A new Artificial Urinary Sphincter (VICTO) with conditional occlusion for stress incontinence: preliminary clinical results.

Weibl P1, Ameli G1, Hoelzel R1, Rutkowski M1, Huebner W A1

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 103
Open Discussion ePosters
Scientific Open Discussion ePoster Session 7
Wednesday 29th August 2018
12:30 - 12:35 (ePoster Station 4)
Exhibition Hall
Male Incontinence Stress Urinary Incontinence Surgery New Instrumentation
1. Department of Urology, Teaching Hospital, Landesklinikum Korneuburg, Korneuburg, Austria
Presenter
P

Peter Weibl

Links

Poster

Abstract

Hypothesis / aims of study
Revisions of the artificial urinary sphincters (AUS) are mostly as the result of urethral erosion and sub cuff atrophy.  In addition to general risk factors, this may be attributed to the high occlusion pressures. The aim of the study is to determine the safety and efficacy of a novel AUS.
Study design, materials and methods
VICTO is an adjustable device with an occluding cuff (OC), a pressure regulating balloon and a self-sealing port for pressure adjustment. VICTO plus has additionally a stress relief balloon (SRB) to transmit transient intraabdominal pressure changes to the OC.  The regulating pressure is adjustable in the range 0-100 cmH2O and can be altered at any time after implantation by the injection or removal of fluid. 
The VICTO (with or without stress balloon - PROMEDON AUSTRIA) is a artificial urinary sphincter - silicone rubber implant which consists of a pressure regulating balloon with/or without  stress relief balloon (for conditional occlusion).  Typical urethral cuff and a  control pump come as a one piece device ready to use. 
From Dec. 2016 to Feb. 2018 the device was implanted in 32 patients (VICTO n=13, VICTO plus n= 19) suffering from stress incontinence after prostate surgery (radical prostatectomy n=29; endoscopic transurethral resection of the prostate n=3). We included the data from 20 patients (VICTO n=9, VICTO plus n= 11) with a mean follow-up time of 8,1 months (range 4-14). We used a telephone questionnaire and/or clinical checks to collect postoperative data as daily pad use and satisfaction rate. Average age at time of implantation was 72.1 (  5.6) years. Postoperatively  patients underwent  between 1 to 5 (IQR=1, M=2) readjustment in order  to achieve the final result.
Results
In all 20 cases the device was easily implanted and there were no postoperative complications according to Clavien-Dindo. Pad use per day (p/d) improved from 5.3 ( 3.4) to 1.7( 0.8) p/d. 
Four of our patients (20%) had one or more prior incontinence operations, all of them had an improvement of at least 50% in p/d.  The p/d improvement in patients (n= 6) with a prior irradiation was 73,5%.
In total 10 (50%) patients were socially dry (max 1p/d) after implantation. 6 patients (30%) used 2 p/d and 4 (20%) 3 p/d. Continence improved 61,2% on average. Continence was rated as "excellent" or "good" by 11 patients (55%), 3 patients (15%) rated their continence level as "poor" although the improvement in p/d was over 50%. The satisfaction rate was 100% (n =20), 11 patients (55%) rated their overall satisfaction with the procedure as "excellent", 5 (25%) as "good" and 4 as "satisfactory".
Interpretation of results
This series represents the very first experience with the device. Continence results are promising,  however they may likely improve with growing experience. adjusting the system pressure to the lowest level providing continence may reduce the long term rate of erosions and subcuff atrophy, however such data are not yet available.
Concluding message
The device provides adjustability in regulating pressure in situ. Low initial pressure may reduce the need for surgical revision caused by urethral erosion and sub cuff atrophy. Continence rates are promising with 50% dry and zero patients improved by less than 50%. Long term results are currently missing. During the follow up  there were no complications resulting in system removal, which emphasizes the remarkable safety of this implant.
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Disclosures
Funding None Clinical Trial No Subjects Human Ethics not Req'd Institutional board approval Helsinki Yes Informed Consent Yes