New York Presbyterian Hospital-Weill Cornell, New York, NY.
New York Presbyterian Hospital-Weill Cornell, New York, NY.
Urology. 2022 Jan;159:167-175. doi: 10.1016/j.urology.2021.10.015. Epub 2021 Oct 30.
To evaluate the safety, feasibility, and tissue response of a novel device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia, using the first-generation Urocross Expander System (Mercury Expander System).
The implant was deployed and retrieved using flexible cystoscope in 8 adult male canines, separated into three study arms by retrieval date (1-, 6-, and 12- months post-deployment). Cystoscopy and urethrograms verified implant position/diameter; bladder neck and external sphincter function/changes; prostatic tissue response; and implant condition. One-month post-retrieval, the prostate and surrounding tissue was sectioned and evaluated by a veterinary pathologist.
All implants were successfully deployed in the prostatic urethra. Urethral width was increased (6.9 ± 1.8 mm to 10.2 ± 0.6 mm, P = .012) and preserved through the dwell period. Urethral length and sphincter diameters didn't significantly change. All subjects (n = 8) remained continent without obstruction or retention. Adverse events included incisional site bleeding (n = 2) and transient hematuria (n = 3). One implant migrated into the bladder and spontaneously repositioned into the prostatic urethra. Post-retrieval, explant surfaces demonstrated no tissue growth, encrustation or stone formation. Imaging revealed contact site erythema and indentation, but no stones, strictures, perforations, erosions, nor ulcerations. Histopathology revealed glandular acinar changes, inflammation, and fibrosis.
The first generation of the Urocross Expander System demonstrated a favorable safety profile in the canine model. Changes in the prostatic urethra shape were noted with an increase in urethral width during the dwell period with minimal tissue changes. Further, the implant didn't demonstrate any encrustation, tissue growth or stone formation.
评估第一代 Urocross 扩张系统（水星扩张系统）治疗良性前列腺增生引起的下尿路症状的安全性、可行性和组织反应。
在 8 只成年雄性犬中，使用柔性膀胱镜将植入物部署和取出，根据取出日期（植入后 1、6 和 12 个月）将犬分为三个研究组。膀胱镜和尿道造影术证实了植入物的位置/直径；膀胱颈部和外括约肌的功能/变化；前列腺组织反应；和植入物状况。取出后 1 个月，兽医病理学家对前列腺和周围组织进行切片和评估。
所有植入物均成功地部署在前列腺尿道内。尿道宽度增加（6.9±1.8mm 至 10.2±0.6mm，P=0.012），并在停留期间得到保留。尿道长度和括约肌直径没有显著变化。所有 8 只受试犬（n=8）均保持无尿失禁、无梗阻或无潴留。不良事件包括切口部位出血（n=2）和短暂血尿（n=3）。一个植入物迁移到膀胱中并自行重新定位到前列腺尿道。取出后，植入物表面无组织生长、结垢或结石形成。影像学显示接触部位红斑和凹陷，但无结石、狭窄、穿孔、侵蚀或溃疡。组织病理学显示腺泡变化、炎症和纤维化。
第一代 Urocross 扩张系统在犬模型中表现出良好的安全性。在停留期间，前列腺尿道形状发生变化，尿道宽度增加，同时组织变化最小。此外，植入物没有任何结垢、组织生长或结石形成。
