BJU international
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Multicenter Study
International validation of the prognostic value of subclassification for AJCC stage pT3 upper tract urothelial carcinoma of the renal pelvis.
What's known on the subject? and What does the study add? Tumour stage is a powerful predictor of clinical outcomes and the most important factor driving clinical decision-making after radical nephroureterectomy (RNU) in upper tract urothelial carcinoma (UTUC). It has been suggested that renal pelvic pT3 subclassification into microscopic infiltration of the renal parenchyma (pT3a) versus macroscopic infiltration or invasion of peripelvic adipose tissue (pT3b) has strong prognostic value. This is an external validation study of the prognostic value of pT3 subclassification of renal pelvic UTUC in a large international cohort of patients treated with RNU. pT3b UTUC is associated with features of aggressive tumour biology, disease recurrence and cancer-specific mortality. However, pT3 subclassification is not an independent predictor of clinical outcomes. ⋯ Patients with pT3b UTUC were more likely to have tumours with aggressive pathological features and were at higher risk of disease recurrence and CSM after RNU compared with patients with pT3a disease. However, the pT3 subclassification did not remain an independent predictor of disease recurrence or CSM after controlling for tumour grade, lymph node status, tumour architecture and lymphovascular invasion.
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Multicenter Study Clinical Trial
New treatment paradigm for prostate cancer: abarelix initiation therapy for immediate testosterone suppression followed by a luteinizing hormone-releasing hormone agonist.
Study Type - Therapy (prospective cohort). Level of Evidence 2a. What's known on the subject? and What does the study add? The sequential administration of a GnRH antagonist followed by an LHRH agonist in the management of prostate cancer patients has not been studied, but such a program would provide a more physiologic method of achieving testosterone suppression and avoid the obligatory testosterone surge and need for concomitant antiandrogens that accompany LHRH agonist therapy. The current study which uses abarelix initiation therapy for 12 weeks followed by either leuprolide or goserelin demonstrates the ability to more rapidly achieve testosterone suppression, avoid the obligatory LHRH induced testosterone surge, avoid the necessity of antiandrogens, all of which were accomplished safely, without inducing either additional or novel safety issues. ⋯ • Abarelix initiation therapy results in the desired effect of achieving rapid testosterone suppression; testosterone surges after subsequent LHRH agonist therapy are greatly abrogated or completely eliminated. • This treatment paradigm (abarelix initiation followed by agonist maintenance) obviates the need for an antiandrogen. • Abarelix was well tolerated and no clinically meaningful or novel adverse events were observed during abarelix treatment or in the transition to LHRH agonist maintenance therapy.
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Randomized Controlled Trial Multicenter Study
Add-on fesoterodine for residual storage symptoms suggestive of overactive bladder in men receiving α-blocker treatment for lower urinary tract symptoms.
Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men. Flexible-dose fesoterodine as an add-on treatment significantly improved urinary frequency and symptom bother, but not urgency episodes (primary endpoint), versus add-on placebo and was well tolerated in men with persistent overactive bladder symptoms despite receiving α-blocker. ⋯ • Flexible-dose fesoterodine was well tolerated as an add-on treatment in men with persistent storage symptoms. • Changes in urgency episodes at week 12 (primary endpoint) and many secondary endpoints were not significantly different between fesoterodine and placebo add-on treatment; however, improvements in frequency and symptom bother were significantly greater with fesoterodine. • These data suggest that there remains a limited understanding of the optimal evaluation and treatment of men with LUTS.
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Randomized Controlled Trial Multicenter Study Comparative Study
Results from an international multicentre double-blind randomized controlled trial on the perioperative efficacy and safety of bipolar vs monopolar transurethral resection of the prostate.
To compare the perioperative efficacy and safety of bipolar (B-) and monopolar transurethral resection of the prostate (M-TURP) in an international multicentre double-blind randomized controlled trial using the bipolar system AUTOCON(®) II 400 ESU for the first time. ⋯ In contrast to the previous available evidence, no clinical advantage for B-TURP was shown. Perioperative efficacy, safety and secondary outcomes were comparable between study arms. The potentially improved safety of B-TURP that is attributed to the elimination of dilutional hyponatraemia risk, a risk still present with M-TURP, did not translate into a significant clinical benefit in experienced hands.
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Randomized Controlled Trial Multicenter Study
Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971](1).
What's known on the subject? and What will the study add? Erectile dysfunction is often associated with endothelial dysfunction. It is also recognized as a marker for underlying vascular disease. This study tests the hypothesis that statin therapy may improve erectile function and also reduce the risk of future cardiovascular events via a reduction in serum cholesterol and by improving endothelial function. The study will also determine whether the treatment improves quality of life related to sexual function. ⋯ • If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD.