Daily use of sildenafil 50mg at night effectively ameliorates nocturia in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: an exploratory multicenter,double-blind,randomized, placebo-controlled study

Purpose: To compare the efficacy and safety of sildenafil 25?mg qd, 25?mg bid or 50?mg qd – on treating lower urinary tract symptoms with benign prostatic hyperplasia (LUTS/BPH).

Materials and methods: Men aged?>?45 years with LUTS/BPH were randomly assigned to receive sildenafil 25?mg qd (n?=?42), bid (n?=?41), 50?mg qd (n?=?38) or placebo (n?=?41) for 8 weeks. Changes from baseline in International Prostate Symptom Score (I-PSS), maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) were assessed at week 4 and week 8.

Results: Sildenafil 25?mg qd (-7.3?±?5.8) and 25?mg bid (-7.0?±?5.7) exhibited significant improvements of I-PSS compared to placebo (-5.2?±?6.4) (p?=?0.020, 0.025, respectively). In particular, voiding domain was more affected than storage domain. Only sildenafil 50?mg qd improved nocturia significantly (versus placebo, p?=?0.027). Quality of life score was improved in all treatment groups. Q_max and PVR did not change significantly in all groups. All regimens were well tolerated.

Conclusions: Sildenafil 25?mg qd, 25?mg bid and 50?mg qd are safe and effective to improve LUTS/BPH in long term, along with coexisting ED. In particular, nocturia is most well-controlled by 50?mg qd.     

Androgen replacement therapy contributes to improving lower urinary tract symptoms in patients with hypogonadism and benign prostate hypertrophy: a randomised controlled study

Purpose.?We performed a randomised controlled study regarding the effects of androgen replacement therapy (ART) on lower urinary tract symptoms (LUTS) in hypogonadal men with benign prostate hypertrophy (BPH).

Methods.?Fifty-two patients with hypogonadism and BPH were randomly assigned to receive testosterone (ART group) as 250?mg of testosterone enanthate every 4 weeks or to the untreated control group. We compared International Prostate Symptom Score (IPSS), uroflowmetry data, post-voiding residual volume (PVR) and systemic muscle volume at baseline and 12 months after treatment.

Results.?Forty-six patients (ART group, n?=?23; control, n?=?23) were included in the analysis. At the 12-month visit, IPSS showed a significant decrease compared with baseline in the ART group (15.7?±?8.7 vs. 12.5?±?9.5; p?<?0.05). No significant changes were observed in the control group. The ART group also showed improvement in maximum flow rate and voided volume (p?<?0.05), whereas no significant improvements were observed in the controls. PVR showed no significant changes in either group. In addition, the ART group showed significant enhancement of mean muscle volume (p?<?0.05), whereas no significant changes were seen in the controls.

Conclusion.?ART improved LUTS in hypogonadal men with mild BPH.     

Dutasteride improves bone mineral density in male patients with lower urinary tract symptoms and prostatic enlargement: a preliminary study

Introduction: We studied the effect of dutasteride on bone mineral density (BMD) in aging male patients with lower urinary tract symptoms (LUTS) and prostatic enlargement.

Methods: We prospectively studied 17 patients with LUTS and prostatic enlargement. Before and 1 year after dutasteride (0.5?mg daily), we assessed International Prostate Symptom Score (IPSS), prostatic volume (PV), serum prostatic-specific antigen (PSA) and testosterone. BMD in the lumbar and femur was measured by DEXA method.

Results: Dutasteride significantly reduced PV (from 51?±?24 to 34?±?17?ml, p?p?p?2, p?2, p?2, p?Conclusions: Dutasteride has a potential to improve BMD with elevation of serum testosterone in aging male patients with LUTS and prostatic enlargement.     

Administration of daily 5 mg tadalafil improves endothelial function in patients with benign prostatic hyperplasia

Introduction: Tadalafil is a promising phosphodiesterase (PDE) 5 inhibitor prescribed for erectile dysfunction (ED). Daily low dose (5?mg) of tadalafil has also been used for the treatment of male lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH). PDE5 inhibitors induce relaxation of smooth muscle cells in the urethra, prostate, bladder neck, and blood vessels. The aim of this study was to investigate the efficacy of tadalafil on vessels endothelial function, in patients with male LUTS symptoms associated with BPH.

Methods: The Institutional Review Board (IRB) approved this clinical study and informed consents had been obtained from 81 BPH patients.

The following male LUTS parameters: international prostate symptom score (IPSS), overactive bladder symptom score (OABSS), voiding volume, max and mean voiding flow on voiding flowmetry examination and post-voiding residual urine (RU) were compared at 0, 1, 3, 6, and 12 months after a daily dose of 5?mg tadalafil.

In addition, erectile function was evaluated by the sexual health inventory for men (SHIM) score and vessels endothelial function and peripheral neuropathy were assessed by the brachial-ankle pulse wave velocity (baPWV), ankle brachial index (ABI), and vibration perception threshold (VPT) at 0, 3, 6, and 12 months after treatment.

Results: The mean age of 81 patients was 66.4?±?11.4 years old. Their prostate size was 30.2?±?22.1?ml.

Male LUTS parameters including IPSS, OABSS, and RU showed significant improvement from 1 to 12 months after tadalafil administration. Max and mean voiding flow was significantly increased at 6 months after tadalafil treatment.

The SHIM score showed significant improvement after 3 months. Whilst, the results of baPWV also showed significant improvement from 3 to 12 months. ABI was also significantly improved at 6 months. However, there was no change in the VPT at any time point.

Conclusions: Tadalafil is effective for both male LUTS and ED. It is also shown that tadalafil improves baPWV, which we can conclude that higher vessels elasticity has been obtained. This major finding of this study shows that tadalafil has the potency to improve vessels endothelial dysfunction in patients with BPH.     

The impact of atherosclerosis on lower urinary tract function

Abstract

Objective: The current study was carried out to investigate the impact of atherosclerosis on lower urinary tract function in the male patients with lower urinary tract symptoms (LUTS).

Patients and methods: This prospective study evaluated 110 male patients aged 55–75 years who were presented with LUTS. All patients underwent general and local investigations. The atherosclerosis was assessed by ultrasound examination of the carotid artery. Patients then were divided into two groups: non-atherosclerosis group (Group 1) and atherosclerosis group (Group 2). The two groups were compared regarding voiding and storage parameters.

Results: Mean patient age were 67.9?±?5.9 years. The average age and number of Group 1 was 65.7?±?4.3, n?=?51. The average age and number of Group 2 was 68.7?±?5.3, n?=?59. There were no significant differences in age, prostate volume, blood pressure, International Prostate Symptom Score, Voiding symptom score and Storage symptom score between the two groups. Blood serum triglycerides were significantly lower in Group 1 than Group 2 while HDL cholesterol were significantly higher in Group 1 than Group 2 0.97?±?0.5 and 1.43?±?0.2?mmol/L, versus 1.46?±?0.7 and 1.28?±?0.3?mmol/L, respectively. Qmax denotes significant decrease in Group 2 compared with Group 1 12.5?±?6.3 versus 17.6?±?6.5, respectively (p?<?0.01). While in post-voiding residual urine, there was a significant increase in Group 2 compared with Group 1 82.2?±?15.4 versus 51.4?±?12.7, respectively (p?<?0.01). Daytime voided urine denotes a significant decrease in Group 2 176?±?48, compared with Group 1 221.2?±?79 (p?<?0.01). Daytime frequency and nocturia, were significantly higher in Group 2, compared with Group 1 8.90?±?2.8 versus 7.16?±?3.11, respectively, and 3.1?±?1.2 versus 1.92?±?1.12, respectively (p?<?0.05).

Conclusion: The atherosclerosis disease play a significant role in the impairments of both voiding and storage function in male patients with LUTS irrelevant to the age.     

The effect of testosterone therapy on lower urinary tract symptoms/bladder and sexual functions in men with symptomatic late-onset hypogonadism

Objective.?To prospectively investigate the effect of testosterone therapy on lower urinary tract symptoms (LUTS)/bladder and sexual functions in men with symptomatic late-onset hypogonadism (SLOH).

Methods.?The study included 25 men (age range 38 to 73 years) presented with sexual dysfunction, having SLOH, at a single university hospital. All men received testosterone replacement therapy with transdermal testosterone 50–100 mg gel per day for one year. Urodynamic studies with pressure-flow analysis, measurement of prostate volume, prostate specific antigen (PSA) and free PSA level, International Prostate Symptom Score (IPSS), Aging Male Symptom (AMS) scale and International Index of Erectile Function (IIEF-5) score were recorded in all men before and after one year of the treatment.

Results.?The mean AMS score significantly decreased from 40.4 ± 7.3 to 28.8 ± 5.31 (p = 0.001), and mean IIEF-5 score significantly increased from 8.84 ± 3.76 to 14.36 ± 3.62 (p = 0.001). The mean maximal bladder capacity and compliance significantly increased (p = 0.007 and p = 0.032, respectively), and mean detrusor pressure at Qmax significantly decreased from pre-treatment to post-treatment (p = 0.017).

Conclusion.?This study suggests that in addition to improvement in sexual functions, testosterone therapy may also improve LUTS/bladder functions by increasing bladder capacity and compliance and decreasing detrusor pressure at maximal flow in men with SLOH.     

The impact of irritative lower urinary tract symptoms on erectile dysfunction in aging Taiwanese males

Objective.?This study assessed the possible associations between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) in aging Taiwanese males and investigated the impact of various aspects of LUTS on ED.

Methods.?A free health screening for aging males (≥40 years old) was conducted in Kaohsiung Medical University Hospital. All the subjects had completed clinical data and answered questionnaires. ED and LUTS were assessed by validated symptom scales: the International Index of Erectile Function-5 (IIEF-5) and the International Prostate Symptom Score (IPSS).

Results.?A total of 339 eligible patients enrolled in this study with a mean age of 60.1 years old. In multiple logistic regression analysis, age and IPSS (p?<?0.001 and p?=?0.013, respectively) were significantly associated with ED after controlling other comorbidities. In a further age-adjusted multiple regression analysis, our results showed that irritative symptoms (p?=?0.042) have a more significant association with ED than the obstructive symptoms (p?=?0.101).

Conclusions.?Our results indicate that age and LUTS are the two most independent risk factors for ED. Aging Taiwanese males with LUTS are at increasing risk for ED, especially for those with significant irritative symptoms.     

Effect of ageing on the efficacy efficiency of TUVRP

Introduction: To evaluate the effect of ageing on the efficacy of transurethral vaporization resection of the prostate (TUVRP). Methods: The clinical outcomes of 285 patients treated by TUVRP were retrospectively analyzed. Patients were divided into three groups by age, Group A with 91 patients less than ≤70 years of age, Group B with 127 patients from 71 to 79 years of age, and Group C with 67 patients greater than ≥80 years of age. Results: Prostate volume was 53.1?±?24.1?ml in Group A, 67.8?±?39.7?ml in Group B and 60.0?±?43.9?ml in Group C (p < 0.001). More co-existent systemic diseases were identified in Group C than in the other two groups (p < 0.001). American Society of Anesthesiologists (ASA) grade increased with age (p < 0.001). Urological comorbidities associated with BPH, operating time, IPSS score, and QOL index were not different among the three groups. A significant difference was observed in before and after surgery IPSS score, QOL index, and maximum urinary flow rate (Qmax), in all three groups (p < 0.05). Post-operative Qmax decreased with age (p < 0.05). Conclusion: TUVRP was safe and effective for the patients greater than 80 years of age, similarly to younger patients. Advanced aged was not a contraindication for surgery, and did not increase the difficulty of the procedure.     

Folate: a possible role in erectile dysfunction?

A growing body of evidence suggests a role for homocysteine (Hcys) and folate (FA) in erectile function (EF): Hcys appears to impair EF affecting endothelium via several mechanism whereas the role of FA remains to be elucidated, besides decreasing Hcys. To assess correlation between erectile dysfunction (ED) and serum levels of FA, Hcys, and B12, we enrolled 31 patients affected by ED (Group A; age 52.83?±?11.89 years) and 31 healthy adults (Group B; age 49.14?±?13.63 years). Fasting blood samples were taken for each subject. ED was assessed by the International Index of Erectile Function-5 (IIEF-5). IIEF-5 mean score was significantly lower in Group A than in Group B (10.71?±?4.24 versus 23.32?±?1.33, p?p?p?相似文献   

Comparison of the effectiveness of IPSS and VPSS without any help in LUTS patients: a prospective study

Aim: To compare the correlation of visual prostate symptom score (VPSS) and international prostate symptom score (IPSS). To investigate the effect of educational level and age in the responses to VPSS and IPSS.

Method: Three hundred and nine patients who gave consent and applied via LUTS to our institution were included in this study. They were requested to fill IPSS and VPSS. The patients were divided into two groups as middle-aged and elderly with a cutoff point of 65?years. They were divided into six groups based on educational level. SPSS was used for the statistical evaluation.

