Barbagli Guido, Rimondi Claudio, Balò Sofia, Butnaru Denis, Sansalone Salvatore, Lazzeri Massimo
Centro Chirurgico Toscano, Arezzo, Italy.
Research Institute of Uronephrology, Sechenov First Moscow State Medical University, Moscow, Russia.
Urology. 2017 Sep;107:246-250. doi: 10.1016/j.urology.2017.04.039. Epub 2017 May 26.
To evaluate the efficacy of the Memokath stent in managing recurrent bulbar urethral strictures.
This is an investigative pilot stage 2A study in patients with a recurrent bulbar urethral stricture who underwent a Memokath stent implant from January 2014 to January 2016 in a single high-volume center for urethral reconstruction. The Memokath stent (Pnn Medical A/S, Kvistgaard, Denmark) was manufactured from nitinol, a biocompatible alloy of nickel and titanium, which was endoscopically placed. It had a 24-Fr outside diameter and was preloaded on a disposable delivery device. When correctly positioned, the stent was anchored by a warm water (55°C) instillation, which expanded the proximal end of the stent from 24 to 42 Fr .The stent was provided in lengths of 3-7 cm in 1-cm increments.
Sixteen patients were included in the study. The median follow-up was 16 months. In 7 patients (43.7%), the stent was removed within 1 year. The main adverse events were pain, encrustations, stones, and recurrent strictures. Four patients (25%) were considered a success and 12 (75%) were failures. Study limitations include the small sample.
The Memokath stent was deemed to be not clinically helpful and had significant side effects, and therefore should not be considered a treatment option for men with bulbar urethral strictures.
评估Memokath支架治疗复发性球部尿道狭窄的疗效。
这是一项探索性的2A期研究，研究对象为2014年1月至2016年1月期间在一家大型尿道重建中心接受Memokath支架植入术的复发性球部尿道狭窄患者。Memokath支架（丹麦Kvistgaard的Pnn Medical A/S公司生产）由镍钛诺制成，镍钛诺是一种镍和钛的生物相容性合金，通过内镜放置。其外径为24F，预装在一次性输送装置上。正确定位后，通过注入温水（55°C）使支架近端从24F扩张至42F，从而固定支架。支架长度有3 - 7厘米，以1厘米为增量。
16名患者纳入研究。中位随访时间为16个月。7名患者（43.7%）在1年内取出了支架。主要不良事件包括疼痛、结痂、结石和复发性狭窄。4名患者（25%）治疗成功，12名患者（75%）治疗失败。研究局限性包括样本量小。
Memokath支架被认为在临床上并无帮助，且有显著副作用，因此不应被视为球部尿道狭窄男性患者的治疗选择。
