A multicenter randomized noninferiority trial comparing greenlight-XPS laser vaporization of the prostate and transurethral resection of the prostate for the treatment of benign prostatic obstruction. two-yr outcomes of the GOLIATH study
| Autor: | Wolfgang Loidl, Tim Larner, Ulrich Witzsch, Andrea Tubaro, Neil Barber, Martin Schostak, Andrew C. Thorpe, Herman Roelink, Jens-Uwe Stolzenburg, Nirjan-Kumar Gogoi, Moritz Hamann, Stuart L. Graham, Filip Ameye, Richard Hindley, Antony C. P. Riddick, Alexander Bachmann, Nitin Shrotri, Gordon Muir, Frank C H d'Ancona, Helmut H. Knispel, Kurt Miller, Rolf Muschter, Christian Saussine, Franck Bruyère, Carlos Capitán, Marc-Oliver Grimm, Sascha Pahernik, James Andrew Thomas, Joan Benejam |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Urology 030232 urology & nephrology Prostatic Hyperplasia International Prostate Symptom Scores Lasers Solid-State Photoselective vaporization of the prostate Quality of Life urologic and male genital diseases Severity of Illness Index law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Lower urinary tract symptoms Prostate law Surveys and Questionnaires medicine Humans Prospective Studies Transurethral resection of the prostate Benign prostatic hyperplasia Benign prostate obstruction Transurethral resection of prostate business.industry Lasers Solid-State Organ Size Prostate-Specific Antigen medicine.disease Prostate-specific antigen medicine.anatomical_structure Treatment Outcome Urinary Incontinence The Overactive Bladder Questionnaire Short Form Overactive bladder Patient Satisfaction 030220 oncology & carcinogenesis Quality of Life GL-XPS International Prostate Symptom Score Follow-Up Studies Transurethral Resection of Prostate business |
| Popis: | Background The GOLIATH study is a 2-yr trial comparing transurethral resection of prostate (TURP) to photoselective vaporization with the GreenLight XPS Laser System (GL-XPS) for the treatment of benign prostatic obstruction (BPO). Noninferiority of GL-XPS to TURP was demonstrated based on a 6-mo follow-up from the study. Objective To determine whether treatment effects observed at 6 mo between GL-XPS and TURP was maintained at the 2-yr follow-up. Design, setting, and participants Prospective randomized controlled trial at 29 centers in nine European countries involving 281 patients with BPO. Intervention Photoselective vaporization using the 180-W GreenLight GL-XPS or conventional (monopolar or bipolar) TURP. Outcome measurements and statistical analysis The primary outcome was the International Prostate Symptom Score for which a margin of three was used to evaluate the noninferiority of GL-XPS. Secondary outcomes included Q max , prostate volume, prostate specific antigen, Overactive Bladder Questionnaire Short Form, International Consultation on Incontinence Questionnaire Short Form, occurrence of surgical retreatment, and freedom from complications. Results and limitations One hundred and thirty-six patients were treated using GL-XPS and 133 using TURP. Noninferiority of GL-XPS on International Prostate Symptom Score, Q max , and freedom from complications was demonstrated at 6-mo and was sustained at 2-yr. The proportion of patients complication-free through 24-mo was 83.6% GL-XPS versus 78.9% TURP. Reductions in prostate volume and prostate specific antigen were similar in both arms and sustained over the course of the trial. Compared with the 1 st yr of the study, very few adverse events or retreatments were reported in either arm. Treatment differences in the Overactive Bladder Questionnaire Short Form observed at 12-mo were not statistically significant at 24-mo. A limitation was that patients and treating physicians were not blinded to the therapy. Conclusions Twenty-four-mo follow-up data demonstrated that GL-XPS provides a durable surgical option for the treatment of BPO that exhibits efficacy and safety outcomes similar to TURP. Patient summary The long-term effectiveness and safety of GLP-XLS was similar to conventional TURP for the treatment of prostate enlargement. |
| Databáze: | OpenAIRE |
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