Results: The mean age of the patients was 61.5?±?8.9?years. The correlation was found between IPSS and VPSS (p?p?=?.332 and .138, respectively). No difference was found between the middle-aged and elderly groups in terms of the rates of inability to answer IPSS and VPSS (p?=?.177 and .681, respectively).

Conclusions: There is a correlation between VPSS and IPSS. VPSS can be used as an auxiliary or alternative tool instead of IPSS in evaluating LUTS; however, has no superiority to IPSS in elderly group. Currently, the best option to exclude bias in illiterate group is VPSS.     

The relationship between serum total testosterone and free testosterone levels with serum hemoglobin and hematocrit levels: a study in 1221 men

Objective: To investigate the relationship between serum total testosterone (TT) and free testosterone (FT) levels in men with anemia.

Methods: We reviewed the records of 1221 subjects between March 2009 and December 2014. All the subjects’ blood samples were drawn for TT and FT assays. Their serum hemoglobin (Hb) and serum hematocrit (Hct) levels were measured. The primary objective of our study was to investigate the association between TT and FT levels with Hb and Hct levels.

Results: The mean age was 59.82?±?12.71 years. The mean TT and FT levels were 4.54?±?2.02?ng/mL and 10.63?±?3.69?pg/mL, respectively. The mean Hb and Hct levels were 14.72?±?1.34?g/dL and 43.11?±?3.75%, respectively. Subjects with low TT (<2.35?ng/mL) had low Hb and Hct levels (p?p?Conclusions: Subjects with low TT and FT levels had low Hb and Hct levels. This suggests that TT and FT play a significant role in erythropoiesis. Testosterone replacement therapy may be effective in men with hypogonadism to reduce the incidence of anemia.     

The imbalance of sex-hormones related to depressive symptoms in obese men

Obese men may present hypogonadothrofic hypogonadism, mainly related to higher insulinemia and aromatase activity. Our objectives were to evaluate the relationship of sex-hormones profiles and frequency of depressive symptoms in 43 obese men, in a cross-sectional study. They had 19–60 years, and body mass index 30–50?kg/m². LH, total and free testosterone (TT and FT), estradiol (E₂), sex hormone binding globulin, estradiol/total testosterone ratio (E₂/T) were analyzed. Depressive symptoms were evaluated by “beck depression inventory” (BDI), and significant depression was considered if BDI?≥?16.Thirty-four (80%) presented low TT levels, but only 4 (14%) had low free testosterone and hypogonadism symptoms; 12 of 43 (28%) presented increased E₂. Forty five (56%) presented depressive symptoms, but 16 (28% of the 45) had significant depression. BDI correlated positively with E₂ (r?=?0.407; p?=?0.001) and E₂/T (r?=?0.473; p?=?0.001), but not TT or FT. Patients with significant depressive showed higher levels of estradiol (136?±?48 versus 103?±?48?pg/ml, p?=?0.02) and E₂/T (16.0?±?9.9 versus 9.8?±?4.6; p?=?0.002) (mean?±?SD).In conclusion, obese men may present relatively excess of estradiol and deficiency in testosterone, leading to an imbalance between these two hormones. The greater this imbalance, the more depressive symptoms had our patients.     

Interleukin-18 and testosterone levels in men with metabolic syndrome

Objective: Interleukin 18 (IL-18) is an adipokine associated with obesity. Data about the relationship of IL-18 to the metabolic syndrome (MS) are still scarce. Low testosterone (T) levels are common in men with MS, but we did not find data about the levels of IL-18 in men with low T. The aim of this study was to determine the levels of IL-18 in men with MS with or without low T.

Patients and methods: A total of 251 men were included in the study. Of them 218 had MS (IDF 2005) and they were divided according to their morning total testosterone (TT) level (cutoff 10.4?nmol/l) into two groups: MS-low T (N?=?84) and MS-normal T (N?=?134). The control group consisted of 33 men without MS and low T. IL-18 was determined in serum using enzyme-linked immunosorbent assay. A small group of eight men with MS and low T levels received testosterone therapy for three months and physical and laboratory parameters were monitored at the end of that period.

Results: MS men were at mean age (±SD)?=?53.77?±?9.59 years; body mass index (BMI)?=?34.0?±?6.3?kg/m²; and TT?=?12.59?±?5.66?nmol/l. The control group was at age?=?52.12?±?5.2 years (NS); BMI?=?25.6?±?2.4?kg/m² (p?p?p?p?p?p?Conclusions: In this study, higher IL-18 levels were found in the presence of MS compared to healthy men, but they did not differ between men having MS with or without LOH.     

