PD32-12 REFILLABLE ARTIFICIAL URINARY SPHINCTER ZSI 375 PF: SPANISH MULTICENTRE EXPERIENCE

Abstract

INTRODUCTION AND OBJECTIVES: Objective: to report the experience in 4 tertiary hospitals with the pre-connected, pre-filled and refillable artificial urinary sphincter (AUS) ZSI 375 PF (Zephyr Surgical Implants, Geneva, CH). METHOD(S): Retrospective, nonrandomised, multicentre study. From December 2015 to June 2018, 28 male patients (PTS) underwent device implantation. SUCCESS RATE DEFINITIONS: dry ( =2 pads/day), failed. Data collection of clinical chart and clinical interview and exploration of the PTS was performed and introduced inan Excel calculation worksheet. Statistical analysis was done through G-stat 2.0. RESULT(S): Median age: 72 years (range 56-83). Initial surgery: 14 open radical prostatectomies (RP) (50%), 8 laparoscopic RP (28.6%), 3 robot-assisted RP (10.7%), 2 transurethral resection of the prostate (7.1%). 1 open adenomectomy (3.6%). External radiation therapy (ERT) was performed in 16 PTS (and HIFU in one patient). Previous anti-UI surgeries: 3 AMS-800TM, 2VirtueTM, 2 botulinum toxin and 1 UrolasticTM; 1 patient had first an AdvanceTM and a Flow- SecureTM after. Previous cervicotomy in 10 PTS (twice in one patient). Prior history of recurrent urinary tract infections (RUTI) in 4 PTS. MEDIAN PAD TEST: 1200 g. Urodynamic study: UI 100%, overactive bladder 17.4%, detrusor underactivity during voiding 10.7%. No intraoperative complications. HOSPITAL STAY: 1-3 days. The device was activated 50 days after surgery on average. Refill was performed in 12 PTS (1-3 times each), median volume 0.4 ml. Nine of these PTS have received ERT (including the patient after HIFU, 75%). CONTINENCE RATE: 19 PTS dry (67.9%), 7 PTS improved (25%), 2 PTS failed (AUS explantation) (7.1%). Seven PTS with persistent urinary incontinence had prior ERT (p=0.1359) and 3 had prior anti-UI surgeries (p=0.4834). COMPLICATIONS: Erosion with explantation in 2 PTS with prior RUTI and cervicotomy (Clavien-Dindo IIIb) (7.1%); one patient had prior ERT. Postoperative hydrocele in 1 patient, managed conservatively (Clavien-Dindo I) (3.6%). Another patient required catheterization 48 hours after hospital discharge and cuff opening required surgical exploration (Clavien-Dindo IIIa) (3.6%). CONCLUSION(S): The refillable AUS ZSI 375 PF is a reliable alternative with good continence results and low complication rate. Although previous ERT might influence the achievement of complete continence after implantation, it is not an absolute contraindication. Careful information should be given to PTS with previous RUTI since they seem to have a higher risk for device infection and explantation.