Functional outcomes of hypothermic robot assisted radical prostatectomy using BELLOCOOL in a randomized controlled trial
Abstract
Hypothermia during robot-assisted radical prostatectomy (RARP) has been proposed to enhance functional recovery. This study aimed to assess the efficacy of BELLOCOOL-induced hypothermic RARP for improving urinary continence and erectile function. A total of 200 patients with cT1-T3aN0M0 prostate cancer, eligible for bilateral nerve-sparing surgery, were enrolled across three tertiary centers and randomized 1:1. Stratification was based on International Index of Erectile Function (IIEF-5) scores (≥ 12). The primary endpoint was continence status at 6 months, defined by the use of < 1 pad versus ≥ 1 pads daily. Secondary endpoints included continence and erectile function recovery and safety assessment using the Clavien system. The primary outcome showed no significant difference between groups. However, among patients with IIEF-5 ≥ 12, those in the hypothermic group exhibited significantly better erectile function recovery than normothermic group at 12 months, with higher IIEF-5 score (9.29 ± 7.25 vs. 6.33 ± 5.16, p = 0.02). In a hypothesis-generating post hoc analysis, non-diabetic patients with baseline IIEF-5 ≥ 12 had a significantly higher erectile function recovery (81% vs. 70%, p = 0.04) and continence recovery rates (89% vs. 67%, p = 0.02) in the hypothermic group, findings that warrant cautious interpretation.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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