New findings from the first prospective, multicenter, randomized trial demonstrated improved continence for patients undergoing robotic-assisted radical prostatectomy as compared with conventional laparoscopic radical prostatectomy.
Prof. Jens-Uwe Stolzenburg (University of Leipzig, Germany) presented the results of the LAP-01 study, which aimed to generate conclusive data supporting improved continence after robotic-assisted radical prostatectomy (R-LRPE) in a prospective setting in four German centers1.
Patients (at data cut-off, n=713) were randomized 3:1 to either robotic-assisted (n=527) or conventional laparoscopic radical prostatectomy (LRPE; n=186). Patients were blinded to their arm allocation until month 3. The primary endpoint of the study was continence restoration at month 3, as defined by not requiring a pad for 3 or more consecutive days. Post-operative follow-up will be continued for 3 years, with assessments planned for 1, 3, 6, 12, 24, and 36 months. Prof. Stolzenburg presented the data for up to 12 months.
Overall, complication rates were lower in patients who received robotic surgery. Perioperative outcomes were comparable between both arms, including nerve-sparing rates, prostate size/weight, margin status, pathological tumor stage, duration of surgery, and duration of catheterization. However, the primary endpoint was met and continence rates among the patients treated robotically were significantly higher at 3 months (P=0.00064), 6 months (P=0.004), and 12 months (P=0.044). Continued follow-up will determine the longer-term effects.
1. Stolzenburg J-U, et al. Continence Following Robot-Assisted (R-LRPE) and Conventional Laparoscopic Radical Prostatectomy (LRPE) – Results of a Prospective, Randomized, Multicenter, Patient Blinded Study. EAU20 Virtual Congress, 17-26 July 2020, Game-Changing Session 1.