Testosterone Undecanoate Injections Research Articles

Effect of testosterone formulations on hematocrit in transgender individuals: A systematic review.

Approximately, 11% of trans men experience erythrocytosis diagnosis due to testosterone administration during the first year of the gender-affirming hormone treatment (GAHT). To identify and compare the effect of different testosterone formulations on hematocrit (Hct) and diagnose erythrocytosis in trans men. This systematic review was based on PRISMA guidelines. We performed an electronic search of PubMed, Embase, and Web of Science in January 2024. The Newcastle-Ottawa scale was used to evaluate the quality of evidence in the observational studies. Of the 152 records retrieved, 18 met the eligibility criteria. Studies observed an increase of up to 5% in Hct in trans men using injectable testosterone undecanoate (TU), and up to 6.9% in trans men using intermediate injectable testosterone esters (TE). Trans men using TE experience a larger increase in serum Hct levels compared to those receiving TU. Erythrocytosis prevalence varies according to the cutoff used (50%, 52%, and 54%). Erythrocytosis was also associated with tobacco use, age at initiation of hormone therapy, body mass index (BMI), and pulmonary conditions. Studies that evaluated the effect of testosterone formulation on erythrocytosis diagnosis present conflicting result. Trans men have a hazard ratio of 7.4 (95% CI: 4.1, 13.4) of developing erythrocytosis compared to cisgender men, using a 52% hematocrit cutoff. All testosterone formulations result in an increase in Hct, irrespective of dose, formulation, and administration method. Smoking, higher age at initiation of the testosterone therapy, higher BMI, and a predisposing medical history are associated with this increase in Hct. The difference in effect of TE and TU on Hct is conflicting, although it is important to point out that these data come from observational studies, retrospective, and with a small-sample size.

Recent Developments in Promising Hormonal and Non- Hormonal Male Contraceptives: A Review

New male contraceptive methods would expand male and female contraceptive alternatives and enhance male contraceptive agency. Since 1969, a program for developing contraceptives has been financed by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which also continues to fund the majority of hormonal male contraceptive development today. Also, the early stages of non-hormonal techniques start to develop. The hormonal male contraceptive methods, include testosterone undecanoate injection plus norethisterone enanthate injection, implants of testosterone plus depo-medroxyprogesterone acetate injection, testosterone enanthate injection, and other testosterone-based methods. The non-hormonal methods, include novel hormone-free substances such as retinoic acid inhibitors, sperm ion channel blockers, and vasal peristalsis blockers. The review provides insights into the efficacy, safety, and potential side effects of each method, and highlights the current state of research and development in the field of male contraception.

Testosterone Treatment, Weight Loss, and Health-related Quality of Life and Psychosocial Function in Men: A 2-year Randomized Controlled Trial.

To determine the effect of testosterone vs placebo treatment on health-related quality of life (HR-QOL) and psychosocial function in men without pathologic hypogonadism in the context of a lifestyle intervention. Secondary analysis of a 2-year randomized controlled testosterone therapy trial for prevention or reversal of newly diagnosed type 2 diabetes, enrolling men ≥ 50 years at high risk for type 2 diabetes from 6 Australian centers. Injectable testosterone undecanoate or matching placebo on the background of a community-based lifestyle program. Self-reported measures of HR-QOL/psychosocial function. Of 1007 participants randomized into the Testosterone for Type 2 Diabetes Mellitus (T4DM) trial, 648 (64%) had complete data available for all HR-QOL/psychosocial function assessments at baseline and 2 years. Over 24 months, while most measures were not different between treatment arms, testosterone treatment, compared with placebo, improved subjective social status and sense of coherence. Baseline HR-QOL/psychosocial function measures did not predict the effect of testosterone treatment on glycemic outcomes, primary endpoints of T4DM. Irrespective of treatment allocation, larger decreases in body weight were associated with improved mental quality of life, mastery, and subjective social status. Men with better baseline physical function, greater sense of coherence, and fewer depressive symptoms experienced greater associated decreases in body weight, with similar effects on waist circumference. In this diabetes prevention trial, weight loss induced by a lifestyle intervention improved HR-QOL and psychosocial function in more domains than testosterone treatment. The magnitude of weight and waist circumference reduction were predicted by baseline physical function, depressive symptomology, and sense of coherence.

FRI439 Spermatogenesis Induction For Hypogonadotrophic Hypogonadism In An Australian Tertiary Hospital Andrology Service

