 28.9% (T-group) and 21.7% (CTRL) (p < 0.05). Prevalence of ED at baseline was 92.9% in the T-group and 99.0% in CTRL. According to IIEF-EF (5 + 1), in the T-group, 23% had mild, 23.5% mild-to-moderate, 32.3% moderate, and 14.2% severe ED. In CTRL, 35.2% had mild, 46% mild-to-moderate, 15.7% moderate, and 2.2% severe ED. Erectile function: In the T-group, IIEF-EF increased/improved from 17.0 ± 5.9 to 29.4 ± 0.7 in year 16. In CTRL, IIEF-EF decreased/worsened from 19.6 ± 3.7 to 6.7 ± 0.9. The estimated adjusted difference between groups at 16 years was 26.3 (95% CI: 25.3;27.2) (p < 0.0001 for all). Sex frequency: In the T-group, self-reported sex frequency per month (SF/M) increased from 3.6 ± 1.3 to 10.2 ± 2.0 in year 16. In CTRL, SF/M decreased from 8.2 ± 3.2 to 0 ± 0. The estimated adjusted difference between groups was 14.5 (95% CI: 13.2;15.8) (p < 0.0001 for all). IPSS: In the T-group, IPSS decreased/improved from 7.0 ± 3.5 to 1.5 ± 2.0 in year 16. In CTRL, IPSS increased/worsened from 4.9 ± 2.0 to 14.3 ± 5.3. The estimated adjusted difference between groups was -14.4 (95% CI: -15.3;-13.6) (p < 0.0001 for all). QoL: In the T-group, AMS decreased/improved from 53.8 ± 9.8 to 17.6 ± 0.5 in year 16. In CTRL, AMS increased/worsened from 40.7 ± 5.8 to 67.4 ± 6.2. The estimated adjusted difference between groups was -55.6 (95% CI: -57.4;-53.8) (p < 0.0001 for all). Conclusions Long-term testosterone therapy in men with functional hypogonadism improved symptoms of sexual function, urinary function, and quality of life. In the untreated control group, sexual function, urinary function, and quality of life deteriorated. Disclosure Yes, this is sponsored by industry/sponsor: Gruenenthal GmbH, Aachen, Germany. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Gruenenthal GmbH, Aachen, Germany.