Haglind E., Carlsson S., Stranne J., Wallerstedt A., Wilderäng U., Thorsteinsdottir T., Lagerkvist M., Damber J.-E., Bjartell A., Hugosson J., Wiklund P., Steineck G.
European Urology 2015 68:2 (216-225)
Background Robot-assisted laparoscopic radical prostatectomy (RALP) has become widely used without high-grade evidence of superiority regarding long-term clinical outcomes compared with open retropubic radical prostatectomy (RRP), the gold standard. Objective To compare patient-reported urinary incontinence and erectile dysfunction 12 mo after RALP or RRP. Design, setting, and participants This was a prospective, controlled, nonrandomised trial of patients undergoing prostatectomy in 14 centres using RALP or RRP. Clinical-record forms and validated patient questionnaires at baseline and 12 mo after surgery were collected. Outcome measurements and statistical analyses Odds ratios (ORs) were calculated with logistic regression and adjusted for possible confounders. The primary end point was urinary incontinence (change of pad less than once in 24 h vs one time or more per 24 h) at 12 mo. Secondary end points were erectile dysfunction at 12 mo and positive surgical margins. Results and limitations Of 2625 eligible men, 2431 (93%) could be evaluated for the primary end point. At 12 mo after RALP, 366 men (21.3%) were incontinent, as were 144 (20.2%) after RRP. The adjusted OR was 1.08 (95% confidence interval [CI], 0.87-1.34). Erectile dysfunction was observed in 1200 men (70.4%) 12 mo after RALP and 531 (74.7%) after RRP. The adjusted OR was 0.81 (95% CI, 0.66-0.98). The frequency of positive surgical margins did not differ significantly between groups: 21.8% in the RALP group and 20.9% in the RRP group (adjusted OR: 1.09; 95% CI, 0.87-1.35). The nonrandomised design is a limitation. Conclusions In a Swedish setting, RALP for prostate cancer was modestly beneficial in preserving erectile function compared with RRP, without a statistically significant difference regarding urinary incontinence or surgical margins. Patient summary We compared patient-reported urinary incontinence after prostatectomy with two types of surgical technique. There was no statistically significant improvement in the rate of urinary leakage, but there was a small improvement regarding erectile function after robot-assisted operation.