Abstract Disclosure: S. Sarlos: None. M. Herath: None. I. Sim: None. R. Upreti: None. R.I. McLachlan: None. C.A. Allan: None. Infertility affects 8-12% of couples with male factors contributing to 50% and solely responsible in 20-30% of cases. Male infertility due to hypogonadotrophic hypogonadism (HH) is amenable to medical treatment. We report a series of 23 men treated for infertility from HH (congenital n=13, acquired n=10) with a median age of 33 years. Causes included panhypopituitarism (n=11) [empty sella (n=2), adenoma (n=3), craniopharyngioma (n=1), pituitary hypoplasia (n=3), CHARGE syndrome (n=1), cranial radiotherapy (n=1)], Kallmann syndrome (n=1), thalassaemia major (n=1) and idiopathic (n=10). Urinary or recombinant human chorionic gonadotrophin (hCG) as an LH substitute was used based on established protocols. Commencing doses were 1500 IU or 62.5mcg s/cut twice weekly respectively and titrated to achieve normal serum total testosterone. Recombinant FSH was added after 6 months for persisting azoospermia. Wherever possible, men previously treated with long-acting injectable testosterone undecanoate were transitioned to transdermal testosterone for a minimum of 6 months prior to initiation of gonadotrophin therapy. There was wide variability in time to first appearance of sperm (median 16 months, range 4 - 42). In androgen treatment-naive men with acquired HH in adulthood (n=9), sperm was detected at a median 8 months (range 3 - 21 months) and for 4 men, hCG monotherapy was sufficient. For men with congenital causes of HH (n=13), time to first sperm detection was longer (median 17 months, range 12 - 42) and all required addition of FSH. In men previously treated with intramuscular testosterone (n=8), the median time to sperm appearance was 17 months (range 12-24) as compared to 13 months (5-42) in men treated with transdermal testosterone (n=6). To date, 11 of the 16 men actively seeking fertility have had children, with 7 requiring assisted reproduction. Gonadotrophin therapy is an effective fertility treatment for most men with HH. Clinicians can anticipate a longer time to spermatogenesis in men pre-treated with intramuscular androgens and those with congenital HH. Couples often move to assisted reproductive therapy, likely due to considerations such as semen quality, co-existing female factors and/or desire for prompt conception. Presentation: Friday, June 16, 2023

(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

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<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<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<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<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<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<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

(496) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on the Lipid Pattern – Results from a Registry Study

Abstract Introduction The lipid pattern plays a role in the assessment of cardiometabolic risks such as atherogenicity (non-HDL), arteriosclerotic cardiovascular disease (remnant cholesterol), or insulin resistance (TG:HDL ratio). A recent meta-analysis suggested that, in patients with metabolic disorders, only a reduction of triglycerides achieved statistical significance across controlled and uncontrolled studies (Corona G et al. Exp Rev Clin Pharmacol 2021;14:1091-1103). The lipid pattern plays a role in the assessment of cardiometabolic risks such as atherogenicity (non-HDL), arteriosclerotic cardiovascular disease (remnant cholesterol), or insulin resistance (TG:HDL ratio). A recent meta-analysis suggested that, in patients with metabolic disorders, only a reduction of triglycerides achieved statistical significance across controlled and uncontrolled studies (Corona G et al. Exp Rev Clin Pharmacol 2021;14:1091-1103). Another recent meta-analysis suggested significant reductions of total cholesterol, LDL, HDL and triglycerides (Hudson J et al. Lancet Healthy Longev 2022;3:e381–93). Objective to investigate effects of long-term TTh up to 13 years on the lipid pattern in men with functional hypogonadism and obesity 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, 491 men had functional hypogonadism and obesity (BMI ≥30 kg/m2). 292 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 199 opted against TTh and served as controls (CTRL). Total cholesterol, LDL, HDL, and triglycerides were assessed at each visit. 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 9.4±3.3 (10) years, total observation time: T-group 2944, CTRL 1861 patient-years. Baseline age: 59.5±6.0 (T-group) and 63.0±5.0 years (CTRL) (p<0.0001). Total cholesterol (TC) (mmol/L for all lipids) decreased by 2.9±0.1 (least squares means ± SEs) from 8.2±1.0 to 5.1±0.3 (means ± SDs) in T-group and increased by 1.38±0.1 from 7.3±1.0 to 8.6±1.2 in CTRL (p<0.0001 for all). HDL increased by 0.5±0.0 from 1.0±0.4 to 1.6±0.3 in T-group and decreased by 0.4±0.0 from 1.1±0.5 to 0.8±0.4 in CTRL (p<0.0001 for all). The TC:HDL ratio decreased by 5.4±0.2 from 9.2±3.8 to 3.4±0.6 in T-group and increased by 6.5±0.3 from 8.0±3.8 to 12.6±5.8 in CTRL (p<0.0001 for all). LDL decreased by 1.9±0.0 from 4.5±0.9 to 2.5±0.3 in T-group and increased by 1.2±0.1 from 4.2±1.3 to 5.4±1.3 in CTRL (p<0.0001 for all). Triglycerides (TG) decreased by 1.1±0.0 from 3.4±0.5 to 2.2±0.1 in T-group and increased by 0.7±0.0 from 3.2±0.5 to 3.9±0.5 in CTRL (p<0.0001 for all). Non-HDL decreased by 3.4±0.1 from 7.2±1.0 to 3.5±0.2 in T-group and increased by 1.6±0.1 from 6.2±1.1 to 7.8±1.3 in CTRL (p<0.0001 for both). Remnant cholesterol decreased by 1.5±0.1 from 2.7±0.9 to 1.0±0.3 in T-group and increased by 0.5±0.1 from 2.1±1.0 to 2.4±0.7 in CTRL (p<0.0001 for both). The TG:HDL ratio decreased by 5.0±0.2 from 8.7±3.9 to 3.2±0.6 in T-group and increased by 6.8±0.3 from 8.1±3.9 to 13.6±6.7 in CTRL (p<0.0001 for both). Conclusions Long-term TTh in men with functional hypogonadism and obesity improved all components of the lipid pattern. In the untreated control group, the lipid pattern deteriorated. 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.

