A Randomized Control Trial Of Anti-Inflammatory Regional Hypothermia On Urinary Continence During Robot-Assisted Radical Prostatectomy

Abstract

The present study seeks to present a single-blind, randomized control trial of a hypothermic anti-inflammatory device, the endorectal cooling balloon (ECB), to assess whether regional hypothermia could improve 90-day and time to pad-free continence following robot-assisted radical prostatectomy (RARP). Five high-volume surgeons at three institutions had patients randomized (1:1) to regional hypothermia with ECB versus control. Patients were blinded to device use, as it was inserted and removed intraoperatively. Knowledge of device use was restricted to the operating room personnel only; recovery room and ward nursing staff were not informed of device use and instructed to indicate such if a patient inquired. An independent and blinded data acquisition contractor assessed outcomes via components of the EPIC and IPSS. The primary outcome was categorical pad-free continence at 90-days and the secondary outcome was a Kaplan-Meier time-to pad-free continence at 90 days. 100 hypothermia and 99 control patients were included. The primary outcome of 90-day pad-free continence was 50.0% (27.8–70.0%) in the hypothermia group versus 59.2% (33.3–78.6%) in the control (p = 0.194). The secondary outcome of Kaplan Meier analysis for time to 90-day continence was not statistically significant. At one year, there were also no statistically significant differences in continence recovery. Post-hoc analysis revealed a trend towards improvement in continence in one of three sites. Overall, the trial demonstrated no benefit to regional hypothermia either in our primary or secondary outcomes. It is suggested that surgical technique and prevention of surgical trauma may be more advantageous to improving continence recovery.

Surgeon heterogeneity significantly affects functional and oncological outcomes after radical prostatectomy in the Swedish LAPPRO trial

“…A Swedish population‐based study looking at the effects of surgeon’s ( n = 9) variability on oncological and functional outcomes, also reported large heterogeneity in continence rate after RRP, but not for ED or recurrence rate [16]. In 2018, Huynh et al [24] showed a 10‐fold variation in 3‐month continence rate when comparing five surgeons. Surgeon volume as an important factor for outcomes after RP was first described by Begg et al [23] and has been commented on in follow‐up papers [25] and in subsequent studies on learning curve [21,26–29].…”

“…While heterogeneity in functional and oncological outcomes has been described earlier [15][16][17][22][23][24], underlying factors explaining such heterogeneity have not been reported in detail for RALP or RRP. In 2010, Bianco et al [17] described variations among experienced surgeons in cancer control after RRP in a study from four high-volume centres.…”

Systematic review on urinary continence rates after robot-assisted laparoscopic radical prostatectomy

“…, the authors investigated the effect of regional hypothermia during RALP on urinary continence rates. In their RCT, they compared two parallel groups, finding no benefit in the 3-month continence rates in the regional hypothermia group reporting post-RALP continence of 50% and 59.6% in the regional hypothermia ( n = 100) and control groups ( n = 99) respectively ( p = 0.1748) [ 23 ]. Antonelli et al .…”

“…In a unique study by Hyunh et al . , regional hypothermia was trialled as part of the RALP operation via an endorectal cooling balloon, but the technique failed to demonstrate any benefit in return urinary continence [ 23 ]. Delayed versus standard ligation of the dorsal venous complex was studied by Antonelli et al .…”

A single-center, retrospective review of robot-assisted laparoscopic prostatectomy with and without cryopreserved umbilical cord allograft in improving continence recovery

“…Other attempts have been made to reduce post-surgical inflammation after RARP. Some studies evaluated the induction of regional hypothermia via an endorectal cooling balloon; however, a recent randomized control trial demonstrated no significant benefit for continence recovery [58]. In addition, other studies have assessed the use of dehydrated AM tissue around the NVB in accelerating return to potency; however, only one study has reported continence outcomes [41].…”