Characterization of a novel implant intended to expand and reshape the prostatic urethra for the treatment of benign prostatic hyperplasia: A pre- clinical feasibility study in the canine model
Urology Nov 04, 2021
Chughtai B, Punyala A, Lata SS, et al. - A novel device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia was put to test using the first-generation XFLO Expander System (Mercury Expander System), and a favorable safety profile in the canine model was shown by the XFLO Expander System. Prostatic urethra shape was successfully altered, with increased urethral width evident during the dwell period with minimal tissue changes.
In 8 adult male canines, the implant was deployed and retrieved via flexible cystoscope.
An increase in urethral width was achieved (6.9±1.8 mm to 10.2±0.6 mm) which remained preserved through the dwell period.
All participants (n=8) remained continent without obstruction or retention, and incisional site bleeding (n=2) and transient hematuria (n=3) occurred (adverse events).
The implant did not show any encrustation, tissue growth or stone formation.
Glandular acinar changes, inflammation, and fibrosis were seen in histopathology.
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