(397) Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity Improves Surrogate Parameters of Liver Function in a Urological Registry Study

Abstract Introduction Hepatic steatosis is highly prevalent in patients with hypogonadism and obesity. Fatty liver is increasingly recognized as cardiovascular risk factor. The gold standard assessment – histological evaluation of liver biopsies – cannot be performed in routine clinical practice. However, the fatty liver index (FLI) can be calculated using the formula by Bedogni: FLI = (e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745) / (1 + e 0.953*loge (triglycerides) + 0.139*BMI + 0.718*loge (ggt) + 0.053*waist circumference - 15.745) * 100 (Bedogni G et al. BMC Gastroenterol 2006;6:33). A FLI <30 rules out and a FLI ≥60 rules in fatty liver. Objective to investigate effects of long-term testosterone therapy (TTh) up to 13 years on surrogate parameters of liver function in men with functional hypogonadism and obesity in comparison 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, 491 men had functional hypogonadism and obesity (BMI ≥30 kg/m2). 292 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 199 opted against TTh and served as controls (CTRL). Height was measured at baseline, weight, waist circumference, triglycerides and γ-GT were assessed at each visit and the fatty liver index (FLI) calculated. AST, ALT, and bilirubin were also measured at each visit. Mean absolute measures with standard deviations (SDs) are reported for a duration of 13 years. Results Mean (median) follow-up: T-group 10.1±3.1 (11), CTRL 9.4±3.3 (10) years. Baseline age was 59.5±6.0 (T-group) and 63.0±5.0 years (CTRL) (p<0.0001). Triglycerides decreased from 3.4±0.5 to 2.2±0.1 in the T-group and increased from 3.2±0.5 to 3.9±0.5 in CTRL (p<0.0001 for both). γ-GT (U/L) decreased from 42.9±22.8 to 20.5±6.4 in the T-group and increased from 35.5±11.6 to 61.7±5.9 in CTRL (p<0.0001 for both). AST (U/L) decreased from 38.4±13.3 to 20.8±1.9 in the T-group and increased from 28.6±9.0 to 54.1±11.9 in CTRL (p<0.0001 for both). ALT (U/L) decreased from 41.4±13.7 to 24.7±2.1 in the T-group and increased from 32.7±9.4 to 60.2±13.8 in CTRL (p<0.0001 for both). Bilirubin decreased from 0.53±0.27 to 0.18±0.05 mg/dL in the T-group and increased from 0.44±0.23 to 1.09±0.27 mg/dL in CTRL (p<0.0001 for both). Waist circumference from 115.0±13.2 to 97.5±4.6 cm in the T-group and increased from 118.6±11.4 to 121.2±6.1 cm in CTRL (p<0.0001 for all). BMI decreased from 36.8±3.6 to 28.3±2.1 kg/m2 in the T-group and increased from 33.9±3.3 to 34.9±2.2 kg/m2 in CTRL (p<0.0001 for all). FLI decreased from 95.1±4.6 to 61.3±11.2 in the T-group and increased from 94.1±4.4 to 98.0±1.3 in CTRL (p<0.0001 for both). Conclusions Long-term testosterone therapy in men with functional hypogonadism and obesity improved surrogate parameters of liver function indicating an improvement in hepatic steatosis. All measures deteriorated over time in untreated obese hypogonadal control patients. 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.

(396) Effects of Long-term Testosterone Therapy in Men with Functional Hypogonadism and Obesity on Weight, Waist Circumference, and Erectile Function – Results from a Registry Study

Abstract Introduction Obesity is a risk factor for erectile dysfunction (ED). Long-term testosterone therapy (TTh) has been shown to improve anthropometric parameters as well as erectile function. Objective to investigate effects of long-term TTh up to 13 years in men with functional hypogonadism and obesity 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, 491 men had functional hypogonadism and obesity (BMI ≥30 kg/m2). 292 men received testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group), 199 opted against TTh and served as controls (CTRL). Weight, waist circumference, and IIEF-EF (5+1 questions, maximum score: 30) were assessed at each visit. 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 9.4±3.3 (10) years, total observation time: T-group 2944, CTRL 1861 patient-years. Baseline age was 59.5±6.0 (T-group) and 63.0±5.0 years (CTRL) (p<0.0001). In the T-group, 35.3%, 44.9% and 19.9% had obesity class I (BMI 30.0-34.4), II (BMI 35.0-39.9) and III (BMI ≥40 kg/m2), respectively. In CTRL, 71.9%, 22.1%, and 6%, had obesity class I, II, and III, respectively. At baseline, PDE5-Inhibitors were used by 25.0% (T-group) and 25.6% (CTRL) (p=0.875). T-group: weight (kg) decreased by 23.9±0.4 (least squares means ± standard errors) from 114.5±11.8 to 87.5±6.7 (means ± standard deviations) after 13 years. CTRL: weight increased by 8.4±0.6 from 105.6±10.5 to 107.9±6.2 (p<0.0001 for all). T-group: waist circumference (cm) decreased by 13.8±0.3 (least squares means ± SEs) from 115.0±13.2 to 97.5±4.6 (means ± SDs) after 13 years CTRL: waist circumference increased by 9.3±0.4 from 118.6±11.4 to 121.2±6.1 (p<0.0001 for all). T-group: BMI (kg/m2) decreased by 7.7±0.1 (least squares means ± SEs) from 36.8±3.6 to 28.3±2.1 after 13 years CTRL: BMI increased by 2.7±0.2 from 33.9±3.3 to 34.9±2.2 (p<0.0001 for all). Per cent weight loss from baseline was 22.8±4.9% in the T-group, per cent weight gain was 8.4±3.7% in CTRL (p<0.0001 for both). In the T-group, 118 patients (40.4%) achieved weight loss of ≥20% after a mean observation time of 92 months (minimum: 27, maximum: 189). No patient in CTRL achieved weight loss of ≥20%. 290 men (99.3%) in the T-group vs. 8 men (4.0%) in CTRL achieved weight loss of ≥5%. T-group: IIEF-EF increased by 11.4±0.3 (least squares means ± SEs) from 17.2±5.9 (means ± SD) at baseline to 29.4±1.0 after 13 years. CTRL: IIEF-EF decreased by 15.1±0.4 from 19.0±3.9 at baseline to 7.0±1.0 after 13 years (p<0.0001 for all). Conclusions Long-term TTh in men with functional hypogonadism and obesity improved weight, waist circumference and erectile function. In the untreated control group, anthropometric measures and erectile function deteriorated. 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

(398) Remission of Type 2 Diabetes, Mortality, and Major Adverse Cardiovascular Events in Men with Hypogonadism and Type 2 Diabetes Receiving Long-term Testosterone Therapy in Comparison to an Untreated Control Group in a Urological Registry Study

Abstract Introduction We had reported previously that 34.3% of patients with hypogonadism and type 2 diabetes (T2DM) receiving testosterone therapy (TTh) up to 11 years in our registry study achieved remission of their T2DM after a mean time of 8.6±2.9 years (Haider KS et al. Diabet Obes Metab 2020;22:2055-2068). Remission is defined as discontinuation of anti-diabetic medication while maintaining HbA1c within the non-diabetic range for at least three months. Objective to investigate effects of long-term TTh up to 13 years in men with hypogonadism and T2DM on glycemic control, remission of T2DM, mortality, and major adverse cardiovascular events (MACE). 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). Patients’ T2DM was treated at the local diabetes center which included mandatory lifestyle education. Glycemic control (HbA1c) was measured and insulin resistance (HOMA-IR) calculated at each or each other visit. 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<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<0.05). Baseline smoking prevalence was 41.6% (79 men) in the T-group and 37.4% (67 men) in CTRL (p=0.415). HbA1c decreased from 9.5±1.4% to 5.5±1.2% in the T-group and increased from 7.8±0.7% to 10.5±1.2% in CTRL (means ± SDs). Mean adjusted change from baseline (least squares means ± SEs) at 13 years was -3.7±0.2 (T-group) and +3.4±1.2 (CTRL) (p<0.0001 for all). HOMA-IR decreased from 10.2±2.1 to 1.5±0.3 in the T-group and increased from 7.3±1.3 to 14.8±2.5 in CTRL. Mean adjusted change from baseline at 13 years was -8.3±0.3 (T-group) and +6.8±0.4 (CTRL) (p<0.0001 for all). In the T-group, 108 patients (56.8%) went into remission. The median time to remission was 87 months. During the entire observation period, 21 patients (11.1%) died in the T-group vs. 62 (34.4%) in CTRL (p<0.0001). Major adverse cardiovascular events (MACE): in the T-group, there were no cases of MI or stroke. In CTRL, there were 62 cases of MI (34.4%) and 51 cases of stroke (28.3%). Conclusions Long-term TTh in men with hypogonadism and T2DM improves glycemic control and insulin resistance and reduces mortality and MACE, compared to untreated controls. Every other patient receiving TTh achieves remission of T2DM. 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.

(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 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

MP79-09 LONG-TERM TESTOSTERONE THERAPY IN MEN WITH FUNCTIONAL HYPOGONADISM IMPROVES KIDNEY FUNCTION

You have accessJournal of UrologyCME1 Apr 2023MP79-09 LONG-TERM TESTOSTERONE THERAPY IN MEN WITH FUNCTIONAL HYPOGONADISM IMPROVES KIDNEY FUNCTION Ahmad Haider, Karim Sultan Haider, Gheorghe Doros, and Abdulmaged Traish Ahmad HaiderAhmad Haider More articles by this author , Karim Sultan HaiderKarim Sultan Haider More articles by this author , Gheorghe DorosGheorghe Doros More articles by this author , and Abdulmaged TraishAbdulmaged Traish More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003356.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Testosterone deficiency is a prevalent condition in men with chronic kidney disease. We investigated effects of testosterone therapy on renal parameters and renal function in men with functional hypogonadism. METHODS: 898 men with hypogonadism, 481 men chose TTh by means of testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 417 men opted against TTh and served as controls (CTRL). 14-year data are presented.Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the groups.Means and standard deviations of absolute measures over 14 years are reported.eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula. RESULTS: Baseline age was 56.5±8.0 years in the T-group and 62.7±5.3 years in CTRL (p<0.0001). Mean follow-up was 11.0±3.2 years in the T-group and 11.1±3.3 in CTRL. Median follow-up was 12 years in the T-group and 12 years in CTRL.Creatinine (mg/dL) decreased by 0.10±0.03 at 14 years in the T-group (p<0.005) and increased by 0.33±0.04 in CTRL (p<0.0001). Estimated adjusted difference between groups at 14 years was -0.50 [95% CI: -0.58;-0.41] (p<0.0001). γGT (U/L) decreased by 24.0±0.7 at 14 years in the T-group and increased by 26.2±0.8 in CTRL, estimated adjusted difference between groups at 14 years: -47.3 [95% CI: -49.4;-45.1] (p<0.0001 for all). eGFR-(MDRD) (mL/min/1.73 m2) increased by 10.3±0.7 in T-group, reaching a peak in year 8 with a small but steady decline thereafter. eGFR-MDRD decreased progressively by 27.3±0.8 in CTRL. Estimated adjusted difference between groups at year 14: 41.5 [95% CI: 39.5;43.6] (p<0.0001 for all). Systolic blood pressure (mmHg) decreased in the T-group by 23.5±0.7 and increased in CTRL by 21.6±0.8. Estimated adjusted difference between groups: -38.1 [95% CI: -40.2;-35.9] (p<0.0001 for all). Diastolic blood pressure (mmHg) decreased by 14.7±0.5 (T-group) and increased by 14.3±0.5 (CTRL). Estimated adjusted difference between groups: -25.0 [95% CI: -26.5;-23.6] (p<0.0001 for all). During the entire observation period, 49 deaths (10,2%) occurred in the T-group. In CTRL, 133 deaths (31.9%) were recorded. All injections were administered in the office and documented. CONCLUSIONS: Long-term testosterone therapy in men with hypogonadism improves renal function demonstrated by eGFR, potentially contributing to reduced mortality. Source of Funding: Data entry was compensated by Bayer AG © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1144 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ahmad Haider More articles by this author Karim Sultan Haider More articles by this author Gheorghe Doros More articles by this author Abdulmaged Traish More articles by this author Expand All Advertisement PDF downloadLoading ...

PD23-09 LUTS, ED, AND QOL IMPROVE UNDER LONG-TERM TESTOSTERONE THERAPY IN OBESE MEN WITH FUNCTIONAL HYPOGONADISM

You have accessJournal of UrologyCME1 Apr 2023PD23-09 LUTS, ED, AND QOL IMPROVE UNDER LONG-TERM TESTOSTERONE THERAPY IN OBESE MEN WITH FUNCTIONAL HYPOGONADISM Ahmad Haider, Karim Sultan Haider, Gheorghe Doros, and Abdulmaged Traish Ahmad HaiderAhmad Haider More articles by this author , Karim Sultan HaiderKarim Sultan Haider More articles by this author , Gheorghe DorosGheorghe Doros More articles by this author , and Abdulmaged TraishAbdulmaged Traish More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003296.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in elderly men are closely associated with quality of life (QoL). We aimed to assess long-term effects of testosterone therapy (TTh) in hypogonadal men in a registry study. METHODS: 898 men with hypogonadism, 481 men chose TTh by means of testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 417 men opted against TTh and served as controls (CTRL). 14-year data are presented. Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the groups. Means and standard deviations of absolute measures over 14 years are reported. RESULTS: Baseline age was 56.5±8.0 years in the T-group and 62.7±5.3 years in CTRL (p<0.0001). Mean follow-up was 11.0±3.2 years in the T-group and 11.1±3.3 in CTRL. Median follow-up was 12 years in the T-group and 12 years in CTRL. At baseline, alpha-blockers were used by 36.6% (T-group) and 50.2% (CTRL) (p<0.0001), 5α-reductase inhibitors by 2.1% and 8.6% (p<0.0001), and PDE5-Inhibitors by 26.4% and 22.1% (p=0.1308). IPSS (baseline: 6.4±3.7) decreased to 1.5±0.7 (p<0.0001) in the T-group in year 14. In CTRL, IPSS (baseline: 4.9±1.9) increased to 11.4±5.1 (p<0.0001). Estimated adjusted difference between groups: -11.0 (p<0.0001). Residual bladder volume (RBV) in the T-group (baseline: 50.7±25.9) decreased by 39.3±1.4 mL (p<0.0001) in year 14. In CTRL, RBV (baseline: 51.7±16.7) increased by 58.8±1.5 mL (p<0.0001). Estimated adjusted difference between groups: -94.4 mL [95% CI: -98.2;-90.7] (p<0.0001). IIEF-EF in the T-group increased from 17.3±5.9 (mild to moderate) by 11.1±0.2 to 29.5±0.9 (no ED) in year 14. In CTRL, IIEF-EF decreased from 19.7±3.5 (mild to moderate) by 14.5±0.2 to 6.8±0.9 (severe). Estimated adjusted difference between groups: 23.5 (95% CI: 23.0;24.1) (p<0.0001). QoL, assessed by the Aging Males’ Symptoms scale (AMS), improved from 53.0±9.8 (severe symptoms) by 29.8 points in the T-group to 17.2 (no symptoms) and worsened from 40.4±5.6 (moderate symptoms) by 24.7 points to 66.7 (severe symptoms) in CTRL. CONCLUSIONS: In men with functional hypogonadism, long-term TTh improves LUTS and ED sustainably over 14 years. This may have contributed to improvements in QoL. In the untreated control group, LUTS, ED, and QoL deteriorated. Source of Funding: Data entry was compensated by Bayer AG © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e675 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ahmad Haider More articles by this author Karim Sultan Haider More articles by this author Gheorghe Doros More articles by this author Abdulmaged Traish More articles by this author Expand All Advertisement PDF downloadLoading ...

Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights.

Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone to the physiologic range with testosterone therapy (TT). There are numerous forms of testosterone therapy, such as injectable, transdermal, nasal, and subcutaneous applications. There are also multiple formulations of injection, such as testosterone cypionate, testosterone enanthate, and testosterone undecanoate. Testosterone undecanoate (TU) is a long-acting ester formulation of testosterone that can be provided in an injectable or oral form. Oral testosterone undecanoate is marketed as Andriol, Jatenzo, Tlando, and Kyzatrex. Oral TU provides a convenient option for many patients, which may increase compliance with TT. Injectable testosterone undecanoate is marketed as Aveed and Nebido. Injectable TT remains the most cost-effective therapeutic option and is appropriate for most patients as an initial therapy. This review describes the pharmacokinetics of these testosterone undecanoate products and provides a guide for prescribers using these medications. While many forms of testosterone are appropriate for TT, a patient-centered discussion focused on goals of care should best guide physician prescription of these medications.

