Abstract
Background and Purpose:
This is the third publication that updates clinical outcomes using a novel technique to apply locoregional hypothermia to the pelvis during robot-assisted radical prostatectomy (RARP) to reduce inflammatory injury. This report updates urinary and sexual clinical outcomes with a minimum of 1 year follow-up.
Patients and Methods:
Regional pelvic cooling (<30°C) was achieved with a prototype endorectal cooling balloon (ECB) during the course of RARP. All clinical data were entered prospectively into an electronic database for historic (cases 1–666) and hypothermic groups (115 pts). Urinary and sexual outcomes were obtained using self-administered validated questionnaires. Continence was defined as no pads, and potency was defined as two affirmative answers to “erections adequate for penetration” and “were the erections satisfactory.”
Results:
Six patients were excluded: three ECB malfunction, three previous radiation/surgery. Median time to zero pad use was 39 days vs 62 days (hypothermic vs controls, P = 0.0003). At 1 year, overall pad-free continence was 96.3% (105/109) vs controls of 86.6%, P < 0.001. Potency was evaluated in all men (40–78 years) with preoperative International Index of Erectile Function-5 scores of 22 to 25. At 3 months, potency results were unchanged between groups: 24% vs 23%. At 15 months, the potency rates were significantly better for the hypothermic group, 83% vs controls 66%, P = 0.045. No difference in oncologic outcome was noted with cooling.
Conclusions:
Using a prototype cooling balloon, hypothermic RARP significantly improved time to continence and overall continence. Hypothermia also resulted in a modest but statistically significant improvement in potency at 15 months. Once cooling parameters have been optimized, a randomized multicenter clinical trial will be needed for validation.
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