Can the UroLift prostatic implant device treat the symptoms of benign prostatic hypertrophy,avoid sexual dysfunction and reduce hospital TURP waiting times? A single centre,single surgeon experience and review of the literature

BPH associated with LUTS and sexual dysfunction is common. We performed UroLift on 11 patients, average age 71?years (range 56–90). IPSS improved by an average of 9 points post-procedure. Pre-operatively their post-void residuals were 306.3?ml (range 120–499?ml SD [120.6]) and their Q_MAX was 7?ml/s (range 4–14 SD [2.8] ml/s). Post-procedure the post-void residual decreased by 35.4% at 4?months (mean difference – 106.3?ml). Q_MAX improved by an average of 1.7?ml/s, which was not statistically significant. No patients suffered any sexual dysfunction side effects and all patients were satisfied with their result. Hospital stay and theatre time were significantly reduced. Average length of stay was just 10.6 (6–18) hours and average theatre time just 18.7 (12–30) min. This is significantly faster than other surgery for LUTS. We therefore feel that there are significant benefits for both the patients, who are able to go home much faster, and also the hospital, who are able to perform far more surgeries for their patients. Patients also do not require an inpatient bed so patients should not be cancelled on the day of theatre.     

The role of sex steroid hormones in benign prostatic hyperplasia

Introduction: The etiology of benign prostatic hyperplasia (BPH) remains a mystery to scientists; estrogen/androgen imbalance in aged men has been implicated.

Methods: Thirty (30) apparently healthy men and newly diagnosed BPH patients were recruited from the Ghana Police Hospital. Lower urinary tract syndrome (LUTS) and prostate volume were assessed via the prostate symptom score sheet (IPSS) and abdominopelvic scan, respectively. Laboratory assays for total prostate specific antigen (tPSA) and hormones [androstenedione (AED), testosterone (T), dihydrotestosterone (DHT), androstanedioladiol (3α-adiol), androstanediol (3β-diol), estrone (E1) and estradiol (E2)] were performed via ELISA techniques. Non-parametric analyses were employed. p?Results: AED was significantly higher in controls compared to the BPH patients. AKRIC2 (3α-diol/DHT) was significantly higher in the BPH group (p?p=?0.029). Age correlated negatively with T, while a negative correlation was observed between TIPSS and 3β-diol and AKRIC1. Also, prostate volume correlated negatively with fT.tPSA correlated positively with E2 and aromatase activity (E2/T) and negatively with fT. On multiple linear regression, DHT and 3β-diol remained independent predictors for TIPSS and fT for tPSA.

Conclusion: Estrogens and androstanediols seem to play a role in BPH development.     

Low skeletal muscle mass index is associated with function and nutritional status in residents in a Turkish nursing home

Introduction: To determine the prevalence of low muscle mass (LMM) and the relationship between LMM with functional and nutritional status as defined using the LMM evaluation method of European Working Group on Sarcopenia in Older People (EWGSOP) criteria among male residents in a nursing home.

Methods: Male residents aged?>60 years of a nursing home located in Turkey were included in our study. Their body mass index (BMI) kg/m², skeletal muscle mass (SMM-kg) and skeletal muscle mass index (SMMI-kg/m²) were calculated. The participants were regarded as having low SMMI if they had SMMI?<9.2?kg/m² according to our population specific cut-off point. Functional status was evaluated with Katz activities of daily living (ADL) and Lawton Instrumental Activities of Daily Living (IADL). Nutritional assessment was performed using the Mini Nutritional Assessment (MNA). The number of drugs taken and chronic diseases were recorded.

Results: One hundred fifty-seven male residents were enrolled into the study. Their mean age was 73.1?±?6.7 years with mean ADL score of 8.9?±?2.0 and IADL score of 8.7?±?4.6. One hundred twelve (71%) residents were aged?>70 years. Thirty-five men (23%) had low SMMI in group aged?>60 years, and twenty-eight subjects (25%) in the group aged?>70 years. MNA scores were significantly lower in residents with low SMMI compared with having normal SMMI (17.1?±?3.4 versus 19.6?±?2.5, p?=?0.005). BMI was significantly lower in the residents with low SMMI compared with normal SMMI (19.6?±?2.7 versus 27.1?±?4.1, p70 years (8.1?±?2.6 versus 9.1?±?1.6, p?=?0.014). In regression analyses, the only factor associated with better functional status was the lower age (p?=?0.04) while the only factor associated with better nutrition was higher SMMI (p?=?0.01).