OR29-4 Prevention of Type 2 Diabetes by Testosterone in the T4DM Trial: Analysis of Effect Mediation

Abstract Background In men aged 50+ years at high risk of, or with newly diagnosed type 2 diabetes (T2D) testosterone (T) treatment reduced the risk T2D at 2-years by 40% beyond lifestyle change alone (Wittert et al Lancet Diabetes and Endocrinol 2021). Aim Determine whether changes in total fat mass (kg), abdominal fat mass (%), lean mass (kg), and non-dominant handgrip (kg) mediate the effect of T treatment on glycaemia. Hypothesis The effect of testosterone on glycaemia is mediated by changes in fat and functional skeletal muscle mass Methods: A randomised placebo-controlled trial enrolled 1007 men, 50–74 years, waist circumference (WC) ≥ 95cm, serum total T ≤ 14nmol/L (chemiluminescent RIA) and either impaired glucose tolerance or newly diagnosed T2D on an oral glucose tolerance test (OGTT). Participants were enrolled in a lifestyle program (WW) and randomised 1: 1 to 3 monthly IM injections of 1gm testosterone undecanoate or placebo. The primary outcome of T2D at 2-yrs (OGTT&amp;gt;=11.1mmol/L) was assessed by binomial regression with a log-link function. Mediators of interest were fat mass % abdominal fat, lean mass (dual x-ray absorptiometry) and non-dominant hand-grip strength (handgrip dynamometry). Mediation was determined by including the baseline and change at two years for each of the 4 factors of interest in the model. Significance: P&amp;lt; 0.05. There was no imputation for missing data. Results There were complete data for 775 men (77.5%). For the outcome of T2D at 2-yrs, the unadjusted RR for treatment was 0.59 (95% CI: 0.43–0.80), which became 0.66 (95% CI: 0.51–0.87) after adjustment for baseline values of the proposed treatment mediators and OGTT. After inclusion of changes in body composition (total fat mass, abdominal fat percentage, lean mass) and grip strength, the effect of treatment was attenuated, RR 0.85 (95% CI: 0.61–1.19). The individual effects for changes in fat mass, abdominal fat, lean mass, and grip strength were 0.88 (0.64–1.19), 0.79 (0.59–1.07), 0.52 (0.38–0.71) and 0.64 (0.48–0.86) respectively. Conclusion After including change in fat mass the RR increased and the effect of T was no longer significant indicating the decrease in fat mass mediates the effect of T. This did not however, entirely explain the effect of T to decrease risk for T2D. Although lean mass and hand grip strength increased, neither mediated the effect of testosterone on T2D. Presentation: Tuesday, June 14, 2022 10:30 a.m. - 10:45 a.m.

Comparison of Testosterone Undecanoate (TU) and Testosterone Enanthate (TE) with Combination of Depot Medroxyprogesterone Acetate (DMPA) on Spermatogenic Cells in Men

Introduction: Male hormonal contraception known as safe, effective, and reversiblecontraception. World Health Organization (WHO) multicentre study has been conducted aclinical study administrating of testosterone regimens and progestin to male with a remarkableresult. Azoospermia or severe oligozoospermia occurred in men with injection of TestosteroneEnanthate (TE) and Depot Medroxyprogesterone Acetate (DMPA) as well as TestosteroneUndecanoate (TU) and DMPA for a longer period. Decreasing gonadotropin as well astestosterone could lead to the amount of spermatogenic cells population declining by suppressingthe development of many kinds of cells. This narrative review was to compare howspermatogenic suppression in TE and TU with Combination of DMPA. Method: We arerandomly select article or journal from several databases and individual journal in certainkeywords. The keyword used were : (male hormonal contraception) OR (regimen testosterone))AND (progestin) OR (DMPA) OR (Testosterone enanthate) OR (Testosterone undecanoate) OR(male hormonal contraception combination)) AND (DMPA to spermatogenic cells) OR(Testosterone and DMPA to germ cell development)). After initial searching from databases andindividual journal website, 16 scientific articles or journals selected for the review. Result: Theresult indicated that injection of TE and DMPA had suppressed spermatogenesis, might notsuppressed sperm production for a longer period but the decreasing in type B spermatogoniauntil pachytene spermatocyte did occur. On the other hand, injection of TU and DMPA couldmaintain the suppression of sperm production for a longer period due to sustainable higher serumMPA with combination to even longer-acting TU would have more profound effect for that.Conclusion: It was known that combination of TU and DMPA might have better suppression onsperm production than TE and DMPA, otherwise further research needs to be obtained from thecombination of TU and DMPA on spermatogenic development and the association withintratesticular testosterone.

