BJU international
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Randomized Controlled Trial Comparative Study
Bipolar plasma enucleation of the prostate vs open prostatectomy in large benign prostatic hyperplasia cases - a medium term, prospective, randomized comparison.
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: According to the EAU Guidelines 2012, large size benign prostatic hyperplasia (BPH) cases (>80 mL) continue to have open prostatectomy as the first line treatment alternative, despite the substantial peri-operative morbidity and extended catheterization and convalescence periods related to this undoubtedly invasive approach. During the past two decades, holmium laser enucleation of the prostate was constantly described as a successful choice for this category of patients. According to rather numerous studies, the technique displayed superior results in terms of surgical safety and postoperative recovery compared with the open procedure. On the other hand, the concept of electrosurgical enucleation of the prostate, using either a monopolar or bipolar cutting current, materialized into several technical applications that eventually failed to gain general acknowledgement as reliable alternatives to the BPH transurethral approach. While keeping in mind the already proved advantage of enucleating substantial quantities of BPH tissue, bipolar plasma enucleation of the prostate was introduced as a novel endoscopic approach in cases of large prostates. The present trial represents the first prospective, medium-term, randomized comparison to be published of this innovative technique with standard open prostatectomy. Basically, the premises for a viable alternative relied on the practical advantages provided by the 'button' electrode, mainly the large surface creating the conditions for a fast enucleation process, continuous vaporization and concomitant haemostasis. Eventually, it was concluded that the plasma enucleation procedure distinguished itself as a successful treatment option in large BPH patients, characterized by good surgical efficiency, significantly reduced complications, faster postoperative recovery, similar prostatic tissue ablation capabilities and satisfactory follow-up results compared with the open technique. Most importantly, plasma-button enucleation patients benefited from a similar 12 months' outcome from the perspectives of symptom scores and voiding parameters when drawing a parallel with open surgery results, thus underlining the reliable viability of this type of endoscopic approach. ⋯ BPEP represents a promising endoscopic approach in large BPH cases, characterized by good surgical efficiency and similar BPH tissue removal capabilities compared with standard transvesical prostatectomy. BPEP patients benefited from significantly reduced complications, shorter convalescence and satisfactory follow-up symptom scores and voiding parameters.
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Randomized Controlled Trial Multicenter Study Comparative Study
Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE).
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Antimuscarinics are effective and well tolerated for treatment of OAB. Studies have found that a flexible dosing strategy can be effective in improving OAB symptoms with minimal impact on tolerability. This study confirms these findings with two doses of solifenacin, and shows that improved outcomes can be achieved by increasing solifenacin dose (from 5 to 10 mg) in patients with more severe symptoms. ⋯ Increasing the solifenacin dose to 10 mg further improved OAB symptoms in patients who requested a dose increase after 8 weeks' treatment with 5 mg solifenacin. The present study supports the view that patients with severe OAB symptoms benefit from a higher antimuscarinic dose.
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Multicenter Study
Prostate-specific antigen (PSA) concentrations in hypogonadal men during 6 years of transdermal testosterone treatment.
WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Hypogonadism affects an estimated 2-4 million men in the USA, but only 5% receive treatment. Testosterone replacement therapy reduces the effects of testosterone deficiency on sexual function, mood and energy in hypogonadal patients. Long-term hypogonadism management requires testosterone treatment to restore serum concentrations of testosterone and its active metabolites, within physiological ranges; a testosterone preparation that achieves physiological plasma concentrations without supra-physiological escape is a preferred option. A previous 1-year study European clinical study showed the efficacy and safety of a transdermal testosterone patch (Testopatch(®) ). The present study shows the long-term (6-year) safety and efficacy of Testopatch in patients with primary or secondary hypogonadism. We show that, over the long-term, Testopatch was associated with no relevant changes in PSA concentration and PSA velocity, or any significant prostate risks (there were no cases of prostate cancer). ⋯ These data support a strong safety profile for Testopatch, even at the highest registered dosage.
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WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Active surveillance has been widely accepted as a treatment tool for low-risk prostate cancer, and use of the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria can select smaller and less aggressive tumours in low-risk disease. The study shows the pathological outcomes of radical prostatectomy for patients with low-risk disease who met the PRIAS criteria. It found that ~20% had unfavourable pathological features and only 30% satisfied insignificant cancer criteria with pT2 stage, a Gleason score ≤6 and tumour volume <2.5 mL. It concludes that close follow-up including repeat biopsy or MRI is necessary to minimize unexpected progression of disease. ⋯ Although use of the PRIAS criteria could select more favourable tumours even in low-risk prostate cancer, about one in five men had unfavourable pathological outcomes and only three in ten had insignificant cancer. Close and careful follow-up is necessary to avoid misclassification or progression of disease, especially during the first few years of active surveillance.