Sensitivity as outcome measure of androgen replacement: the AMS scale

BACKGROUND: The capacity of the AMS scale as clinical utility and as outcome measure still needs validation. METHODS: An open post-marketing study was performed by office-based physicians in Germany in 2004. We analysed data of 1670 androgen-deficient males who were treated with testosterone gel. The AMS scale was applied prior to and after 3 months treatment. RESULTS: The improvement of complaints under treatment relative to the baseline score was 30.7% (total score), 27.3% (psychological domain), 30.5% (somatic domain), and 30.7% (sexual domain), respectively. Patients with little or no symptoms before therapy improved by 9%, those with mild complaints at entry by 24%, with moderate by 32%, and with severe symptoms by 39% – compared with the baseline score. We showed that the distribution of complaints of testosterone deficient men before therapy almost returned to norm values after 12 weeks of testosterone treatment. Age, BMI, and total testosterone level at baseline did not modify the positive effect of androgen therapy. We also demonstrated that the AMS results can predict the independent (physician's) opinion about the individual treatment effect. Both, sensitivity (correct prediction of a positive assessment by the physician) and specificity (correct prediction of a negative assessment by the physician) were over 70%, if about 22% improvement of the AMS total score was used as cut-off point. CONCLUSION: The AMS scale showed a convincing ability to measure treatment effects on quality of life across the full range of severity of complaints. Effect modification by other variables at baseline was not observed. In addition, results of the scale can predict the subjective clinical expert opinion on the treatment efficiency

Erectile dysfunction, physical activity and metabolic syndrome: differences in markers of atherosclerosis

<p>Abstract</p> <p>Background</p> <p>Erectile dysfunction (ED), impaired arterial elasticity, elevated resting heart rate as well as increased levels of oxidized LDL and fibrinogen associate with future cardiovascular events. Physical activity is crucial in the prevention of cardiovascular diseases (CVD), while metabolic syndrome (MetS) comprises an increased risk for CVD events. The aim of this study was to assess whether markers of subclinical atherosclerosis are associated with the presence of ED and MetS, and whether physical activity is protective of ED.</p> <p>Methods</p> <p>57 MetS (51.3 ± 8.0 years) and 48 physically active (PhA) (51.1 ± 8.1 years) subjects participated in the study. ED was assessed by the International Index of Erectile Function (IIEF) questionnaire, arterial elasticity by a radial artery tonometer (HDI/PulseWave™ CR-2000) and circulating oxLDL by a capture ELISA immunoassay. Fibrinogen and lipids were assessed by validated methods. The calculation of mean daily energy expenditure of physical exercise was based on a structured questionnaire.</p> <p>Results</p> <p>ED was more often present among MetS compared to PhA subjects, 63.2% and 27.1%, respectively (p < 0.001). Regular physical exercise at the level of > 400 kcal/day was protective of ED (OR 0.12, 95% CI 0.017-0.778, p = 0.027), whereas increased fibrinogen (OR 4.67, 95% CI 1.171-18.627, p = 0.029) and elevated resting heart rate (OR 1.07, 95% CI 1.003-1.138, p = 0.04) were independently associated with the presence of ED. In addition, large arterial elasticity (ml/mmHgx10) was lower among MetS compared to PhA subjects (16.6 ± 4.0 <it>vs</it>. 19.6 ± 4.2, p < 0.001), as well as among ED compared to non-ED subjects (16.7 ± 4.6 <it>vs</it>. 19.0 ± 3.9, p = 0.008). Fibrinogen and resting heart rate were highest and large arterial elasticity lowest among subjects with both MetS and ED.</p> <p>Conclusions</p> <p>Markers of subclinical atherosclerosis associated with the presence of ED and were most evident among subjects with both MetS and ED. Thus, especially MetS patients presenting with ED should be considered at high risk for CVD events. Physical activity, on its part, seems to be protective of ED.</p> <p>Trial registration</p> <p>ClinicalTrials.gov <a href="http://www.clinicaltrials.gov/ct2/show/NCT01119404">NCT01119404</a></p

Carefully selected intratesticular lesions can be safely managed with serial ultrasonography

OBJECTIVE To evaluate a policy of conservative non-operative management for incidental, impalpable, &lt; 1 cm, intratesticular pathology. PATIENTS AND METHODS We retrospectively reviewed all scrotal ultrasonograms within an 8-year period to identify all radiological lesions of &lt; 1 cm within the testis. All palpable lesions and those accompanied by elevated tumour markers or disseminated malignancy were managed surgically. The remaining incidentally detected lesions were followed with a protocol of serial ultrasonography (US). RESULTS Of 1544 scans reviewed, 12 (0.8%) lesions suitable for observational management were identified. The mean (range) age of the patients was 54 (34-76) years. The indication for US was suspected epididymitis in five, contralateral epididymal cyst in five and infertility in two patients. The mean (range) size of the lesion was 4.9 (1.5-9.8) mm. Three anechoic lesions were consistent with intratesticular cysts, and each was followed with no change to a mean (range) follow-up of 26 (12-48) months. Eight hypoechoic lesions were followed to a mean of 34 (4-72) months, and only one showed growth on repeat US after an interval of 4 months, and was diagnosed as a 1.0-cm seminoma after orchidectomy. One hyperechoic lesion remains unchanged at 6 months of follow-up. CONCLUSION Supported by previous reports suggesting that most testis lesions of &lt; 1 cm are benign, we managed a series of carefully selected intratesticular lesions conservatively, the behaviour in most being in keeping with benign pathology