MP20-19 Bipolar Enucleation of the Prostate (BipolEP) versus Transurethral Resection of the Prostate: A Prospective Randomized Controlled Non-Inferiority Trial

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I (MP20)1 May 2024MP20-19 Bipolar Enucleation of the Prostate (BipolEP) versus Transurethral Resection of the Prostate: A Prospective Randomized Controlled Non-Inferiority Trial Maximilian Pallauf, Christian Ramesmayer, Michael Abenhardt, Maximilian Horetzky, Hubert Grießner, Lukas Oberhammer, Martin Drerup, Thomas R. W. Herrmann, Lukas Lusuardi, and Thomas Kunit Maximilian PallaufMaximilian Pallauf , Christian RamesmayerChristian Ramesmayer , Michael AbenhardtMichael Abenhardt , Maximilian HoretzkyMaximilian Horetzky , Hubert GrießnerHubert Grießner , Lukas OberhammerLukas Oberhammer , Martin DrerupMartin Drerup , Thomas R. W. HerrmannThomas R. W. Herrmann , Lukas LusuardiLukas Lusuardi , and Thomas KunitThomas Kunit View All Author Informationhttps://doi.org/10.1097/01.JU.0001008732.80104.31.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Endoscopic enucleation (EEP) is the preferred surgical technique for treating men with moderate-to-severe lower urinary tract symptoms (LUTS) and a large prostate (>80 mL) and an accepted alternative to transurethral resection (TURP) for mid-sized glands (30-80 mL). More recently, a treatment-specific electrode was developed to facilitate EEP using bipolar current (BipolEP). This prospective randomized controlled trial tests the non-inferiority of BipolEP compared with TURP for prostates sized 50-140 mL. METHODS: We prospectively included men scheduled for surgical treatment of LUTS due to benign prostatic enlargement. We included men with an international prostate symptom score (IPSS) of ≥15, an IPSS quality-of-life score (IPSS-QoL) ≥ 3, and a peak flow rate (Qmax) of<15 ml/sec. or the inability to void following urinary retention. We randomized patients 1:1 for TURP vs. BipolEP and followed them for 12 months postoperatively. The key primary endpoint was the non-inferiority of BipolEP compared with TURP in the 12-month IPSS. According to the study protocol, the predefined non-inferiority range was 3, and the estimated sample size per treatment arm was 31. The key secondary endpoint was the superiority of BipolEP compared with TURP in resected prostate tissue per surgery-minute. We recorded complications to compare the safety of the procedures. RESULTS: We included 81 men, 41 TURP, and 40 BipolEP. At enrollment, the median prostate size was 79 mL (95%CI 60-95), the median PSA was 5.1 ng/ml (95%CI 2.6-8.2), the median IPSS was 21 (95%CI 16.5-24), and the median Qmax was 7.6 ml/sec. (95%CI 6-10.7); baseline characteristics did not differ between the treatment arms. 67 men (TURP 34, BipolEP 33) completed the 12-month follow-up. The median IPSS was 5 (95%CI 3-7) in the TURP arm and 5 (95%CI 3-9) in the BipolEP arm. BipolEP was tested to be non-inferior (intention-to-treat and per-protocol analyses; p<0.05). BipolEP resected more prostate tissue per surgery-minute than TURP (median g/min. 0.5 95%CI 0.4-0.7 vs. 0.4 95%CI 0.3-0.6; p=0.04). At 12 months, we recorded at least one complication in 43% of the TURP arm and 61% of the BioplEP arm (p=0.1). 27% of TURP complications were major (Clavien Dindo ≥ IIIB), but only 1 (4.5%) in the BipolEP arm was (p=0.1). CONCLUSIONS: We confirmed the non-inferiority of BipolEP compared with TURP for improving LUTS, and we proved the efficiency and safety of BipolEP. Longer follow-up is needed to assess whether the increased tissue removal results in a more sustained improvement of symptoms. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e327 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Maximilian Pallauf More articles by this author Christian Ramesmayer More articles by this author Michael Abenhardt More articles by this author Maximilian Horetzky More articles by this author Hubert Grießner More articles by this author Lukas Oberhammer More articles by this author Martin Drerup More articles by this author Thomas R. W. Herrmann More articles by this author Lukas Lusuardi More articles by this author Thomas Kunit More articles by this author Expand All Advertisement PDF downloadLoading ...