(071) Effects of Long-term Testosterone Therapy on Erectile Function, Sexual Activity, and Quality of Life in Men with Functional Hypogonadism – results from a registry study

Abstract

Abstract Introduction Erectile function (EF) and sexual activity contribute to quality of life (QoL) in aging men. Testosterone therapy (TTh) has well-established beneficial effects on EF and QoL while there is less information on sexual activity. Objective to investigate effects of long-term TTh up to 13 years in men with functional hypogonadism compared to an untreated control group. Methods In an ongoing registry study in men with hypogonadism (total testosterone ≤350 ng/mL and at least moderate symptoms on the Aging Males’ Symptoms scale, AMS) in a single urology office, men with primary hypogonadism were excluded from the analysis. 797 men had functional hypogonadism. 394 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 403 opted against TTh and served as controls (CTRL). IIEF-EF (5+1 questions, maximum score: 30) and AMS were assessed at each visit. Patients were asked at each visit about sexual activity per month. Absolute measures with standard deviations (SDs) as well as changes over time, adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between groups, are reported for a duration of 13 years. Results Mean (median) follow-up: T-group 10.1±3.1 (11), CTRL 10.5±3.0 (12) years, total observation time: T-group 3975, CTRL 4220 patient-years. Baseline age was 58.1±6.6 (T-group) and 63.2±4.8 years (CTRL) (p<0.0001). At baseline, PDE5-Inhibitors were used by 27.2% (T-group) and 22.1% (CTRL) (p=0.096). T-group: IIEF-EF increased from 17.2±5.8 (means ± SD) at baseline to 29.4±1.0 after 13 years. Changes: IIEF-EF increased by 11.0±0.2 (least squares means ± standard errors) in year 13, p<0.0001 vs. baseline. For the entire observation time, the year-to-year changes were always statistically significant vs. previous year. CTRL: IIEF-EF decreased from 19.8±3.4 at baseline to 7.1±1.1 after 13 years. Changes: IIEF-EF declined by 13.9±0.2 after 13 years. For the entire observation time, year-to-year changes were always statistically significant vs. previous year. T-group: sex frequency increased from 3.6±1.4 (means ± SD) at baseline to 11.0±4.3 after 13 years. Changes: sex frequency increased by 6.2±0.3 (least squares means ± standard errors) in year 13, p<0.0001 vs. baseline. For the first four years, year-to-year changes were statistically significant vs. previous year. CTRL: sex frequency decreased from 8.4±3.1 at baseline to 0.0±0.3. Changes: sex frequency declined by 10.3±0.3 (p<0.0001). For the first ten years, year-to-year changes were always statistically significant vs. previous year. T-group: AMS decreased from 53.3±9.6 (means ± SD) at baseline to 17.0±0.1 after 13 years. Changes: AMS decreased by 29.9±0.4 (least squares means ± standard errors) in year 13, p<0.0001 vs. baseline. For the first four years, the year-to-year changes were statistically significant vs. previous year. CTRL: AMS increased from 40.4±5.6 at baseline to 65.8±4.3 after 13 years. Changes: AMS increased by 23.6±0.4. For the entire observation time, the year-to-year changes were statistically significant vs. previous year. Conclusions Long-term TTh in men with functional hypogonadism improved erectile function, sexual activity, and QoL despite advancing age. In the untreated control group, these parameters deteriorated progressively. Disclosure Yes, this is sponsored by industry/sponsor: Bayer AG, Berlin, 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: Bayer AG, Berlin, Germany