The effects of long-term testosterone treatment on endocrine parameters in hypogonadal men: 12-year data from a prospective controlled registry study

Testosterone therapy (TTh) is the primary treatment for aging men with functional hypogonadism. Whilst the benefits of testosterone (T) replacement are well-evidenced, the long-term data for TTh on metabolic and endocrine parameters is limited. Here we present the effect of TTh on endocrine parameters in hypogonadal men at a 12-year follow-up. In this single-centre, cumulative, prospective, registry study, 321 hypogonadal men (mean age: 58.9 years) received testosterone undecanoate injections in 12-week intervals for up to 12 years. Blood samples were taken at every other visit to measure levels of total T (TT), calculated free T, sex hormone-binding globulin (SHBG), estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), progesterone and prolactin. We observed an increase in TT of 15.5 nmol/L (p < 0.0001), a reduction in SHBG of 10.5 nmol/L (p < 0.0001) and an increase in calculated free T of 383.04 pmol/L (p < 0.0001) over the study period. This was accompanied by an increase in estradiol levels by 14.9 pmol/L (p < 0.0001), and decreases in progesterone (0.2 ng/mL, p < 0.0001), LH (10.4 U/L, p < 0.0001) and FSH (8.4 U/L, p < 0.0001) were demonstrated at 12-years. The levels of prolactin remained unchanged. Long-term TTh altered hormonal parameters to predictably modify the endocrine system. These effects were sustained during the entire observation time of 12 years.

1427-P: Long-Term Treatment with Testosterone Leads to Profound Weight Loss in Men with Hypogonadism and Type 2 Diabetes: Update of Real-World Data from a Registry Study

Background: Prevalence of hypogonadism in men with T2DM has been reported as high as 50%. ADA Guidelines recommend measuring testosterone in men with T2DM. Methods: Of 370 men with hypogonadism and T2DM, 302 (81.6%) were obese, 62 (16.8%) overweight and 6 (1.6%) had normal weight. 190 received injections of testosterone undecanoate 1000 mg/12 weeks (T-group) following an initial 6-week interval, 180 opted against treatment (CTRL) . Means and standard deviations of absolute measures over 13 years of treatment are reported. Results: Mean baseline age: 62.0±5.2 years, mean (median) follow-up: 9.3±3.1 (10) years. Waist circumference (cm) decreased from 117.9±14.8 to 98.2±4.3 in the T-group (p&amp;lt;0.0001) and increased in CTRL from 116.9±13.5 to 119.0±8.4 (p&amp;lt;0.0001) . Difference between groups at 13 years: 21.8 (p&amp;lt;0.0001) . Weight (kg) decreased from 114.4±13.8 to 88.3±7.6 in the T-group (p&amp;lt;0.0001) and increased in CTRL from 102.7±14.1 to 104.5±10.2 (p&amp;lt;0.0001) . Difference between groups: 21.4 (p&amp;lt;0.0001) . BMI (kg/m²) decreased from 36.5±4.4 to 28.5±2.4 in the T-group (p&amp;lt;0.0001) and increased in CTRL from 32.8±4.7 to 33.3±3.6 (p&amp;lt;0.0001) . Difference between groups: 6.9 (p&amp;lt;0.0001) . Weight change from baseline was -21.5±5.2% in the T-group and 9.3±3.0% in CTRL (p&amp;lt;0.00for both) . Difference between groups: 30.4% (p&amp;lt;0.0001) . Waist:height ratio decreased from 0.67±0.to 0.56±0.03 in the T-group and increased from 0.66±0.to 0.67±0.05) in CTRL (p&amp;lt;0.00for both) . Difference between groups: 0.12 (p&amp;lt;0.0001) . Visceral adiposity index (VAI) decreased from 5.9±3.1 to 1.8±0.4 in the T-group and increased from 5.2±2.6 to 9.1±4.4 in CTRL (p&amp;lt;0.00for both) . Difference between groups: 7.6 (p&amp;lt;0.0001) . Adherence to testosterone therapy was 100%. Conclusions: Long-term treatment with testosterone undecanoate injections results in profound weight loss maintained over up to 13 years. Untreated hypogonadal patients gain weight. Disclosure A.Haider: Other Relationship; Bayer AG. K.S.Haider: Other Relationship; Bayer AG. F.Saad: Consultant; Bayer AG, Stock/Shareholder; AbbVie Inc., Bayer AG, GlaxoSmithKline plc. Funding Bayer AG

A multimodality intervention to improve musculoskeletal health, function, metabolism, and well-being in spinal cord injury: study protocol for the FIT-SCI randomized controlled trial

BackgroundA spinal cord injury (SCI) is a devastating, life-changing event that has profoundly deleterious effects on an individual’s health and well-being. Dysregulation of neuromuscular, cardiometabolic, and endocrine organ systems following an SCI contribute to excess morbidity, mortality and a poor quality of life. As no effective treatments currently exist for SCI, the development of novel strategies to improve the functional and health status of individuals living with SCI are much needed. To address this knowledge gap, the current study will determine whether a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that consists of functional electrical stimulation of the lower extremity during leg cycling (FES-LC) plus arm ergometry (AE) administered using behavioral motivational strategies, and testosterone therapy, is more efficacious than FES-LC plus AE and placebo in improving aerobic capacity, musculoskeletal health, function, metabolism, and wellbeing in SCI.MethodsThis single-site, randomized, placebo-controlled, parallel group trial will enroll 88 community-dwelling men and women, 19 to 70 years of age, with cervical and thoracic level of SCI, ASIA Impairment Scale grade: A, B, C, or D, 6 months or later after an SCI. Participants randomized to the multimodality intervention will undergo 16 weeks of home-based FES-LC and AE training plus testosterone undecanoate. Testosterone undecanoate injections will be administered by study staff in clinic or by a visiting nurse in the participant’s home. The control group will receive 16 weeks of home-based FES-LC and AE exercise plus placebo injections. The primary outcome of this trial is peak aerobic capacity, measured during an incremental exercise testing protocol. Secondary outcomes include whole body and regional lean and adipose tissue mass; muscle strength and power; insulin sensitivity, lipids, and inflammatory markers; SCI functional index and wellbeing (mood, anxiety, pain, life satisfaction and depressive symptoms); and safety.DiscussionWe anticipate that a multimodality intervention that simultaneously addresses multiple physiological impairments in SCI will result in increased aerobic capacity and greater improvements in other musculoskeletal, metabolic, functional and patient-reported outcomes compared to the control intervention. The findings of this study will have important implications for improving the care of people living with an SCI.Trial registrationClinicalTrials.gov: (NCT03576001).Prospectively registered: July 3, 2018.

