ClearRing is a permanent, open ring-shaped nitinol implant with the objective of reshaping the prostatic urethra. The ring is placed in the prostatic urethra with a 24F delivery system composed of a tip with a balloon dilator over which a cutting cautery blade creates the space where the implant is placed. The device is inserted transurethrally and the balloon is inflated to expand the obstruction in the prostatic urethra and then a small electrode on the outside of the balloon creates a circumferential incision in the tissue around the prostatic urethra through which the implant will be inserted, and this way the implant is not in direct contact with the urine.
The patient is discharged with a catheter for 24–48 h.
Feld et al. in a multicenter single-arm clinical trial involving 29 cases, mean prostate size of 35–50 cm reported mean improvements in IPSS, QoL, and Qmax by 45%, 41%, and 40% at 3 mo, and 53%, 52%, and 49% at 12 mo, respectively (P < 0.05). No loss of antegrade ejaculation or erectile disfunction was observed.
All procedures were done under spinal anesthesia. No serious complications occurred. The most common adverse events were transient hematuria (100%), dysuria (6%) and urgency (6%). Implantation failed in 38% of the cases because of implant malpositioning and all required a TURP.
Curr Opin Urol. 2021;31(5):461-467. © 2021 Wolters Kluwer Health, Inc.