Institute of Urologic Oncology, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California, USA.
J Endourol. 2010 Jul;24(7):1111-6. doi: 10.1089/end.2010.0122.
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.
Regional pelvic cooling (<30 degrees C) [corrected] was achieved with a prototype endorectal cooling balloon (ECB) during the course ofRARP. 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."
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.
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.
这是第三篇使用新方法在机器人辅助根治性前列腺切除术（RARP）期间应用局部低温来减少炎症损伤的临床结果更新。本报告更新了至少 1 年随访的尿和性功能临床结果。
在 RARP 过程中，使用原型直肠内冷却球囊（ECB）实现局部骨盆冷却（<30°C）。所有临床数据均前瞻性地输入电子数据库，用于历史（病例 1-666）和低温组（115 例）。使用自我管理的经过验证的问卷获得尿和性功能结果。尿控定义为无尿垫，勃起功能定义为“勃起足以插入”和“勃起满意”两个肯定答案。
有 6 例患者被排除：3 例 ECB 故障，3 例先前接受过放疗/手术。无尿垫使用的中位时间为 39 天与 62 天（低温组与对照组相比，P=0.0003）。在 1 年时，整体无尿垫尿控率为 96.3%（105/109）与对照组的 86.6%相比，P<0.001。所有接受术前国际勃起功能指数-5 评分 22 至 25 分的 40-78 岁男性均进行了勃起功能评估。在 3 个月时，两组之间勃起功能无明显变化：24%比 23%。在 15 个月时，低温组的勃起功能明显更好，83%比对照组的 66%，P=0.045。低温对肿瘤学结果无影响。
使用原型冷却球囊，低温 RARP 显著改善了尿控时间和整体尿控率。低温还导致 15 个月时勃起功能略有但统计学上显著改善。一旦优化了冷却参数，将需要进行随机多中心临床试验进行验证。