Conclusions: Low SMMI detected by LMM evaluation method of EWGSOP criteria is prevalent among male nursing home residents. There is association of low SMMI with nutritional status and probably with functional status within the nursing home setting using the EWGSOP criteria with Turkish normative reference cut-off value.     

The effect of testosterone treatment on prostate histology and apoptosis in men with late-onset hypogonadism

Objectives: To investigate the effect of testosterone replacement therapy (TRT) on prostate histology and apoptosis in men with late-onset hypogonadism (LOH).

Methods: The study included 25 men, having LOH with prostate-specific antigen (PSA) level of 4?ng/ml or less. All patients underwent transrectal ultrasound guided prostate biopsy at baseline, and received testosterone undecanoate treatment for 1 year. Prostate biopsy was repeated at the end of 1 year of testosterone therapy. In addition to clinical and biochemical parameters, prostate histology and apoptotic index (AI) were compared before and after the TRT.

Results: The mean serum total testosterone significantly increased from 178.04?±?51.92 to 496.28?±?103.73?ng/dl (p?=?0.001). No significant differences were observed in serum total and free PSA level, prostate volume and maximal urinary flow rate. There were also no significant differences in AI, stroma/epithelial cells ratio, Ki-67 positive cells and atrophy score of prostate tissue before and after the TRT.

Conclusions: This study demonstrated that TRT did not affect serum PSA level, prostate volume and maximal urinary flow rate. This study also suggests that TRT does not cause the risk for prostate cancer development, because of no significant differences in prostate histology after TRT.     

Impact of metabolic syndrome on erectile dysfunction and lower urinary tract symptoms in benign prostatic hyperplasia patients

Introduction.?The aim of this study was to investigate the relationship among metabolic syndrome (MetS), erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH).

Methods.?Our study included 106 patients with BPH, 33 (31.1%) of whom had MetS. Blood pressures, waist circumferences, serum levels of fasting blood glucose, high density lipoprotein and triglyceride of patients were recorded. Erectile functions of the patients were evaluated by International Index of Erectile Function (IIEF). Patients were divided into two groups according to IIEF scores, namely ‘mild/no ED’ and ‘moderate/severe ED’. IIEF scores of ED groups were between 17 and 30 and 6–16 in turn. LUTS severities were assessed by International Prostate Symptom Score (IPSS) and classified as mild (IPSS 0–7), moderate (IPSS 8–19) and severe (IPSS 20–35).

Results.?There was a significant difference between ED groups concerning MetS presence (p?=?0.032). MetS presence was not found to be associated with the severity of LUTS (p?=?0.144). There was no correlation between ED groups regarding LUTS severity (p?=?0.303).

Conclusion.?Results of the present study showed a correlation between MetS presence and ED. In the light of our results, MetS seems to play an important role in the etiopathogenesis of ED in patients with BPH.     

A randomized,double-blind,placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up

Introduction: The clinical significance of low to low-normal testosterone (T) levels in men remains debated. Aim: To analyze the effects of raising serum T on lean body mass (LBM), fat mass (FM), total body mass, and health-related quality-of-life (HRQoL). Methods: Randomized, double-blind, placebo-controlled study. Men, aged 50–80 years, with serum total T<15 nmol/L and bioavailable T < 6.68 nmol/L, and a Aging Males’ Symptoms (AMS) total score >36, received 6 months treatment with transdermal 1% T gel (5–7.5?mg/day; n =183) or placebo gel (n =179), followed by 12 months open-label with T in all. Results: After 6 months, LBM increased in T- treated patients by 1.28?±?0.15?kg (mean ± SE) and FM decreased by 1.16?±?0.16?kg, with minor changes with placebo (LBM +0.02?±?0.10?kg and FM ?0.14?±?0.12?kg; all p < 0.001, T group vs. placebo). Changes were largely similar across subgroups of age, baseline total testosterone, and baseline BMI. Total HRQoL improved compared with placebo (p < 0.05, T group vs. placebo). Conclusions: Six months 1% T gel improved body composition and HRQoL in symptomatic men with low to low-normal T, with further improvements over the following 12 months.