Resident training in urology: Bipolar transurethral resection of the prostate - a safe method in learning endoscopic surgical procedure

Introduction: Modern medicine uses increasingly innovative techniques that require more and more capabilities for acquisition. In the urological department is increasing the presence of patients with lower urinary tract symptoms (LUTS) and transurethral resection of the prostate (TURP) is the standard of care in their surgical treatment. We report our surgical experience and learning curve of using bipolar plasmakinetic devices in the training of urological residents to benign prostatic hyperplasia (BPH) treatment. Materials and Methods: 80 patients with benign prostatic enlargement due to BPH were enrolled in the study. TURP has been performed by three urological residents and by an expe- rienced urologist. Patients were evaluated before and 6 months after the endoscopic bipolar plasmakinetic resection using the International Prostate Symptom Score (IPSS), maximum uri- nary flow rate (Qmax), postvoid residual urine (PVR) and prostate specific antigen (PSA). Results: Overall 60 procedures were performed, 18 PlasmaKinetic (PK)-TURP procedures were completed by the three residents. In the other 42 cases the procedures were completed by the experienced urologist. In eight cases there was a capsular perforation and the experienced urol- ogist replaced the resident to complete the resection. No complications have been reported in the procedures completed by the senior urologist. All complications caused by the residents were man- aged intraoperatively without changing the course of the procedure. Statistical differences were observed regarding IPSS, quality of life (QoL), and PVR at 6-month follow-up when procedures completed by urological residents were compared to those completed by the senior urologist. Conclusion: Bipolar device represents appropriate tools to acquire endoscopic skills. It is safe and it can be used at the first experience of BPH treatment by a resident who has not previ- ously approached this endoscopic surgical procedure

Raloxifene reduces urokinase-type plasminogen activator-dependent proliferation of synoviocytes from patients with rheumatoid arthritis

Extracellular fibrinolysis, controlled by the membrane-bound fibrinolytic system, is involved in cartilage damage and rheumatoid arthritis (RA) synovitis. Estrogen status and metabolism seem to be impaired in RA, and synoviocytes show receptors for estrogens. Our aims in this study were to evaluate in healthy and RA synoviocytes the effects of Raloxifene (RAL), a selective estrogen receptor modulator (SERM), on: proliferation; the components of the fibrinolytic system; and chemoinvasion. The effects of RAL were studied in vitro on synoviocytes from four RA patients and four controls. Proliferation was evaluated as cell number increase, and synoviocytes were treated with 0.5 μM and 1 μM RAL with and without urokinase-plasminogen activator (u-PA) and anti-u-PA/anti-u-PA receptor (u-PAR) antibodies. Fibrinolytic system components (u-PA, u-PAR and plasminogen activator inhibitor (PAI)-1) were assayed by ELISA with cells treated with 0.5 μM and 1 μM RAL for 48 h. u-PA activity was evaluated by zymography and a direct fibrinolytic assay. U-PAR/cell and its saturation were studied by radioiodination of u-PA and a u-PA binding assay. Chemoinvasion was measured using the Boyden chamber invasion assay. u-PA induced proliferation of RA synoviocytes was blocked by RAL (p < 0.05) and antagonized by antibodies alone. The inhibitory effect of RAL was not additive with u-PA/u-PAR antagonism. RA synoviocytes treated with RAL showed, compared to basal, higher levels of PAI-1 (10.75 ± 0.26 versus 5.5 ± 0.1 μg/10(6 )cells, respectively; p < 0.01), lower levels of u-PA (1.04 ± 0.05 versus 3.1 ± 0.4 ng/10(6 )cells, respectively; p < 0.001), and lower levels of u-PAR (11.28 ± 0.22 versus 23.6 ± 0.1 ng/10(6 )cells, respectively; p < 0.001). RAL also significantly inhibited u-PA-induced migration. Similar effects were also shown, at least partially, in controls. RAL exerts anti-proliferative and anti-invasive effects on synoviocytes, mainly modulating u-PAR and, to a lesser extent, u-PA and PAI-1 levels, and inhibiting cell migration and proliferation

Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study.

BackgroundOnce-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments.ObjectivesTo evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed.MethodsIn two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose.ResultsAmong 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P&lt;0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant.ConclusionsAssessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ≥ 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity