A European Multicenter Randomized Noninferiority Trial Comparing 180 W GreenLight-XPS Laser Vaporization and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: 12-Month Results of the GOLIATH Study
| Autor: | Richard Hindley, Antony C. P. Riddick, Nirjan-Kumar Gogoi, Gordon Muir, Tim Larner, Martin Schostak, Frank C H d'Ancona, Marc-Oliver Grimm, Kurt Miller, Helmut H. Knispel, Herman Roelink, Sascha Pahernik, Ulrich Witzsch, Wolfgang Loidl, Joan Benejam, Moritz Hamann, Jens-Uwe Stolzenburg, Neil Barber, Andrew C. Thorpe, Rolf Muschter, Christian Saussine, Alexander Bachmann, Nitin Shrotri, Andrea Tubaro, Stuart L. Graham, Filip Ameye, J. Andrew Thomas, Franck Bruyère, Carlos Capitán |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Time Factors SF-36 Urology medicine.medical_treatment Prostatic Hyperplasia Urinary incontinence overactive bladder green light law.invention Lower Urinary Tract Symptoms Randomized controlled trial law Lower urinary tract symptoms medicine Humans Prospective Studies Transurethral resection of the prostate green light business.industry Transurethral Resection of Prostate medicine.disease Urinary Bladder Neck Obstruction Prostate-specific antigen Treatment Outcome Overactive bladder International Prostate Symptom Score overactive bladder medicine.symptom business |
| Popis: | We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments.A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup.Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence.Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups. |
| Databáze: | OpenAIRE |
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