INTRODUCTION AND OBJECTIVE:
Posterior rhabdosphincter reconstruction (PRR) has been proposed to improve early urinary continence recovery after radical prostatectomy (RP). In order to generate type Ib evidence, we designed a randomised controlled trial to was to analyze continence recovery in patients undergoing robot-assisted RP (RARP) with or without PRR, according to different methods of continence assessment.
We conducted a double-blinded randomized clinical trial (NCT03302169) to detect a 20% difference of continence rate at 1 month. A group of 152 patients with cT1c-3a N0M0 prostate cancer were randomised (72 to control arm and 80 to PRR arm) and were followed for 12 months. The main continence definition applied was “no pad use” (complete recovery). The use of 0-1 pad was applied as a secondary definition of continence. Validated questionnaires (EPIC26, ICIQ-SF and IPSS) were applied at 1, 3, 6 and 12 months after catheter removal. Surgeons were notified of computer randomization (random.org) after prostate excision. Patients and data gatherers were blinded to treatment allocation.
Preoperative clinical and functional variables were equivalent between study arms. The recovery of complete urinary continence hazard ratio at one month was 2.312 (95%CI: 1.081- 28 4.937), p =0.030. Urinary functional recovery was observed in 33.8% of PRR arm patients and 18.1% of 29 those in the control arm, p =0.022. At three months, the rates were 58.8% 30 and 43.1% respectively, p=0.038. The median time to reach complete urinary continence was 106 days (95CI: 31 73-139) in the control arm and 64 days (95%CI: 39-89) in PRR arm, p =0.897. When analyzing the use of 0-1 pad, the time to continence in the PPR arm was 13 days (95%CI 9-17) and 16 days (95%CI: 10-22) in the control arm, p =0.649. Questionnaires did not detect differences in the urinary continence rates at 1, 6 and 12 months. No differences in pathological outcomes, early and late surgical complications were observed between both arms.
PRR is a safe surgical technique that increases early urinary continence recovery after RARP when strict continence definition is used. Not all urinary continence measurement methods were able to discriminate early recovery in patients that underwent PRR.
Source of Funding: