Department of Urology and Renal Transplantation, Vall d'Hebron Hospital, Barcelona, Spain.
Department of Urology and Renal Transplantation, Vall d'Hebron Hospital, Barcelona, Spain; Prostate Cancer Research Group, Vall d'Hebron Research Institute, Barcelona, Spain.
Eur Urol Oncol. 2022 Aug;5(4):460-463. doi: 10.1016/j.euo.2021.02.005. Epub 2021 Feb 27.
Posterior rhabdosphincter reconstruction (PRR) has been proposed to improve early urinary continence (UC) recovery after radical prostatectomy (RP). In order to generate level 1b evidence, we designed a double-blind randomised controlled trial powered to detect a 20% increase in early UC recovery after robot-assisted RP (RARP). A group of 153 patients with cT1c-3a N0M0 prostate cancer were randomised (73 to control arm and 80 to PRR arm) and 152 completed 12-mo follow-up. For UC defined as no pad use, the recovery hazard ratio at 1-mo follow-up was 2.312 (95% confidence interval [CI] 1.081-4.937; p = 0.030). UC recovery was observed in 33.8% of patients in the PRR arm and 18.1% of patients in the control arm (p = 0.022). At 3-mo follow-up the corresponding rates were 58.8% and 43.1% (p = 0.038). The median time to UC recovery was 106 d (95% CI 73-139) in the control arm and 64 d (95% CI 39-89) in PRR arm (p = 0.897). No differences in pathological outcomes or early and late surgical complications were observed between the arms. We conclude that PRR is safe and increases early UC recovery after RARP. PATIENT SUMMARY: We investigated reconstruction of a muscular ring that controls the flow of urine, called the rhabdosphincter, after removal of the prostate in robot-assisted surgery. The procedure is safe and increases early recovery of urinary continence. This trial is registered at ClinicalTrials.gov as NCT03302169.
后阴部横纹肌重建术（PRR）已被提出用于改善根治性前列腺切除术（RP）后早期尿控（UC）的恢复。为了产生 1b 级证据，我们设计了一项双盲随机对照试验，旨在检测机器人辅助 RP（RARP）后早期 UC 恢复增加 20%。一组 153 例 cT1c-3a N0M0 前列腺癌患者被随机分组（73 例入对照组，80 例入 PRR 组），152 例完成 12 个月随访。对于定义为不使用尿垫的 UC，1 个月随访时的 UC 恢复风险比为 2.312（95%置信区间 [CI] 1.081-4.937；p=0.030）。PRR 组中有 33.8%的患者和对照组中有 18.1%的患者（p=0.022）恢复 UC。3 个月随访时，相应的比率分别为 58.8%和 43.1%（p=0.038）。对照组 UC 恢复的中位时间为 106 d（95%CI 73-139），PRR 组为 64 d（95%CI 39-89）（p=0.897）。两组在病理结果或早期和晚期手术并发症方面无差异。我们得出结论，PRR 是安全的，并增加了 RARP 后早期 UC 的恢复。患者总结：我们研究了在机器人辅助手术中切除前列腺后重建控制尿液流动的肌肉环（称为阴部横纹肌）的方法。该手术是安全的，并且可以增加早期尿控的恢复。这项试验在 ClinicalTrials.gov 注册为 NCT03302169。
