Krhut Jan, Bartáková Lucie, Kondé Adéla, Sýkora Radek Paus, Rychlý Tomáš, Zachoval Roman
Department of Urology, University Hospital, Ostrava, Czech Republic.
Department of Surgical Studies, Ostrava University, Ostrava, Czech Republic.
BJU Int. 2025 Jan;135(1):103-109. doi: 10.1111/bju.16511. Epub 2024 Aug 26.
To report the clinical outcomes of the Victo™ (Promedon, Cordoba, Argentina) adjustable artificial urinary sphincter (AUS) implantation in a cohort of patients with severe urinary incontinence (UI) after prostate surgery.
This study enrolled patients with UI following prostate surgery who underwent a Victo implantation between May 2018 and December 2023. Patients were prospectively evaluated at baseline, and at 3 and 12 months after device activation, and thereafter annually. The 24-h pad-weight test (24hPWT) was used to assess severity of UI, while the Patient Global Impression of Improvement (PGI-I) and patient satisfaction according to a Likert scale were used to measure patient-reported outcomes.
A total of 96 patients with a median (interquartile range [IQR]) age of 68 (65-72) years were included in the final analysis. The median (IQR) follow-up was 3 (1-4) years. In all, 10 patients completed the 5-year follow-up. After the treatment, we observed a significant reduction in 24hPWT by the median of 83% (P < 0.001) at 3 months and by a median of 79% (P < 0.001) at 3 years. According to the PGI-I, a total of 87%, 92%, 87%, 81%, 83%, and 50% (five of 10) of patients rated their condition/incontinence as 'very much improved', 'much improved' or 'little improved' at 3 months, 1-, 2-, 3-, 4-, and 5-year follow-up visits, respectively. The proportion of patients, who were 'very satisfied' or 'satisfied' with the treatment outcome was 79%, 80%, 75%, 69%, 80%, and 60% (six of 10) at 3 months, 1-, 2-, 3-, 4-, and 5-years, respectively. There were a total of 13 (14%) device failures during the follow-up period.
In conclusion, our data suggest that Victo AUS significantly reduces the severity of UI after prostate surgery and provides a reasonably high patient-reported satisfaction with treatment outcomes at mid-term follow-up.
报告Victo™（阿根廷科尔多瓦市的Promedon公司生产）可调节人工尿道括约肌（AUS）植入术在一组前列腺手术后严重尿失禁（UI）患者中的临床疗效。
本研究纳入了2018年5月至2023年12月期间接受Victo植入术的前列腺手术后尿失禁患者。对患者在基线、装置激活后3个月和12个月以及此后每年进行前瞻性评估。采用24小时尿垫重量试验（24hPWT）评估尿失禁的严重程度，同时使用患者总体改善印象（PGI-I）和基于李克特量表的患者满意度来衡量患者报告的结局。
最终分析纳入了96例患者，年龄中位数（四分位间距[IQR]）为68（65 - 72）岁。随访时间中位数（IQR）为3（1 - 4）年。共有10例患者完成了5年随访。治疗后，我们观察到在3个月时24hPWT中位数显著降低83%（P < 0.001），在3年时中位数降低79%（P < 0.001）。根据PGI-I，在3个月、1年、2年、3年、4年和5年随访时，分别有87%、92%、87%、81%、83%和50%（10例中的5例）的患者将其病情/尿失禁评为“非常改善”“改善很多”或“改善一点”。对治疗结果“非常满意”或“满意”的患者比例在3个月、1年、2年、3年、4年和5年时分别为79%、80%、75%、69%、80%和60%（10例中的6例）。随访期间共有13例（14%）装置故障。
总之，我们的数据表明Victo AUS显著降低了前列腺手术后尿失禁的严重程度，并在中期随访时为患者报告的治疗结果提供了相当高的满意度。