Occurrence of pulmonary oil microembolism (POME) with intramuscular testosterone undecanoate injection: literature review.

Testosterone undecanoate injections (TU), an oil-based depot, is a universal hormonal-based treatment which has been associated with pulmonary oil microembolism (POME). However, the rate of POME during routine intramuscular (IM) TU injection is unknown. Here, we conduct a peer-reviewed literature review investigating POME incidents in the setting of TU injections. A total of 48 articles were selected in the literature review, which included 29 studies that used TU and reported its effects. Relatively few POME cases were reported across multiple published studies, including those that focused particularly on the occurrence rate of POME while administrating IM TU. Of the 29 individual studies, which included 7 978 patients, eight studies reported a total of 88 incidence of POME cases or cough. This included episodes of cough that were not originally declared as POME. One post market review reported 223 cases per 3,107,652 injections. When POME did occur, almost all cases resolved spontaneously within 60 min without intervention. Overall, POME was observed to be rare.

MP35-11 LUTS, ED, AND QOL IMPROVE UNDER LONG-TERM TESTOSTERONE THERAPY IN OBESE MEN WITH FUNCTIONAL HYPOGONADISM

You have accessJournal of UrologyCME1 May 2022MP35-11 LUTS, ED, AND QOL IMPROVE UNDER LONG-TERM TESTOSTERONE THERAPY IN OBESE MEN WITH FUNCTIONAL HYPOGONADISM Ahmad Haider, Karim Sultan Haider, Gheorghe Doros, and Abdulmaged Traish Ahmad HaiderAhmad Haider More articles by this author , Karim Sultan HaiderKarim Sultan Haider More articles by this author , Gheorghe DorosGheorghe Doros More articles by this author , and Abdulmaged TraishAbdulmaged Traish More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002589.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in elderly men are closely associated with quality of life (QoL). We aimed to assess long-term effects of testosterone therapy (TTh) in obese hypogonadal men in a registry study. METHODS: Of 476 obese men with functional hypogonadism, 281 men chose TTh by means of testosterone undecanoate (TU) injections 1000 mg/12 weeks following an initial 6-week interval (T-group). 195 men opted against TTh and served as controls (CTRL). 12-year data are presented. Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the groups. RESULTS: Mean age at baseline: 59.9±5.5 years (T-group) and 62.9±5.0 (CTRL) (p <0.0001). Mean (median) follow-up: T-group 9.4±3.0 (11), CTRL 8.9±3.0 (10) years. Alpha-blockers were used at baseline by 53.7% in the T-group and 56.4% in CTRL (p=0.3963), PDE5 inhibitors by 23.1% in the T-group and 26.2% in CTRL (p=0.4501). IPSS (baseline: 7.9±3.4) decreased by 5.8±0.2 (p <0.0001) in the T-group in year 12. In CTRL, IPSS (baseline: 5.1±1.8) increased by 4.2±0.3 (p <0.0001). Estimated adjusted difference between groups: −9.3 [95% CI: −10.7; −9.3] (p <0.0001). Residual bladder volume (RBV) in the T-group (baseline: 61.1±22.8) decreased by 48.8±1.6 mL (p <0.0001) in year 12. In CTRL, RBV (baseline: 53.7±16.0) increased by 39.1±2.3 mL (p <0.0001). Estimated adjusted difference between groups: −87.3 mL [95% CI: −93.5; −81.1] (p <0.0001). IIEF-EF in the T-group increased from 17.5±5.9 (mild to moderate) by 11.1±0.3 to 29.2±1.1 (no ED) in year 12. In CTRL, IIEF-EF decreased from 18.9±3.9 (mild to moderate) by 14.4±0.4 to 7.7±1.1 (severe). Estimated adjusted difference between groups: 25.5 (95% CI: 24.5; 26.5) (p <0.0001 for all). QoL, assessed by the Aging Males’ Symptoms scale (AMS), improved from 53.7±9.5 (severe symptoms) by 31.1 points in the T-group to 16.9 (no symptoms) and worsened from 40.0±5.7 (moderate symptoms) by 21.8 points to 69.8 (severe symptoms) in CTRL. CONCLUSIONS: In obese men with functional hypogonadism, long-term TTh improves LUTS and ED sustainably over 12 years. This may have contributed to improvements in QoL. In the untreated control group, LUTS, ED, and QoL deteriorated. Source of Funding: Data entry and statistical analysis was compensated by Bayer AG © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e591 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ahmad Haider More articles by this author Karim Sultan Haider More articles by this author Gheorghe Doros More articles by this author Abdulmaged Traish More articles by this author Expand All Advertisement PDF DownloadLoading ...