(076) Effects of Long-term Testosterone Therapy on Erectile Function, Sexual Activity, and Quality of Life in Hypogonadal Men with Type 2 Diabetes – Results from a Registry Study
Authors: Haider A , Haider K S , Doros G , Traish A , Saad F 
Published: May 2023

Abstract

Introduction
Treatment of erectile function (EF) in men with type 2 diabetes (T2DM) remains challenging. EF and sexual activity contribute to quality of life (QoL) in aging men.

Objective
to investigate effects of long-term TTh up to 13 years in men with hypogonadism and T2DM 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, 370 men had type 2 diabetes. 190 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 180 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 9.0±3.4 (9), CTRL 9.7±3.2 (11) years, total observation time: T-group 1703, CTRL 1747 patient-years. Baseline age was 60.0±6.4 (T-group) and 63.0±4.9 years (CTRL) (p&lt;0.0001). 71 patients (37.4%) in the T-group and 74 (41.1%) in CTRL had a history of cardiovascular disease (myocardial infarction MI, stroke, or coronary artery disease diagnosis) (p&lt;0.05). Baseline smoking prevalence was 41.6% (79 men) in the T-group and 37.4% (67 men) in CTRL (p=0.415). At baseline, PDE5-Inhibitors were used by 29.5% (T-group) and 35.0% (CTRL) (p=0.255). T-group: IIEF-EF increased from 15.8±6.0 (means ± SD) at baseline to 29.5±0.9 after 13 years. Changes: IIEF-EF increased by 12.1±0.3 (least squares means ± standard errors) in year 13, p&lt;0.0001 vs. baseline. CTRL: IIEF-EF decreased from 19.2±3.8 at baseline to 6.9±1.0 after 13 years. Changes: IIEF-EF declined by 14.7±0.3 after 13 years. T-group: sex frequency increased from 3.4±1.3 (means ± SD) at baseline to 12.0±5.4 after 13 years. Changes: sex frequency increased by 6.6±0.5 (least squares means ± standard errors) in year 13, p&lt;0.0001 vs. baseline. CTRL: sex frequency decreased from 7.7±3.4 at baseline to 0.0±0.2. Changes: sex frequency declined by 10.5±0.5 (p&lt;0.0001). T-group: AMS decreased from 55.3±9.3 (means ± SD) at baseline to 17.1±0.2 after 13 years. Changes: AMS decreased by 31.4±0.7 (least squares means ± standard errors) in year 13, p&lt;0.0001 vs. baseline. CTRL: AMS increased from 40.1±5.7 at baseline to 65.8±4.6 after 13 years. Changes: AMS increased by 25.8±0.7.

Conclusions
Long-term TTh in men with type 2 diabetes improved erectile function, sexual activity, and QoL despite advancing age. In the untreated control group, sexual function and QoL 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