Complete bladder neck preservation promotes long-term post-prostatectomy continence without compromising midterm oncological outcome: analysis of a randomised controlled cohort.

Purpose: The only RCT available on complete bladder neck preservation (cBNP) during radical prostatectomy reported superior continence and QoL outcomes in the first 12 months after cBNP. We provide the first data on long-term urinary continence, QoL and biochemical recurrence (BCR) after complete bladder neck preservation in a randomised controlled cohort.

Methods: After approval by IRB, 199 men recruited for the randomised, controlled single-blind Heidelberger cBNP Study had prostatectomy performed with (cBNP) or without (noBNP) complete bladder neck preservation. Only men with renewed consent for this follow-up were evaluated for continence, QoL outcomes and BCR by ICIQ-SF self-assessment questionnaire, Pad-use/day and PSA levels. Students-t test, Pearson´s Chi-square, Fishers exact test and multiple logistic regression analyses were applied.

Results: Mean follow-up was approx. 4 years. There were no significant differences in baseline characteristics between responders/non-responders or between study groups. We noted significantly higher continence rates (p = 0.004), less pad-use (p < 0.001), reduced frequency (p = 0.023) and amount (p = 0.009) of urine loss, and higher QoL outcomes (p = 0.012) after cBNP. A younger age positively influenced continence (OR = 0.91), but the multivariate analysis found cBNP to be the only independent predictor of continence (p = 0.008; OR = 8.1). pT stage was the only predictor for positive surgical margins (PSM; p < 0.001). There was no significant difference in pT stage (p = 0.23) or BCR (p = 0.63) between study groups and also no significant correlation between BCR and presence (p = 0.26) or localisation (p = 0.11) of PSM, nerve sparing (p = 0.70), surgeon (p = 0.41), preoperative PSA (p = 0.53) or pT stage (p = 0.17). No cancer-related death was noted.

Conclusions: Results of this first follow-up on a prospective randomised controlled cohort demonstrate that cBNP is associated with significantly higher continence and QoL outcomes without compromising cancer control making cBNP a novel objective during radical prostatectomy.